Allogeneic Bone Marrow Transplantation for Patients With Chronic Myelogenous Leukemia in the Chronic Phase or Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation in treating patients who have multiple myeloma, chronic phase chronic myelogenous leukemia, or agnogenic myeloid metaplasia.
详细描述
OBJECTIVES:
- Determine the efficacy of allogeneic bone marrow transplantation (BMT) following high-dose cyclophosphamide and total body irradiation in patients with multiple myeloma, agnogenic myeloid metaplasia, or chronic myelogenous leukemia in first or second chronic phase.
- Determine the efficacy of BMT following busulfan and cyclophosphamide in these patients.
- Determine the toxic effects of these preparative regimens in these patients.
OUTLINE: Patients are stratified by remission (first vs second vs third).
Patients who have not undergone prior radiotherapy receive cyclophosphamide IV on days -6 and -5 and then undergo total body irradiation twice a day on days -4 to -1. Allogeneic bone marrow is infused on day 0.
Patients who have undergone prior radiotherapy receive oral busulfan every 6 hours on days -7 to -4 or -6 to -3 and cyclophosphamide IV over 2 hours on days -3 and -2. Allogeneic bone marrow is infused on day 0.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Cytologically proven disease of one of the following types with transfusion-dependent anemia or thrombocytopenia (less than 50,000/mm^3):
- •Multiple myeloma
- •Agnogenic myeloid metaplasia
- •Chronic myelogenous leukemia in first or second chronic phase
- •Philadelphia chromosome with BCR gene rearrangement
- •Suitable sibling bone marrow donor available
- •PATIENT CHARACTERISTICS:
- •15 to physiologic 55
- •Performance status:
- •ECOG 0 or 1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Bilirubin no greater than 2.0 mg/dL
- •SGOT less than 2 times normal
- •Alkaline phosphatase less than 2 times normal
- •Creatinine less than 2 mg/dL
- •Cardiovascular:
- •Ejection fraction normal by MUGA
- •No acute myocardial infarction within the past 6 months
- •No active angina pectoris
- •No active congestive heart failure
- •FEV greater than 50% predicted
- •DLCO at least 50%
- •HIV negative
- •No active infection
- •No concurrent organ damage or medical problems that would preclude therapy
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供