Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.

Only eligible patients are included in this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual.

→

primary · POSTED

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.

Only eligible patients are included in the analysis.

→

secondary · POSTED

To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.

This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).

→

secondary · POSTED

Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.

4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29

→

secondary · POSTED

Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive.

4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29.

→

secondary · POSTED

Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)

Patients who had MRD day 29 data but their Bone Marrow (BM) days 8/15 data were missing are excluded. This analysis was done with patients who had both MRD and BM data. There were 5 patients excluded in both MRD Negative and MRD Positive groups due to missing days 8/15 BM.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Health-related Quality of Life Relative to Physical, Social and Emotional Impairment

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-acute-lymphoblastic-leukemia-pediatric
nct id: NCT00103285
qol key: qol-0002
source section id: NCT00103285-om-0002
source outcome index: 2
instrument: FACT
instrument basis: matched 'factors' in the study's own wording
scale title: Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
measure definition: To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.
time frame: At 1, 6 and 12 months after diagnosis and, 3 months post-therapy
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Unnamed quality-of-life measure · Optimal Time Point for Advance Health Related Quality of Life Intervention

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-acute-lymphoblastic-leukemia-pediatric
nct id: NCT00103285
qol key: qol-0006
source section id: NCT00103285-om-0006
source outcome index: 6
instrument: Unnamed quality-of-life measure
instrument basis: matched 'health related quality' in the study's own wording
scale title: Optimal Time Point for Advance Health Related Quality of Life Intervention
measure definition: Percentage of patients with elevated Anxiety.
time frame: At 1 month after diagnosis and 3 months post-therapy.
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-acute-lymphoblastic-leukemia-pediatric
nct id: NCT00103285
trial label: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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: 8
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0000
source section id
NCT00103285-om-0000
source outcome index
0
endpoint
Event-free Survival (EFS) for SR-Average ALL Patients
endpoint definition
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
time origin
6 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only eligible patients are included in this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0001
source section id
NCT00103285-om-0001
source outcome index
1
endpoint
Event-free Survival (EFS) for SR-Low Patients
endpoint definition
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
time origin
6 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only eligible patients are included in the analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0002
source section id
NCT00103285-om-0002
source outcome index
2
endpoint
Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
endpoint definition
To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.
time origin
At 1, 6 and 12 months after diagnosis and, 3 months post-therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0003
source section id
NCT00103285-om-0003
source outcome index
3
endpoint
Event-Free Survival Probability According to MRD Status End Induction (Day 29)
endpoint definition
Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
time origin
MRD at Day 29 of therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0004
source section id
NCT00103285-om-0004
source outcome index
4
endpoint
Overall Survival Probability (OS) According to Induction Day 29 MRD Status
endpoint definition
Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive.
time origin
Overall Survival Probability of 6 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
4981 eligible evaluable patients enrolled on AALL0331 had MRD data at Day 29.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0005
source section id
NCT00103285-om-0005
source outcome index
5
endpoint
Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
endpoint definition
Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)
time origin
Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Patients who had MRD day 29 data but their Bone Marrow (BM) days 8/15 data were missing are excluded. This analysis was done with patients who had both MRD and BM data. There were 5 patients excluded in both MRD Negative and MRD Positive groups due to missing days 8/15 BM.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0000
arm key
OG000
arm label
Group 2-SR-avg ALL, Arm I-combination Chemotherapy
regimen
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
analyzed count
500
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0000
arm key
OG001
arm label
Group 2-SR-avg ALL, Arm II-combination Chemotherapy
regimen
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
analyzed count
509
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0000
arm key
OG002
arm label
Group 2-SR-avg ALL, Arm III-combination Chemotherapy
regimen
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
analyzed count
245
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0000
arm key
OG003
arm label
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy
regimen
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
analyzed count
246
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0001
