A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation
研究概览
简要总结
The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria
- •CR 1 with poor risk features
- •CR 2, or higher order CR
- •Acute lymphoblastic leukemia (ALL) with one of the following criteria
- •CR 1 with poor risk features
- •CR 2, or higher order CR
- •Myelodysplasia, RAEB I
- •Donor has been identified
- •Age ≤ 65 years.
- •Performance Status 0-1.
排除标准
- •Patients relapsing <6 months after autologous SCT are not eligible.
- •Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
- •Non-pregnant and non-nursing
研究组 & 干预措施
1
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
干预措施: Total Body Irradiation (Radiation)
1
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
干预措施: Thiotepa (Drug)
1
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
干预措施: Fludarabine (Drug)
1
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
干预措施: Rabbit ATG (Biological)
2
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
干预措施: Total Body Irradiation (Radiation)
2
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
干预措施: Thiotepa (Drug)
2
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
干预措施: Fludarabine (Drug)
2
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
干预措施: Rabbit ATG (Biological)
2
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
干预措施: Palifermin (Drug)
结局指标
主要结局
Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation
时间窗: thru 6 months after transplant
To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.
次要结局
- Time to Platelet Engraftment(Transplant (Day 0) up to 1 year)
- Regimen-related Toxicity(Up to 1 year)
- Time to Neutrophil Engraftment(Transplant (Day 0) up to 1 year)
- Chronic Graft vs. Host Disease (GvHD)(Up to 1 year)
- Acute Graft vs. Host Disease (GvHD)(Up to 1 year)
- Frequency of Infection(Day 0 through 1 year post transplantation)
研究者
Sherif S. Farag
Lawrence H. Einhorn Professor of Oncology
Indiana University