Conditions: Leukemia
Keywords: Myelogenous Chronic BCR-ABL Positive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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   Study Design and Duration as current described are no longer applicable since enrollment was prematurely concluded due to a decision by the sponsor.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The research hypothesis and primary objective of this study as originally designed are no longer applicable as subjects enrolment has been terminated due to administrative reasons by the sponsor.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

Arms:
arm 1: None arm 2: Dasatinib for 1 year followed by dasatinib plus BMS-833923 for 2 years followed by dasatinib alone for approximately 2 years; depending on response

Interventions: intervention 1: Dasatinib intervention 2: BMS-833923
Intervention descriptions: intervention 1: Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response intervention 2: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response

Protocol document: