Clinical trial · Interventional
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT01460160CI-TRIAL-00055423completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Pediatric | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1: Dasatinib
- interventionNames
- Drug: Dasatinib
Primary outcomes (1)
- measure
- 3-year Event-free Survival (EFS) Rate
- timeFrame
- From first dose to 3 years following first dose
- description
- 3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following: * Lack of complete response in bone marrow * Relapse at any site * Development of second malignant neoplasm * Death from any cause
Secondary outcomes (5)
- measure
- Number of Participants Experiencing Adverse Events
- timeFrame
- From first dose to 100 days following last dose (up to approximately 23 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL) * Age \>1 year and \< less than 18 years old * Induction chemotherapy ≤ 14 days according to institutional standard of care * Adequate liver, renal and cardiac function Exclusion Criteria: * Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor * Extramedullary involvement of the testicles * Active systemic bacterial, fungal or viral infection * Down syndrome
References
Publications (2)
- DERIVEDHunger SP, Tran TH, Saha V, Devidas M, Valsecchi MG, Gastier-Foster JM, Cazzaniga G, Reshmi SC, Borowitz MJ, Moorman AV, Heerema NA, Carroll AJ, Martin-Regueira P, Loh ML, Raetz EA, Schultz KR, Slayton WB, Cario G, Schrappe M, Silverman LB, Biondi A. Dasatinib with intensive chemotherapy in de novo paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CA180-372/COG AALL1122): a single-arm, multicentre, phase 2 trial. Lancet Haematol. 2023 Jul;10(7):e510-e520. doi: 10.1016/S2352-3026(23)00088-1. PMID 37407142
- DERIVEDTasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available. PMID 33242441