International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
Objective
Primary Aims To compare disease free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a high-risk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. Secondary Aims To determine the feasibility of administration of imatinib after allogeneic HSCT in High Risk (HR) Ph+ ALL patients. To determine event-free survival (EFS) of High Risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib. To compare rates of Grade 3 or higher infections in SR Ph+ ALL patients between the two randomized arms. To evaluate EFS and overall survival (OS) of all enrolled participants. To evaluate OS in SR patients.To evaluate OS in HR patients.
