Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest
研究概览
简要总结
RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant.
PURPOSE: This phase I trial is studying the side effects of G-CSF in stimulating peripheral stem cells for autologous stem cell transplant in treating patients with chronic phase chronic myeloid leukemia in remission.
详细描述
OBJECTIVES:
- Determine the feasibility and safety of harvesting adequate numbers of CD34-positive peripheral blood stem cells using filgrastim (G-CSF) in patients with chronic phase chronic myeloid leukemia in complete cytogenetic remission.
- Determine the safety of temporarily discontinuing treatment with imatinib mesylate and using G-CSF during the harvesting procedure, in terms of the percentage of Philadelphia chromosome (Ph)-positive cells before and after stem cell harvest, in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) and then undergo apheresis for up to 5 days.
After completion of apheresis, patients resume treatment with imatinib mesylate off study. Patients may later undergo autologous peripheral blood stem cell transplantation, when deemed necessary.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.
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 myeloid leukemia
- •In complete cytogenetic remission, confirmed by bone marrow biopsy within the past month
- •Has been receiving imatinib mesylate for ≥ 3 months* NOTE: *Imatinib mesylate is held during the study harvesting procedure
- •No myelofibrosis on bone marrow ≥ 3+
- •Ineligible for or refused allogeneic stem cell transplantation
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 3,000/mm^3
- •Platelet count > 100,000/mm^3
- •Adequate hepatic function for stem cell transplantation
- •Adequate renal function for stem cell transplantation
- •Cardiovascular
- •Adequate cardiovascular function for stem cell transplantation
- •Adequate pulmonary function for stem cell transplantation
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No other concurrent biologic therapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No concurrent radiotherapy
- •No concurrent surgery
- •No other concurrent experimental therapy
排除标准
- 未提供
结局指标
主要结局
Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest
次要结局
- Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest