Dasatinib versus imatinib with chemotherapy for paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CCCG-ALL-2015)
In Chinese children with Philadelphia-positive leukaemia, dasatinib given at a high dose with chemotherapy improved four-year event-free survival compared with imatinib and reduced central nervous system relapses, without cranial irradiation or routine transplant.
Overview
Phase 3 trial of 189 children with Ph-positive ALL randomised to dasatinib 80 mg per square metre or imatinib 300 mg per square metre daily with intensive chemotherapy, without prophylactic cranial irradiation.
Four-year event-free survival was 71.0 percent with dasatinib against 48.9 percent with imatinib, overall survival 88.4 versus 69.2 percent, and the cumulative risk of isolated central nervous system relapse was 2.7 versus 8.4 percent.
- Four-year event-free survival 71.0 percent vs 48.9 percent.
- Isolated central nervous system relapse 2.7 percent vs 8.4 percent.
Dasatinib is preferred over imatinib for paediatric Ph-positive ALL in many protocols because of its central nervous system penetration and superior outcomes in this trial.
- Open-label single-country trial with a higher dasatinib dose than used elsewhere.
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