An Open-label, Phase II Study to Explore the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL)
Recent advances in treatment have increased the cure of childhood ALL to 75% or better.
However, attempts to improve results for resistant subtypes of ALL, such as Ph+ ALL, have
been largely unsuccessful. Imatinib, an inhibitor of protein-tyrosine kinases, is currently
being tested in several phase I, II and III trials covering most Chronic Myeloid Leukemia
patient populations and patients with overtly relapsed or refractory Ph+ALL. Pediatric
patients with Ph+ALL will receive Imatinib, added to intensive, post-induction BFM-type
chemotherapy. The endpoint will be the evaluation on the long-term clinical outcome, in
particular on the Disease Free Survival (DFS).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival (DFS). DFS will be calculated as the time from inclusion to either one of the following events: relapse, death in CCR, second malignancies.
Andrea Biondi, MD
Ospedale S. Gerardo - Monza
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)