Leukemia Clinical Trial
Official title:
An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).
The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.
1. Design:
Study Design and Duration as current described are no longer applicable since
enrollment was prematurely concluded due to a decision by the sponsor. Subjects
currently enrolled in the trial will continue to receive dasatinib alone at a starting
dose of 100 mg QD for:
1. a maximum of 5 years after entry into the study
2. until progression by Investigators determination/judgment
3. intolerance to Dasatinib
4. the study is terminated due to safety concerns or
5. other administrative reasons as communicated by the sponsor
2. Research Hypothesis :
The research hypothesis and primary objective of this study as originally designed are no
longer applicable as subjects enrolment has been terminated due to administrative reasons by
the sponsor. The objective of the altered design of this study is to describe the safety
profile and tolerability of dasatinib
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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