Use of Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies, a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).
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
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women of Any Age
- •Indication for an HSCT without matched sibling donor
- •Have a matched unrelated donor (HLA 10 x 10 or 9 x 10)
- •Hematological malignancy
排除标准
- •Acute leukemias not in complete response (that is > 5% blast in the bone marrow)
- •Chemorefractory lymphoproliferative disease
- •Active uncontrolled infection
- •HCT-CI > 3
- •Severe organic disfunction (heart ejection fraction < 45%, glomerular filtration rate < 50 mL.hour, pulmonary DLCO < 50%)
- •Previous allogeneic bone marrow transplantation
- •Contraindication to cyclophosphamide or ATG
研究组 & 干预措施
Post Cyclophosphamide
Cyclophosphamide 50 mg/Kg on days +3 and +4 AND Calcineurin Inhibitor from day +5 AND Mycofenolate Mofetil from day +5 until day +35
干预措施: Cyclophosphamide (Drug)
Thymoglobulin (ATG)
Thymoglobulin (ATG) total dose 5 mg/Kg from day -4 until day -1 AND Calcineurin Inhibitor from day +5 AND Methotrexate on days +1, +3, +6 and +11
干预措施: ATG (Drug)
结局指标
主要结局
Overall Survival
时间窗: 4 years
Time to last follow-up or death
次要结局
- Progression free survival(4 years)
- Acute Graft Versus Host Disease(4 years)
- Chronic Graft Versus Host Disease(4 years)
- Treatment Related Mortality(4 years)
研究者
Andreza Alice Feitosa Ribeiro
Assistant Physician specialist in Hematopoietic Stem Transplantation, Principal Investigator
Hospital Israelita Albert Einstein