Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose Busulfan/Cyclophosphamide as Therapy for Hematologic Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Hematopoietic reconstitution measured daily during transplant
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving busulfan, cyclophosphamide, and filgrastim together with peripheral stem cell transplantation from a sibling donor works in treating patients with hematologic cancer.
详细描述
OBJECTIVES:
- Determine the safety and feasibility of using allogeneic peripheral blood progenitor cell infusions obtained from normal histocompatible sibling donors for reconstituting bone marrow and immunologic function when given after high-dose busulfan/cyclophosphamide in patients with a hematologic malignancy.
- Determine the efficacy of this treatment in these patients.
- Determine the ability to mobilize hematopoietic progenitor cells from normal donors given filgrastim (G-CSF) by determining the hematopoietic progenitor cell content of allogeneic peripheral blood progenitor cell collections.
- Determine the incidence of engraftment failures in these patients.
- Determine the incidence of severe acute graft-versus-host disease in these patients.
OUTLINE: Patients receive high-dose oral busulfan every 6 hours on days -8 to -5, cyclophosphamide IV twice a day on days -4 and -3, and cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses (allogeneic only). Allogeneic peripheral blood progenitor cells IV are administered on day 0.
Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover.
Patients are followed every month for 2 months, every 3 months for 6 months, and then every 6 months until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically diagnosed:
- •Acute myeloid leukemia in first, second, or third complete remission or first or second early relapse
- •Acute lymphoblastic leukemia in first, second, or third complete remission or first or second early relapse
- •Hodgkin's lymphoma in second or third remission or first, second, or third relapse, or refractory
- •Non-Hodgkin's lymphoma in second or third remission or first, second, or third relapse, or refractory
- •Multiple myeloma and plasma cell leukemia in second or third remission or first, second, or third relapse, or refractory
- •Myelodysplastic syndrome deemed suitable for allogeneic bone marrow transplantation
- •No symptoms or signs of CNS involvement and CNS is disease free on lumbar puncture and brain CT scan
- •No active meningeal cancer
- •PATIENT CHARACTERISTICS:
- •4 to 55 (4 to 60 if donor is identical twin)
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •SGOT/SGPT less than 3 times normal
- •Bilirubin less than 2.0 mg/dL
- •Creatinine less than 2.1 mg/dL
- •Creatinine clearance at least 60 mL/min (no greater than 1.5 times normal for children under 40 kg)
- •Cardiovascular:
- •No uncontrolled hypertension
- •No uncontrolled congestive heart failure
- •No active angina pectoris requiring nitrates
- •At least 6 months since prior myocardial infarction
- •No major ventricular arrhythmia
- •Left ventricular ejection fraction at least 45% on MUGA
- •No severe or symptomatic restrictive or obstructive lung disease
- •FEV_1 greater than 50% of predicted
- •DLCO greater than 50% of predicted
- •Neurologic:
- •No severe central or peripheral neurologic abnormality
- •Must have HLA-A,B,C,D/DR identical sibling age 4 to 65, in good health
- •No insulin-dependent diabetes mellitus
- •No major thyroid or major adrenal dysfunction
- •No active infection
- •No other active malignancy
- •Not pregnant
- •HIV negative
- •HTLV-I and HTLV-II negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No excessive anthracycline exposure, unless endomyocardial biopsy shows less than grade 2 drug effect and cardiac scan shows at least 50% ejection fraction
- •At least 1 year since prior autologous bone marrow or peripheral blood progenitor cell transplant or allogeneic bone marrow transplant
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy
- •No prior excessive carmustine and bleomycin
- •Endocrine therapy:
- •Not specified
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Hematopoietic reconstitution measured daily during transplant
时间窗: at months 2, 4, 7, and 10, and then every 6 months until disease progression
次要结局
未报告次要终点