A Randomized Pilot Trial Comparing Anti-Thymocyte Globulin (ATG) With ATG Plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis Against Acute and Chronic Graft Versus Host Disease (GVHD)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 9
- 主要终点
- Registration of 80 patients within twenty four months
研究概览
简要总结
A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.
详细描述
Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is aged ≥ 16 and deemed medically fit per investigator for protocol
- •The participant has either acute myeloid leukemia in 1st or 2nd complete remission (CR), or has myelodysplastic syndrome
- •The participant will receive a blood progenitor cell graft ("HPC, Apheresis")
- •The participant has a related or unrelated donor, who is fully MHC matched with the recipient at HLA-A, B, C and DRB
- •The participant meets the transplant centre's criteria for transplantation, using either myeloablative or reduced intensity conditioning.
- •The participant has good performance status (Karnofsky ≥60%)
- •The participant is able to understand and sign the informed consent form
- •Ability and willingness to comply with study procedures and schedule, in the Investigator's opinion.
- •The participant is receiving their first transplant
排除标准
- •The participant is HIV antibody positive
- •The participant has a hypersensitivity to rabbit proteins or Thymoglobulin® pharmaceutical excipients, glycine or mannitol.
- •The participant has active or chronic infection (i.e. infection requiring oral or IV therapy)
- •The participant (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment
- •The participant (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3
- •The participant (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant3
- •The participant has urinary outflow obstruction
- •The participant is in poor condition (determined per institutional guidelines)
- •The participant has acute leukemia in relapse
- •The participant has myelodysplastic syndrome with > 10% marrow blasts
- •The participant is having their second transplant
- •The participant is taking T-cell antibody prophylaxis (anti-CD52)
- •The participant is receiving a cord blood graft or T-cell depleted grafts
- •The participant has mixed phenotype acute leukemia
- •The participant has prior malignancies, except resected nonmelanoma or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously must be reviewed and approved by the sponsors.
- •The participant is in complete remission with incomplete recovery (CRi)
研究组 & 干预措施
ATG
Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1).
干预措施: Anti-Thymocyte globulin (rabbit) (Drug)
ATG/PTCy
Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.
干预措施: Cyclophosphamide (Drug)
ATG/PTCy
Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4.
干预措施: Anti-Thymocyte globulin (rabbit) (Drug)
结局指标
主要结局
Registration of 80 patients within twenty four months
时间窗: 24 months
Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)
次要结局
- CRFS(27 months)
- GRFS(27 months)
- Cost of study(27 months)
- Survival(27 months)
- Complete data collection(27 months)