arm key
OG000
arm label
SR-low ALL, Arm I-combination Chemotherapy
regimen
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
analyzed count
928
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0001
arm key
OG001
arm label
SR-low ALL, Arm II-combination Chemotherapy
regimen
Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
analyzed count
929
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0002
arm key
OG000
arm label
Induction Therapy
regimen
All patients for induction therapy.
analyzed count
160
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0003
arm key
OG000
arm label
Induction Therapy, MRD Negative
regimen
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV
analyzed count
4614
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0003
arm key
OG001
arm label
Induction Therapy, MRD Positive
regimen
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV
analyzed count
367
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0004
arm key
OG000
arm label
Induction Therapy, MRD Negative
regimen
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV
analyzed count
4614
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0004
arm key
OG001
arm label
Induction Therapy, MRD Positive
regimen
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV
analyzed count
367
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
outcome key
om-0005
arm key
OG000
arm label
All Patients for Induction, MRD Negative
regimen
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study. cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT vincristine sulfate: Given IV
analyzed count
4609
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00103285-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
harm key
EG000
source section id
NCT00103285-ae
event group key
EG000
event group label
Group 0 Induction Therapy
serious affected
29
serious at risk
1306
other affected
790
other at risk
1306
frequency threshold
0
collection period
Source null
event definition
Only eligible patients are included in the toxicity analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
harm key
EG001
source section id
NCT00103285-ae
event group key
EG001
event group label
Group 1-SR-low ALL, Arm I-combination Chemotherapy
serious affected
14
serious at risk
931
other affected
901
other at risk
931
frequency threshold
0
collection period
Source null
event definition
Only eligible patients are included in the toxicity analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
harm key
EG002
source section id
NCT00103285-ae
event group key
EG002
event group label
Group 1-SR-low ALL, Arm II-combination Chemotherapy
serious affected
7
serious at risk
931
other affected
909
other at risk
931
frequency threshold
0
collection period
Source null
event definition
Only eligible patients are included in the toxicity analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
harm key
EG003
source section id
NCT00103285-ae
event group key
EG003
event group label
Group 2-SR-avg ALL, Arm I-combination Chemotherapy
serious affected
4
serious at risk
501
other affected
487
other at risk
501
frequency threshold
0
collection period
Source null
event definition
Only eligible patients are included in the toxicity analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
harm key
EG004
source section id
NCT00103285-ae
event group key
EG004
event group label
Group 2-SR-avg ALL, Arm II-combination Chemotherapy
serious affected
3
serious at risk
509
other affected
500
other at risk
509
frequency threshold
0
collection period
Source null
event definition
Only eligible patients are included in the toxicity analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
harm key
EG005
source section id
NCT00103285-ae
event group key
EG005
event group label
Group 2-SR-avg ALL, Arm III-combination Chemotherapy
serious affected
0
serious at risk
246
other affected
237
other at risk
246
frequency threshold
0
collection period
Source null
event definition
Only eligible patients are included in the toxicity analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
harm key
EG006
source section id
NCT00103285-ae
event group key
EG006
event group label
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy
serious affected
1
serious at risk
247
other affected
234
other at risk
247
frequency threshold
0
collection period
Source null
event definition
Only eligible patients are included in the toxicity analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
harm key
EG007
source section id
NCT00103285-ae
event group key
EG007
event group label
Group 3-SR-high ALL, Combination Chemotherapy
serious affected
12
serious at risk
638
other affected
629
other at risk
638
frequency threshold
0
collection period
Source null
event definition
Only eligible patients are included in the toxicity analysis.
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
qol key
qol-0002
source section id
NCT00103285-om-0002
source outcome index
2
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
measure definition
To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.
time frame
At 1, 6 and 12 months after diagnosis and, 3 months post-therapy
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).
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-acute-lymphoblastic-leukemia-pediatric
nct id
NCT00103285
qol key
qol-0006
source section id
NCT00103285-om-0006
source outcome index
6
instrument
Unnamed quality-of-life measure
instrument basis
matched 'health related quality' in the study's own wording
scale title
Optimal Time Point for Advance Health Related Quality of Life Intervention
measure definition
Percentage of patients with elevated Anxiety.
time frame
At 1 month after diagnosis and 3 months post-therapy.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these, 159 patients had data at 1 month after diagnosis and 96 patients had data at 3 months post therapy.
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