NCT01190930 · STUDY IN CONTEXT
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.
Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0007
- source section id
- NCT01190930-om-0007
- source outcome index
- 7
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2 Months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0008
- source section id
- NCT01190930-om-0008
- source outcome index
- 8
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1 year
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0009
- source section id
- NCT01190930-om-0009
- source outcome index
- 9
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1.7 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0010
- source section id
- NCT01190930-om-0010
- source outcome index
- 10
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2.5 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0011
- source section id
- NCT01190930-om-0011
- source outcome index
- 11
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 3.2 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR boy patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0012
- source section id
- NCT01190930-om-0012
- source outcome index
- 12
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
- measure definition
- Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2 Months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0013
- source section id
- NCT01190930-om-0013
- source outcome index
- 13
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1 Year
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0014
- source section id
- NCT01190930-om-0014
- source outcome index
- 14
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1.7 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0015
- source section id
- NCT01190930-om-0015
- source outcome index
- 15
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2.4 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0016
- source section id
- NCT01190930-om-0016
- source outcome index
- 16
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 3.2 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR boy patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0017
- source section id
- NCT01190930-om-0017
- source outcome index
- 17
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2 Months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0018
- source section id
- NCT01190930-om-0018
- source outcome index
- 18
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1 Year
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0019
- source section id
- NCT01190930-om-0019
- source outcome index
- 19
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1.7 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0020
- source section id
- NCT01190930-om-0020
- source outcome index
- 20
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2.4 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in Boy AR Patients Overall at End of Therapy: School
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0021
- source section id
- NCT01190930-om-0021
- source outcome index
- 21
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 3.2 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0022
- source section id
- NCT01190930-om-0022
- source outcome index
- 22
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
- measure definition
- Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2 Months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0023
- source section id
- NCT01190930-om-0023
- source outcome index
- 23
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
- measure definition
- Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1 Year
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0024
- source section id
- NCT01190930-om-0024
- source outcome index
- 24
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
- measure definition
- Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1.7 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0025
- source section id
- NCT01190930-om-0025
- source outcome index
- 25
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
- measure definition
- Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2.4 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0026
- source section id
- NCT01190930-om-0026
- source outcome index
- 26
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
- measure definition
- Age standardized Quality of life, measured by the Social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 3.2 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR boy patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0027
- source section id
- NCT01190930-om-0027
- source outcome index
- 27
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
- time frame
- 1.7 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0028
- source section id
- NCT01190930-om-0028
- source outcome index
- 28
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
- time frame
- 2.4 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0029
- source section id
- NCT01190930-om-0029
- source outcome index
- 29
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
- time frame
- 3.2 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR boy patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0030
- source section id
- NCT01190930-om-0030
- source outcome index
- 30
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
- time frame
- 1.7 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0031
- source section id
- NCT01190930-om-0031
- source outcome index
- 31
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
- time frame
- 2.4 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0032
- source section id
- NCT01190930-om-0032
- source outcome index
- 32
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
- time frame
- 3.2 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR boy patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0033
- source section id
- NCT01190930-om-0033
- source outcome index
- 33
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
- time frame
- 1.7 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0034
- source section id
- NCT01190930-om-0034
- source outcome index
- 34
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
- time frame
- 2.4 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0035
- source section id
- NCT01190930-om-0035
- source outcome index
- 35
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
- time frame
- 3.2 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0036
- source section id
- NCT01190930-om-0036
- source outcome index
- 36
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
- measure definition
- Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
- time frame
- 1.7 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0037
- source section id
- NCT01190930-om-0037
- source outcome index
- 37
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
- measure definition
- Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
- time frame
- 2.4 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0038
- source section id
- NCT01190930-om-0038
- source outcome index
- 38
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
- measure definition
- Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
- time frame
- 3.2 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR boy patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- trial label
- Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 10
- qol Count
- 32
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0000
- source section id
- NCT01190930-om-0000
- source outcome index
- 0
- endpoint
- Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
- endpoint definition
- DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
- time origin
- 5.7 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Average Risk (AR) B-ALL patients who were randomized and started maintenance
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0001
- source section id
- NCT01190930-om-0001
- source outcome index
- 1
- endpoint
- DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
- endpoint definition
- DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
- time origin
- 5.7 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Average Risk (AR) B-ALL patients who were randomized and started maintenance
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0002
- source section id
- NCT01190930-om-0002
- source outcome index
- 2
- endpoint
- DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
- endpoint definition
- DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
- time origin
- 5.1 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0003
- source section id
- NCT01190930-om-0003
- source outcome index
- 3
- endpoint
- DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
- endpoint definition
- DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.
- time origin
- 5.1 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0004
- source section id
- NCT01190930-om-0004
- source outcome index
- 4
- endpoint
- Sample Collection of Central Path Review Slides in B-LLy Patients
- endpoint definition
- Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
- time origin
- Up to 1 month
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- patients who had samples collected near diagnosis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0005
- source section id
- NCT01190930-om-0005
- source outcome index
- 5
- endpoint
- Event Free Survival (EFS) for B-LLy Patients
- endpoint definition
- EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.
