EUCTR2016-002129-12-FR进行中（未招募）1 期
A randomized phase IIb study of cyclophosphamide (Cy) versus anti-thymocyte globulin (ATG) for the prophylaxis of graft-versus-host disease (GVHD) after reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation - ATG-CY GVHD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients aged between 18 and 65 years
- •- Presence of a hematologic malignancy for which a reduced-intensity conditioning allo-SCT is indicated (eligibility criteria for RIC allo-SCT include at least one of the following parameters: (i) patient age older than 50 years; (ii) heavily pre-treated patients who received an autologous hematopoietic SCT (auto-SCT) or with more than 2 lines of chemotherapy before allo-SCT ; and (iii) patients with poor performance status because of significant medical comorbidities as described by Sorror et al.
- •- Karnofsky index ? 70%
- •- Availability of a sibling or unrelated stem-cell donor (10/10-HLA matched unrelated donor)
- •- Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment
- •- Written informed consent.
- •- Affiliation to a social security system (recipient or assign)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 88
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Creatinine clearance less than 30 mL/min
- •- Bilirubin or amino-transferases above 3X upper normal limit
- •- Cardiac ejection fraction less than 40%
- •- Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)
- •- Known hypersensitivity or contraindication to the use of post-transplant Cy and ATG
- •- Any circumstance that precludes the use of the drugs involved in the protocol
- •- Pregnancy or breast-feeding women
研究者
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