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) (AALL1122)

Service: Trial Number:
024-11
Principal Investigator: Conducted at:
Miller Children‘s Hospital Long Beach
Currently enrolling additional patients:
Yes
Age Range:
all ages

Dasatinib is a compound used to improve outcome in the treatment of some adult cancers with chemotherapy. The primary objective is to find out how well this medication helps (and what the side effects are) when added to standard chemotherapy for pediatric patients with Philadelphia Chromosome positive Acute lymphoblastic leukemia (Ph+ ALL). Patients newly diagnosed with Ph+ ALL will be eligible for this study and will receive Dasatinib added to the standard chemotherapy for a maximum duration of 2 years. After diagnosis of ALL from the pathology report, patients will be enrolled in a COG trial (AALL08B1) which includes testing for the Philadelphia chromosome. It usually takes up to 10-14 days to determine which patients have Ph+ ALL. Once Ph+ALL is determined, patient will enroll prior to day 15 of the induction chemotherapy onto this study. At day 15, 60 mg/m2 Dasatinib once daily by mouth treatment shall begin and continue until the completion of therapy (102 weeks). Subjects will be seen yearly for 5 years after the completion of therapy with Dasatinib.

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