A Phase II Study of BMS-354825 in Subjects with Accelerated Phase Chronic MyeloidLeukemia Resistant to or Intolerant of Imatinib MesylateRevised Protocol 01: Incorporates Amendment 03 and Administrative Letter dated 01-March-2005.Amendment 01 country specific version 1.0 dated 2005-03-14
- Conditions
- Accelerated Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
- Registration Number
- EUCTR2004-002515-89-SE
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 256
1) Subjects with Ph+ (or BCR/ABL+) accelerated phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
Subjects are considered to have accelerated phase CML if they meet at least one of
the following criteria:
• At least 15% to < 30% blasts in peripheral blood or 15% to < 30% blasts in bone
marrow
• The sum of the percent blasts plus percent promyelocytes in peripheral blood or in
the bone marrow is = 30% (but the percent blasts alone is < 30%) and in bone
marrow
• = 20% basophils in peripheral blood or in bone marrow
• Platelets < 100,000/mm3 unrelated to drug therapy
2) ECOG performance status score 0 - 2 (See Appendix 1)
3) Adequate hepatic function defined as:
• total bilirubin = 2.0 times the institutional upper limit of normal
• alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times the institutional upper limit of normal
4) Adequate renal function defined as:
• serum creatinine = 1.5 times the institutional upper normal limit
5) Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower
limit of normal.
6) Men and women, 18 years of age or older.
Are the trial subjects under 18? no
Number of subjects for this age range:
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
1) Women who are pregnant or breastfeeding.
2) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least 1 month before and for at least 3 months after completion of the study medication.
3) Subjects who are eligible and willing to undergo transplantation during the screening period.
4) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
5) Uncontrolled or significant cardiovascular disease
6) Subjects who received:
- imatinib mesylate within 7 days
- interferon or cytarabine within 14 days
- a targeted small molecule anti-cancer agent within 14 days,
- any other investigational or antineoplastic agent other than hydroxyurea within 28 days before starting treatment with BMS-354825
7) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes
8) Subjects taking medications that irreversibly inhibit platelet function
9) Prior therapy with BMS-354825.
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