Phase 2
Completed N=106
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT01460160 ↗Enrolled (actual)
106
Serious AEs
95.3%
Results posted
Aug 2018
Primary outcomePrimary: 3-year Event-free Survival (EFS) Rate — 66.0 Percentage of Participants — p=0.032
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3-year Event-free Survival (EFS) Rate |
66.0 | 0.032 sig |
| SECONDARY Number of Participants Experiencing Adverse Events |
106; 88; 7; 101; 15 | — |
| SECONDARY Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) |
65.5; 53.1 | — |
| SECONDARY Complete Remission Rate |
65.1; 88.7; 93.4 | — |
| SECONDARY Percentage of Participants Negative for Minimal Residual Disease (MRD) |
28.3; 52.8; 71.7 | — |
| SECONDARY Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse |
1.3; 6.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01460160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.