TriangleNCT00702403 · STUDY IN CONTEXT
Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML
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
Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.
To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (\>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, \>5% BCR/ABL in marrow by fluorescent in situ hybridization, or \>1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).
The proportion of study participants alive at 1, 2 and 3 years
The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year
The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia
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-acute-lymphoblastic-leukemia-pediatric-recurrent-57967c09
- nct id
- NCT00702403
- trial label
- Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML
- 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
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0000
- source section id
- NCT00702403-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Treatment Safety Failure
- endpoint definition
- Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.
- time origin
- Up to 365 days post-transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Critical to note are two "intention-to-treat" populations: the 1st (N=57) at time of consent, evolved into the second ITT population (N=40), because 17 subjects lost eligibility to begin relapse prophylaxis at engraftment. A 2nd wave of discontinuations occurred at or after Day 81 when all patients were to be switched from imatinib to nilotinib.
- 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-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0001
- source section id
- NCT00702403-om-0001
- source outcome index
- 1
- endpoint
- The Proportion of Patients at 1 Year With Treatment Efficacy Success
- endpoint definition
- To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (\>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, \>5% BCR/ABL in marrow by fluorescent in situ hybridization, or \>1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).
- time origin
- Up to 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The analysis population was considered in two ways: first the number of treatment success in the entire cohort (by "intention to treat"), and second the number of treatment successes among only those patients who did not die before 1 year from non-relapse mortality.
- 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-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0002
- source section id
- NCT00702403-om-0002
- source outcome index
- 2
- endpoint
- Survival
- endpoint definition
- The proportion of study participants alive at 1, 2 and 3 years
- time origin
- Up to 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Overall Survival (complete follow-up is available out to three years for all 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-acute-lymphoblastic-leukemia-pediatric-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0003
- source section id
- NCT00702403-om-0003
- source outcome index
- 3
- endpoint
- Patients Alive With Out Relapse
- endpoint definition
- The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year
- time origin
- Up to 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Proportion alive without relapse among the total number of patients with minimal residual disease follow-up data
- 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-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0004
- source section id
- NCT00702403-om-0004
- source outcome index
- 4
- endpoint
- Relapse
- endpoint definition
- The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia
- time origin
- 1 and 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia among those who did not die from non-relapse causes during the first year, and first 3-years after transplant.
- 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-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Single Arm Nilotinib Relapse Prophylaxis
- regimen
- Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00702403-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)
- regimen
- Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00702403-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)
- regimen
- Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity. nilotinib: Given PO imatinib mesylate: Given PO pharmacological study: Correlative studies
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00702403-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Single Arm Nilotinib Relapse Prophylaxis
- regimen
- Beginning after engraftment and blood counts recover (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood counts recover until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00702403-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric-recurrent-57967c09
- nct id
- NCT00702403
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Prophylactic Inhibition of BCR-ABL Tyrosine Kinase)
- regimen
- Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO once daily until day 80 and then nilotinib PO twice daily on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO twice daily beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00702403-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric-recurrent-57967c09
- nct id
- NCT00702403
- harm key
- EG000
- source section id
- NCT00702403-ae
- event group key
- EG000
- event group label
- Single Arm Nilotinib Relapse Prophylaxis
- serious affected
- 20
- serious at risk
- 40
- other affected
- 31
- other at risk
- 40
- frequency threshold
- 0
- collection period
- Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
- event definition
- Source null
- 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