Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 53
- 主要终点
- Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant
研究概览
简要总结
RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an peripheral stem cell transplant for chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of autologous peripheral blood stem cell transplantation in patients with chronic lymphocytic leukemia treated with cyclophosphamide and total-body irradiation.
Secondary
- Determine the safety, feasibility, and efficacy of combination therapy comprising dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) and filgrastim (G-CSF) mobilization in patients treated with this regimen.
- Determine the efficacy of ex-vivo graft purging in patients treated with this regimen.
- Determine the incidence of complete clinical and molecular remissions in patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: filgrastim (Biological)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: carmustine (Drug)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: cyclophosphamide (Drug)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: cytarabine (Drug)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: dexamethasone (Drug)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: etoposide (Drug)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: fludarabine phosphate (Drug)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: melphalan (Drug)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: bone marrow ablation with stem cell support (Procedure)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: peripheral blood stem cell transplantation (Procedure)
High dose therapy + autologous PBSCT
- Cytoreductive treatment: (preferentially) FC (2-4 cycles)
- Mobilization: Dexa-BEAM + G-CSF (1-2 cycles)
- Myeloablation:
fractionated TBI (e.g. 6x2Gy) + Cyclophosphamide (2 x 60 mg/kg; d -4 to -3) 4. autologous peripheral blood stem cell transplantation (PBSCT) (d 0)
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant
Feasibility of PBSCT as measured by > 50% of included patients proceeding to transplant
次要结局
- Safety of mobilization comprising dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) as measured by a treatment-related mortality of < 5% before transplant phase
- Efficacy of Dexa-BEAM mobilization as measured by the amount of CD34+ cells > 4x10e6/kg at harvest
- Complete clinical remissions by NIH criteria at 3 months following transplant
- Molecular remissions by CDR3 PCR at 3 months following transplant
- Progression-free survival by NIH criteria at 5 years from study entry