NCT00112775Unknown2 期
A Randomized Multi-Center Open Label Study of BMS-354825 vs Imatinib Mesylate (Gleevec®) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Iamtinib at a Dose of 400-600 mg/d
适应症
相关药物
试验速览
- 阶段
- 2 期
- 试验地点
- 1
- 主要终点
- Major cytogenic response (MCyR) rate at 12 weeks
研究概览
简要总结
RATIONALE: BMS-354825 and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying BMS-354825 to see how well it works compared to imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia that did not respond to previous imatinib mesylate.
详细描述
OBJECTIVES:
Primary
- Determine the 12-week major cytogenetic response (MCyR) rate in patients with imatinib mesylate-resistant Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia treated with BMS-354825 vs imatinib mesylate.
Secondary
- Determine the MCyR rate prior to crossover in patients treated with these drugs.
- Determine the durability of MCyR and time to MCyR prior to crossover in patients treated with these drugs.
- Determine the complete hematologic response (CHR) rate prior to crossover in patients treated with these drugs.
- Determine the durability of CHR and time to CHR prior to crossover in patients treated with these drugs.
- Determine the major molecular response rate prior to crossover, as determined by BCR-ABL transcripts in blood during treatment using quantitative reverse transcriptase polymerase chain reaction, in patients treated with these drugs.
- Determine post-crossover efficacy endpoints in patients treated with these drugs who crossover.
- Assess health-related quality of life prior to crossover in patients treated with these drugs.
- Determine the safety and tolerability of BMS-354825 in these patients.
- Determine the pharmacokinetics of BMS-354825 in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of chronic phase chronic myelogenous leukemia (CML), meeting all of the following criteria:
- •Less than 15% blasts in peripheral blood and bone marrow
- •Less than 20% basophils in peripheral blood
- •Less than 30% blasts and promyelocytes in peripheral blood and bone marrow
- •Platelet count ≥ 100,000/mm^3 (unless thrombocytopenia is due to recent therapy)
- •No extramedullary involvement (other than liver or spleen)
- •Philadelphia chromosome (Ph)-positive disease by cytogenetic analysis
- •Must have developed resistant disease during prior treatment with imatinib mesylate* at a dose of 400-600 mg/day**, as defined by 1 of the following:
- •Loss of major cytogenetic response (MCyR)
- •Achieved a confirmed MCyR and subsequently no longer meets the MCyR criteria
- •Documented increase in Ph-positive metaphases by 30% on 2 cytogenetic analyses performed ≥ 4 weeks apart during treatment with imatinib mesylate
- •Loss of complete hematologic response (CHR)
- •Achieved a confirmed CHR and subsequently no longer meets the CHR criteria on all asessments over a consecutive 2-week period during treatment with imatinib mesylate
- •Continuously increasing WBC count on ≥ 2 consecutive evaluations ≥ 2 weeks apart with the final assessment showing a doubling of WBC from the nadir to ≥ 20,000/mm^3 OR an absolute increase in WBC by > 50,000/mm^3 above the lowest count after starting imatinib mesylate
- •No CHR after 3 months of treatment with imatinib mesylate at a dose of 400-600 mg/day
- •No cytogenetic response after 6 months of treatment with imatinib mesylate at a dose of 400-600 mg/day
- •No MCyR after 12 months of treatment with imatinib mesylate at a dose of 400-600 mg/day NOTE: *Imatinib mesylate does not need to be the most recent treatment for CML
- •NOTE: **Imatinib mesylate dose ≤ 600 mg/day
- •Able to tolerate chronic administration of imatinib mesylate at the highest dose received during prior treatment
- •No imatinib mesylate-related non-hematologic toxicity ≥ grade 3
- •No grade 4 imatinib mesylate-related hematologic toxicity lasting more than 7 days
- •No imatinib mesylate-related toxicity that led to discontinuation or disruption of dosing for > 4 weeks
- •No previously identified BCR-ABL mutation of 1 of the following types:
- •No prior diagnosis of accelerated phase or blast crisis CML
- •Patients who previously met the criteria for accelerated phase or blast crisis CML who achieved CHR during treatment with imatinib mesylate and then subsequently progressed to chronic phase CML are not eligible
- •Ineligible for or unwilling to undergo hematopoietic stem cell transplantation
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •See Disease Characteristics
- •No history of a significant bleeding disorder unrelated to CML, including any of the following:
- •Congenital bleeding disorder (e.g., von Willebrand's disease)
- •Acquired bleeding disorder diagnosed within the past year (e.g. acquired anti-factor VIII antibodies)
- •Bilirubin ≤ 2.0 times upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Total serum or ionized calcium normal (supplementation allowed)
- •Cardiovascular
- •Heart rate ≥ 50 beats/minute by EKG
- •No myocardial infarction within the past 6 months
- •No uncontrolled angina within the past 3 months
- •No congestive heart failure within the past 3 months
- •No diagnosed or suspected congenital long QT syndrome
- •No history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de Pointes)
- •No prolonged QTc interval (i.e., > 450 msec) by EKG using Bazett's correction
- •High Bazett's correction (i.e., > 450 msec) allowed provided Fridericia correction is ≤ 450 msec
- 另有 71 项未显示
排除标准
- 未提供
结局指标
主要结局
Major cytogenic response (MCyR) rate at 12 weeks
次要结局
- MCyR at any time
- Duration of MCyR
- Time to MCyR
- Complete hematologic response rate
研究者
研究点 (1)
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