drugset / Trial / NCT01460160
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Phase 2
Completed
106 enrolled
Bristol-Myers Squibb
Children's Oncology Group · collabEsPhALL · collab
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2012-04-13
- Primary completion
- 2017-05-28
- Completion
- 2021-06-01
Outcome
Met primary endpoint
paper The 3-year event-free survival of dasatinib plus chemotherapy was superior to chemotherapy alone PMID 37407142 ↗
registry analysis (superiority test); Dasatinib Cohort; p = 0.032; Estimate of Difference 16.86 (90% CI 3.9 to 29.8); Chi-squared; note: Superiority test versus AIEOP-BFM 2000 NCT01460160 ↗
Publications
- Hunger 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.
- Tasian 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dasatinib anhydrous | Small molecule | 60 mg/m2 | Oral |