A randomized two-arm, multicenter, open-label phase III study of BMS-354825 administered orally at a dose of 70 mg twice daily or 140 mg once daily in subjects with chronic myeloid leukemia in accelerated phase or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec). Revised protocol 06, incorporating administrative letters 01, 02, and 03 and amendments 01, 02, 03, 04 (v1.0 dated 28 Feb 2008) and 05 (v1.0 dated 19 Dec 2008).
- Conditions
- Subjects with chronic myeloid leukemia in accelerated phase or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate.MedDRA version: 14.1Level: HLGTClassification code 10024324Term: LeukaemiasSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-001169-32-IT
- Lead Sponsor
- BRISTOL-M.SQUIBB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method