NCT00245128终止2 期
A Phase II Pilot Study to Determine the Safety and Preliminary Efficacy of Imatinib Mesylate (Gleevec) in Patients With Myelofibrosis With Myeloid Metaplasia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well it works in treating patients with myelofibrosis.
详细描述
OBJECTIVES:
Primary
- Determine the safety, efficacy, and tolerability of imatinib mesylate in patients with myelofibrosis with myeloid metaplasia.
- Determine the 3-, 6-, and 12-month major and minor erythroid response rates in patients treated with this drug.
Secondary
- Determine reduction in marrow fibrosis in patients treated with this drug.
- Determine decrease in spleen size in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 myelofibrosis with myeloid metaplasia (MMM), defined by all of the following:
- •Leukoerythroblastic blood picture
- •Fibrosis involving > 1/3 sectional area of bone marrow biopsy
- •Splenomegaly (unless patient has undergone prior splenectomy)
- •Philadelphia chromosome negative
- •No myelodysplastic syndrome
- •No systemic disorders associated with marrow fibrosis
- •Red blood cell transfusion dependent, defined by 1 of the following:
- •Patient has required ≥ 2 units of red blood cells every 4 weeks within the past 8 weeks
- •Hemoglobin ≤ 8 g/dL on ≥ 3 occasions (≥ 2 weeks apart ) over the past 8 weeks
- •No evidence of disease transformation to acute myelogenous leukemia, defined as > 20% blasts in bone marrow and/or peripheral blood
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 50,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST or ALT ≤ 2 times ULN (unless due to extramedullary hematopoiesis in the liver)
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No New York Heart Association grade III-IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier method contraception during and for 3 months after completion of study treatment
- •No serious, uncontrolled medical condition
- •No patients who are considered potentially unreliable or with a history of noncompliance to medical regimens
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 2 weeks since prior interferon alfa
- •Chemotherapy
- •No concurrent chemotherapy except hydroxyurea to control elevated blood counts
- •Endocrine therapy
- •More than 4 weeks since prior corticosteroids, danazol, or other androgens for MMM
- •More than 4 weeks since other prior treatment for MMM
- •No other concurrent experimental drug therapy for MMM
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With Major and/or Minor Erythroid Responses at 3, 6, and 12 Months of Therapy
时间窗: At 3,6, and 12 months of therapy
A major response = transfusion independent or a\>2.0g/dl rise in hemoglobin without transfusion maintained for at least 8 weeks. Minor response= \> 1 to 2.0g/dl incremental rise in hemoglobin maintained for at lease 8 weeks with a decrease in transfusion requirements of at least 50% compared to the mean transfusion requirement during the 8 week pre-study period.
次要结局
- Reduction in Marrow Fibrosis and Decrease in Spleen Size(After 6 and 12 months of therapy)
研究者
研究点 (2)
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