MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a Phase II study following subjects proceeding with Treosulfan (36g/m2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg/kg, tacrolimus and MMF for GVHD prophylaxis.
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
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 2-75 years of age
- •≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (< 16 years) with appropriate organ criteria as below (in other inclusion criteria)
- •5/6 or 6/6 related donor, OR a 5-8/8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5/10) related donor
- •adequate liver (no decompensated liver failure, Child Pugh A, AST/ALT <5X ULN) and renal function (creatinine <2.0)
- •absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
- •DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement
排除标准
- •Pregnant or breastfeeding
- •Evidence of untreated/uncontrolled HIV infection
- •Untreated active serious infection
- •Active CNS malignancy
- •CML in blast crisis not in a complete remission by abnormal blast count.
- •Less than 3 months since prior myeloablative transplant
研究组 & 干预措施
Treo/Flu with PTCy
Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.
干预措施: Total Body Irradiation (Radiation)
Treo/Flu with PTCy
Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.
干预措施: Stem Cell Infusion (Biological)
Treo/Flu with PTCy
Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.
干预措施: Fludarabine (Drug)
Treo/Flu with PTCy
Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.
干预措施: Treosulfan (Drug)
Treo/Flu with PTCy
Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.
干预措施: Cyclophosphamid (Drug)
Treo/Flu with PTCy
Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.
干预措施: Tacrolimus (Drug)
Treo/Flu with PTCy
Subjects treated with Treosulfan and Fludarabine preparative regimen with TBI for AML and MDS patients followed by a related or unrelated donor stem cell infusion utilizing PTCy, tacrolimus and MMF as GVHD prophylaxis.
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Overall Survival
时间窗: Day 100
Evaluate rates of overall survival at 100 days after transplant.
次要结局
- Transplant Related Mortality(Day 100 and 1 year)
- Overall Survival(1 and 2 years)