Title
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
Phase
Phase 2Lead Sponsor
Bristol-Myers SquibbStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Leukemia, PediatricIntervention/Treatment
dasatinib ...Study Participants
106The 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
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
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
| Event Type | Organ System | Event Term | Dasatinib Cohort |
|---|
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
Number of participants experiencing different types of all causality all grade adverse events
Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.
Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.
MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%
A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.
