Grants and Contracts Details
Confidential Human Clinical Trial Phase 2 Official Title: 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 Purpose The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia Further study details as provided by Bristol-Myers Squibb: Primary Outcome Measures: •Event free survival (EFS) rate at 3 years of Dasatinib plus chemotherapy compared with external historical controls [ Time Frame: Three years following the 75th patient's first visit ] [ Designated as safety issue: No ] Secondary Outcome Measures: •Safety and feasibility of Dasatinib added to standard chemotherapy [ Time Frame: Up to 2 years from first dose of Dasatinib ] [ Designated as safety issue: Yes ] Based on adverse events and laboratory results •Event free survival rate at 3 and 5 years [ Time Frame: 3 and 5 years following the 75th patient's first visit ] [ Designated as safety issue: No ] •Minimal Residual Disease levels [ Time Frame: At approximately 2 weeks, 8 weeks, 20 weeks after starting Dasatinib and at progression (up to 5 years after last dose of Dasatinib) ] [ Designated as safety issue: No ] •Complete Remission Rates [ Time Frame: At 8 weeks and between week 17 and 20 after starting Dasatinib ] [ Designated as safety issue: No ] Estimated Enrollment: 75 Study Start Date: May 2012 Estimated Study Completion Date: February 2022 Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
|Effective start/end date||5/1/12 → 4/30/14|
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