NCT02507479Unknown2 期
Phase II Trial of Fludarabine Combined With Intravenous Thiotepa and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies Including Multiple Myeloma, Non Hodgkin's, Hodgkin Lymphoma and CLL
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.
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 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age less than physiologic 68 years.
- •Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:
- •MM; patients relapsing after autologous transplant or with high-risk cytogenetic abnormalities
- •Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
- •Follicular lymphoma; failure of at least one prior regimen
- •CLL; failure of prior therapy which includes Fludarabine combinations or 17p- cytogenetic abnormality
- •Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB) typing. The goal is to transplant > 3 x 106 CD34+ cells per kg body weight of the recipient
- •Patients must sign written informed consent.
- •Adequate birth control in fertile patients.
排除标准
- •Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- •Creatinine > 2.0 mg/dl
- •ECOG-Performance status > 2
- •Uncontrolled infection
- •Pregnancy or lactation
- •Abnormal lung diffusion capacity (DLCO < 40% predicted)
- •Severe cardiovascular disease
- •CNS disease involvement
- •Pleural effusion or ascites > 1 liter
- •Known hypersensitivity to Fludarabine or treosulfan
- •Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
研究组 & 干预措施
thiotepa
Experimental
Thiotepa 5-10 mg/kg/d x 2 days
干预措施: Thiotepa (Drug)
结局指标
主要结局
disease-free survival
时间窗: 2 years after transplantation
The percentage of patients alive without disease recurrence 2 years after transplant
次要结局
- treatment-related mortality(2 years after transplantation)
- graft versus host disease(1 year after transplantation)
- relapse(2 years after transplantation)
研究者
研究点 (1)
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