TriangleNCT01606878 · STUDY IN CONTEXT
Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The MTD of crizotinib administered with combination chemotherapy based on the incidence of dose-limiting toxicity (DLT) at which fewer than one-third of patients experience DLT, as assessed by NCI CTCAE version 4.0.
Number of patients of all DLT reported as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. stratified by dose level and study part.
Median (min, max) of the area under the concentration time curve for crizotinib assessed in course 1 at 1, 2, 4, 6-8 hours, and 15-21 days post-administration stratified by dose level and study part.
Number of patients of response-evaluable participants with response (CR/PR) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in the sum of the diameters of target lesions
Number of patients who respond (CR/PR) to crizotinib in combination with either topotecan and cyclophosphamide or vincristine and doxorubicin/dexraroxane stratified by ALK positive or negative status
Frequency (%) of patients who respond (CR/PR) to crizotinib in combination with either topotecan and cyclophosphamide or vincristine and doxorubicin/dexraroxane stratified by MRD status
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- trial label
- Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 11
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0000
- source section id
- NCT01606878-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose (MTD) of Crizotinib
- endpoint definition
- The MTD of crizotinib administered with combination chemotherapy based on the incidence of dose-limiting toxicity (DLT) at which fewer than one-third of patients experience DLT, as assessed by NCI CTCAE version 4.0.
- time origin
- Up to 21 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Parts A, B and D MTD/RP2D were not assessed. As of Amendment #3, due to the possibility that many of the non-hematologic DLTs observed to date on the study are related to the palatability of the OS rather than due to true toxicity of the investigational agent, Parts A and B were closed and Part C was then opened to determine the MTD/ RP2D. As of Amendment #4, a new microsphere formulation was added for Part D, but there was no MTD/RP2D.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- source section id
- NCT01606878-om-0001
- source outcome index
- 1
- endpoint
- Number of Patients With Dose Limiting Toxicity (DLT)
- endpoint definition
- Number of patients of all DLT reported as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. stratified by dose level and study part.
- time origin
- Up to 21 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All Toxicity evaluable patients
- 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-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0002
- source section id
- NCT01606878-om-0002
- source outcome index
- 2
- endpoint
- Area Under the Concentration
- endpoint definition
- Median (min, max) of the area under the concentration time curve for crizotinib assessed in course 1 at 1, 2, 4, 6-8 hours, and 15-21 days post-administration stratified by dose level and study part.
- time origin
- Up to 21 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All Toxicity evaluable patients. There were no data for Part A Dose Level 2, Part B Dose Level 3, and Part D Dose Level 1.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0003
- source section id
- NCT01606878-om-0003
- source outcome index
- 3
- endpoint
- Response Rate
- endpoint definition
- Number of patients of response-evaluable participants with response (CR/PR) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in the sum of the diameters of target lesions
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable patients for response
- 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-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0004
- source section id
- NCT01606878-om-0004
- source outcome index
- 4
- endpoint
- ALK Status and Response to Crizotinib
- endpoint definition
- Number of patients who respond (CR/PR) to crizotinib in combination with either topotecan and cyclophosphamide or vincristine and doxorubicin/dexraroxane stratified by ALK positive or negative status
- time origin
- up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Neuroblastoma patients
- 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-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0005
- source section id
- NCT01606878-om-0005
- source outcome index
- 5
- endpoint
- MRD Status and Response to Crizotinib
- endpoint definition
- Frequency (%) of patients who respond (CR/PR) to crizotinib in combination with either topotecan and cyclophosphamide or vincristine and doxorubicin/dexraroxane stratified by MRD status
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Outcome Measure was specific to ALCL patients. There were zero ALCL patients, therefore, there are no data to report.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part C (Crizotinib, Cyclophosphamide, Topotecan Hydrochloride)
- regimen
- Patients receive crizotinib (capsule formulation) PO BID, cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part A Dose Level 1
- regimen
- Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part A Dose Level 2
- regimen
- Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID on days 1-21, 250 mg/m\^2 cyclophosphamide IV QD on days 1-5, and topotecan hydrochloride IV QD on days 1-5. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Part B Dose Level 1
- regimen
- Patients receive 165 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Part B Dose Level 2
- regimen
- Patients receive 215 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Part B Dose Level 3
- regimen
- Patients receive 280 mg/m\^2 crizotinib (oral solution) PO BID as in Part A. Patients also receive 1.5 mg/m\^2 vincristine sulfate IV on day 1, 450 mg/m\^2 dexrazoxane hydrochloride IV on day 1, and 45 mg/m\^2 doxorubicin hydrochloride IV over 15 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/3/14)
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG005
- arm label
- Part C Dose Level 1
- regimen
- Patients receive 165 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG006
- arm label
- Part C Dose Level 2
- regimen
- Patients receive 215 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG007
- arm label
- Part C Dose Level 3
- regimen
- Patients receive 280 mg/m\^2 crizotinib (capsule formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG008
- arm label
- Part D Dose Level 1
- regimen
- Patients receive 165 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG009
- arm label
- Part D Dose Level 2
- regimen
- Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG009
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- outcome key
- om-0001
- arm key
- OG010
- arm label
- Part PK Dose Level 2
- regimen
- Patients receive 215 mg/m\^2 crizotinib (microsphere formulation) PO BID, 250 mg/m\^2 cyclophosphamide IV QD, and topotecan hydrochloride IV QD as in Part A. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01606878-om-0001#groups/OG010
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG000
- source section id
- NCT01606878-ae
- event group key
- EG000
- event group label
- Part A Dose Level 1
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG001
- source section id
- NCT01606878-ae
- event group key
- EG001
- event group label
- Part A Dose Level 2
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG002
- source section id
- NCT01606878-ae
- event group key
- EG002
- event group label
- Part B Dose Level 1
- serious affected
- 1
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG003
- source section id
- NCT01606878-ae
- event group key
- EG003
- event group label
- Part B Dose Level 2
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG004
- source section id
- NCT01606878-ae
- event group key
- EG004
- event group label
- Part B Dose Level 3
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG005
- source section id
- NCT01606878-ae
- event group key
- EG005
- event group label
- Part C Dose Level 1
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG006
- source section id
- NCT01606878-ae
- event group key
- EG006
- event group label
- Part C Dose Level 2
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG007
- source section id
- NCT01606878-ae
- event group key
- EG007
- event group label
- Part C Dose Level 3
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG008
- source section id
- NCT01606878-ae
- event group key
- EG008
- event group label
- Part D Dose Level 1
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG009
- source section id
- NCT01606878-ae
- event group key
- EG009
- event group label
- Part D Dose Level 2
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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-recurrent-c5218487
- nct id
- NCT01606878
- harm key
- EG010
- source section id
- NCT01606878-ae
- event group key
- EG010
- event group label
- Part PK Dose Level 2
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Up to 2 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). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.
- 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
- setting source links
Preserved source evidence · Not medical advice