- time origin
- 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Ineligible patients are excluded
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0000
- arm key
- OG000
- arm label
- B-ALL Average Risk: MTX 20 mg/m^2/Week Starting Dose
- regimen
- Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
- analyzed count
- 1186
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0000
- arm key
- OG001
- arm label
- B-ALL Average Risk: MTX 40 mg/m^2/Week Starting Dose
- regimen
- Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
- analyzed count
- 1178
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0001
- arm key
- OG000
- arm label
- B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
- regimen
- Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
- analyzed count
- 1186
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0001
- arm key
- OG001
- arm label
- B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks
- regimen
- Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
- analyzed count
- 1178
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0002
- arm key
- OG000
- arm label
- B-ALL Low Risk Arm I (LR-M)
- regimen
- Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX\* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1\&4), d 57 (course 2\&5), d29 (course 3\&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. \*Patients do not receive MTX PO on d w/ IT MTX.
- analyzed count
- 301
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0002
- arm key
- OG001
- arm label
- B-ALL Low Risk Arm II (LR-C)
- regimen
- Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN \& IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN \& doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN \& IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
- analyzed count
- 302
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Standard Risk With Down Syndrome
- regimen
- Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN \& IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN \& doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN \& IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
- analyzed count
- 224
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0004
- arm key
- OG000
- arm label
- B-LLy
- regimen
- Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
- analyzed count
- 39
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- outcome key
- om-0005
- arm key
- OG000
- arm label
- B-LLy
- regimen
- Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
- analyzed count
- 48
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01190930-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG000
- source section id
- NCT01190930-ae
- event group key
- EG000
- event group label
- B-ALL
- serious affected
- 72
- serious at risk
- 9229
- other affected
- 1776
- other at risk
- 9229
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG001
- source section id
- NCT01190930-ae
- event group key
- EG001
- event group label
- B-LLy
- serious affected
- 0
- serious at risk
- 48
- other affected
- 30
- other at risk
- 48
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG002
- source section id
- NCT01190930-ae
- event group key
- EG002
- event group label
- B-ALL Average Risk
- serious affected
- 16
- serious at risk
- 3122
- other affected
- 1037
- other at risk
- 3122
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG003
- source section id
- NCT01190930-ae
- event group key
- EG003
- event group label
- Standard Risk With Down Syndrome
- serious affected
- 9
- serious at risk
- 224
- other affected
- 191
- other at risk
- 224
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG004
- source section id
- NCT01190930-ae
- event group key
- EG004
- event group label
- B-ALL Low Risk Arm I (LR-M)
- serious affected
- 0
- serious at risk
- 301
- other affected
- 103
- other at risk
- 301
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG005
- source section id
- NCT01190930-ae
- event group key
- EG005
- event group label
- B-ALL Low Risk Arm II (LR-C)
- serious affected
- 0
- serious at risk
- 302
- other affected
- 143
- other at risk
- 302
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG006
- source section id
- NCT01190930-ae
- event group key
- EG006
- event group label
- B-ALL Average Risk-Arm A
- serious affected
- 7
- serious at risk
- 600
- other affected
- 180
- other at risk
- 600
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG007
- source section id
- NCT01190930-ae
- event group key
- EG007
- event group label
- B-ALL Average Risk-Arm B
- serious affected
- 7
- serious at risk
- 586
- other affected
- 204
- other at risk
- 586
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG008
- source section id
- NCT01190930-ae
- event group key
- EG008
- event group label
- B-ALL Average Risk-Arm C
- serious affected
- 4
- serious at risk
- 586
- other affected
- 156
- other at risk
- 586
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- harm key
- EG009
- source section id
- NCT01190930-ae
- event group key
- EG009
- event group label
- B-ALL Average Risk-Arm D
- serious affected
- 3
- serious at risk
- 592
- other affected
- 152
- other at risk
- 592
- frequency threshold
- 0
- collection period
- Up to 9 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0007
- source section id
- NCT01190930-om-0007
- source outcome index
- 7
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2 Months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0008
- source section id
- NCT01190930-om-0008
- source outcome index
- 8
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1 year
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0009
- source section id
- NCT01190930-om-0009
- source outcome index
- 9
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1.7 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0010
- source section id
- NCT01190930-om-0010
- source outcome index
- 10
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2.5 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0011
- source section id
- NCT01190930-om-0011
- source outcome index
- 11
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
- measure definition
- Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 3.2 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR boy patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0012
- source section id
- NCT01190930-om-0012
- source outcome index
- 12
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
- measure definition
- Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2 Months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0013
- source section id
- NCT01190930-om-0013
- source outcome index
- 13
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1 Year
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0014
- source section id
- NCT01190930-om-0014
- source outcome index
- 14
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1.7 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0015
- source section id
- NCT01190930-om-0015
- source outcome index
- 15
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2.4 Years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0016
- source section id
- NCT01190930-om-0016
- source outcome index
- 16
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
- measure definition
- Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 3.2 years
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- AR boy patients who had data collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0017
- source section id
- NCT01190930-om-0017
- source outcome index
- 17
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 2 Months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric
- nct id
- NCT01190930
- qol key
- qol-0018
- source section id
- NCT01190930-om-0018
- source outcome index
- 18
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
- measure definition
- Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
- time frame
- 1 Year
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Data are unavailable
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice
Triangle