Clofarabine-melphalan-alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
研究概览
简要总结
This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory acute myelogenous or lymphoid leukemia
- •Chronic myelogenous leukemia in accelerated phase or blast-crisis
- •Chronic myelogenous leukemia in second or subsequent chronic phase
- •Recurrent or refractory malignant lymphoma or Hodgkin's disease
- •Multiple myeloma at high risk for disease recurrence
- •Chronic lymphocytic leukemia, relapsed or with poor prognostic features
- •Other Myeloproliferative disorder (polycythemia vera, essential thrombocythemia, myelofibrosis) with poor prognostic features
- •Myelodysplastic syndromes (including PNH) with > 5% blasts
- •Zubroid performance status < 2 (See Appendix B)
- •Life expectancy is not severely limited by concomitant illness
- •Adequate cardiac and pulmonary function. Patients with decreased LVEF or PFTS will be evaluated by cardiology or pulmonary prior to enrollment on this protocol
- •Calculated Creatinine Clearance > 50 ml/min
- •Serum bilirubin 2.0 mg/dl, SGPT < 3x upper limit of normal
- •No evidence of chronic active hepatitis or cirrhosis
- •HIV-negative
- •Patient is not pregnant
- •Patient or guardian able to sign informed consent
排除标准
- •Clinical progression
研究组 & 干预措施
Treatment
干预措施: Melphalan (Drug)
Treatment
干预措施: Campath (Drug)
Treatment
干预措施: Stem Cell Transplant (Procedure)
Treatment
干预措施: Clofarabine (Drug)
结局指标
主要结局
Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
时间窗: Day 7 until Day 30
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
时间窗: Day 7 until Day 30
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
时间窗: Day 7 until Day 30
Toxicity was scored according to NCI/CTC version 3
Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation
时间窗: Day 7 until Day 30
Toxicity was scored according to NCI/CTC version 3
次要结局
- Relapse Rate(1 year)
- Overall Survival (OS)(1 year)
- Progression-free Survival (PFS)(1 year)
- Treatment-related Mortality (TRM)(1 year)