CA180-372 ( COG Protocol AALL1122): A Phase 2 Multi-Center Historically - Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
This research is being done to find out what the survival rate is when an investigational drug called dasatinib is added to a standard chemotherapy for newly diagnosed Philadelphia-positive childhood ALL. Dasatinib is currently approved by the U.S. Food and Drug Administration (FDA) and regulatory authorities in about 50 other countries for subjects who have chronic myeloid leukemia (CML), and for use in adults with acute lymphoblastic leukemia (ALL) called Philadelphia Positive chromosome (Ph+) ALL that has worsened after treatment with another treatment. Dasatinib has not been approved for use in children. It is not approved for use in newly diagnosed Ph+ ALL. The use of dasatinib in this study is considered investigational. The FDA is allowing the use of dasatinib in this research study.
Philadelphia chromosome-positive ALL Induction chemotherapy approximately less than / equal to 14 days according to institutional standard of care Adequate organ function Age greater than 1 year and less than 18 years at diagnosis Excluded: prior treatment with a BCR-ABL inhibitor, testicular involvement with ALL, Down syndrome, active systemic infection
The components of treatment are divided into blocks as follows: â?¢ Induction IA (4 - 5 weeks) â?¢ Induction IB (28 days, 4 weeks) â?¢ Recovery period (Dasatinib continues, No chemotherapy given) (2 - 4 weeks) â?¢ Consolidation blocks 1, 2, and 3 (21 days, 3 weeks each) â?¢ Recovery period (Dasatinib continues, No chemotherapy given) (14 days, 2 weeks) â?¢ Reinduction block 1, including phase IIa and IIb (63 days, 9 weeks) â?¢ Interim maintenance (29 days, 4 weeks, overlaps 2 weeks with end of reinduction block 1) â?¢ Reinduction block 2 (63 days, 9 weeks) â?¢ Continuation therapy (62 weeks)
06/19/2013 04:02 AM