Randomized Study to Compare Post Bone Marrow Transplant Cyclophosphamide With the Combination of Methotrexate Plus Calcineurin Inhibitor for Graft Versus Host Disease Prophylaxis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
研究概览
简要总结
The purpose of this study is to determine whether cyclophosphamide post bone marrow transplant increases the rate of patients alive, in remission and without immunosuppression, one year after transplant, when compared with the combination of methotrexate and calcineurin inhibitor
详细描述
We propose a study in which 150 patients will receive graft versus host disease prophylaxis with cyclophosphamide 50 mg/kg on day +3 and day +4 after bone marrow transplantation, and 150 patients will receive the usual combination of methotrexate and calcineurin inhibitor. The study was designed to last for 4 years. The primary endpoint is the rate of patients alive, in remission and without immunosuppression, one year after transplant. The assignment for each arm of the study will be done through simple randomization.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman 18 to 60 years of age.
- •The patient should have a HLA matched donor
- •The patient must need a bone marrow transplant for a malignant disease (Acute leukemia, myelodysplastic syndrome, myeloproliferative disease or myelodysplastic/myeloproliferative disease)
- •Patients want to participate in the study, and able to give informed consent.
排除标准
- •Previous auto o allogeneic hematopoietic stem cell transplant
- •Performance Status >2 (ECOG).
- •Pregnancy
- •HIV positive
- •Active Infection
- •Cardiac disease with ejection fraction < 45%
- •Lung disease with FEV1, FVC ou DLCO <50% of predicted values.
- •Renal Insufficiency with creatinine clearance < 60 ml/minute.
- •Liver disease with bilirubin levels > twice the reference value or ALT or AST > three times the normal reference.
研究组 & 干预措施
Arm A
Graft versus host disease prophylaxis will be done with cyclophosphamide 50 mg/kg on day +3 and day +4
干预措施: ARM A Cyclophosphamide (Drug)
Arm B
In this arm, patients will receive a combination of methotrexate and a calcineurin inhibitor as graft versus host disease prophylaxis
干预措施: ARM B Calcineurin inhibitor and methotrexate (Drug)
结局指标
主要结局
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
时间窗: one year
The rate of patients alive, in remission and without immunosuppression, one year after bone marrow transplantation.
次要结局
- Cumulative incidence of chronic graft versus host disease, one year after bone marrow transplantation(one year)
研究者
Paulo Vidal Campregher
MD
Hospital Israelita Albert Einstein