NCT00244829已完成1 期
A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 4
- 主要终点
- Safety at 90 days following transplant
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. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia.
PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with high-risk Philadelphia chromosome-positive leukemia.
Secondary
- Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment.
- Determine the 1-year survival of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p^190 and/or p^210 bcr/abl gene rearrangement
- •Accelerated or blastic phase CML
- •CML in second or greater chronic phase
- •No imatinib mesylate-resistant leukemia
- •Planned allogeneic hematopoietic stem cell transplantation
- •Availability of an appropriately matched related or unrelated donor
- •Autologous or nonmyeloablative transplantation is not allowed
- •None of the following within 4 days after the date of neutrophil engraftment*:
- •More than 5% marrow blasts
- •Circulating peripheral blood leukemic blasts
- •Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay
- •Presence of bcr/abl in > 5% of marrow interphase nuclei by fluorescent in situ hybridization
- •More than 1 of 20 Philadelphia chromosome-positive marrow metaphases
- •CNS involvement by leukemia NOTE: *The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •At least 2 months
- •Hematopoietic
- •See Disease Characteristics
- •Absolute neutrophil count ≥ 1,200/mm^3 (use of filgrastim [G-CSF] allowed)
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known imatinib mesylate hypersensitivity
- •No other disease that severely limits life expectancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Safety at 90 days following transplant
次要结局
- BCR/ABL transcript load at 90 days following transplant
- Standard management of progressive minimal residual disease at 90 days following transplant
- Survival at 1 year
研究者
研究点 (4)
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