Randomized Prospective Phase II Clinical Trial Using Post-Transplantation Cyclophosphamide for Prevention of GVHD in Haploidentical and HLA-9/10 Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 2 期
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD
研究概览
简要总结
The primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched unrelated donor (MMUD).
It will use a Phase II, multicenter, prospective, randomized clinical trial.
By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients need to be recruited in each arm, for a total of 184 patients.
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
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a hematological malignancy requiring a HSCT and at least in partial response ie a) Acute Leukemia in complete remission, b) Myelodysplastic syndromes with less than 20% marrow, c) Myeloproliferative syndromes with less than 20% bone marrow blasts, d) Non Hodgkin Lymphoma (NHL), Hodgkin's disease, chronic lymphocytic leukemia at least in partial response, e) Myeloma at least in partial response.
- •Without HLA matched related or unrelated donor
- •Identification of a possible HLA-9/10 MMUD and a possible haplo-identical donor.
- •Having read and understood the information letter and signed the informed consent
- •With health insurance coverage
排除标准
- •Organic or psychiatric disease, non related to the hematological malignancy, contraindicating the transplant.
- •Performance Scale by the Eastern Cooperative Oncology Group (ECOG)> 2
- •Severe uncontrolled infection
- •Cardiac contraindication of post-transplant Cy (coronary insufficiency, ejection ventricular fraction <50%)
- •Aspartate transaminase (AST) and alanine transaminase (ALT) > 2.5 N, creatinine > 150 mmol/L (except if related to malignancy)
- •Previous active cancer in the last two years, except basal cell skin cancer and in situ carcinoma of the cervix
- •Childbearing age woman refusing contraception
- •Patients who did not accept the follow-up planned by the protocol
- •Positive serology for HIV or Human T-Lymphotropic Virus (HTLV)-1, 2, or active viral infection by the Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
- •Pregnant woman (positive β-HCG) or during lactation
- •Adult patient on guardianship, or safeguard justice
研究组 & 干预措施
HLA-9/10 MMUD group
干预措施: transplant from a non related donor (Procedure)
Haplo-identical group
干预措施: transplant from a haplo-identical donor (Procedure)
结局指标
主要结局
Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD
时间窗: 2 year
次要结局
- 100 day engraftment(day 100)