JPRN-jRCTs051180118招募中2 期
Study of Efficacy and Safety of Myeloablative Haploidentical Stem Cell transplantation using post-transplant cyclophosphamide for refractory hematological malignancies. - Haplo-HSCT-MAC
Okamura Atsuo0 个研究点目标入组 25 人开始时间: 2019年3月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 60age old（—）
- 性别
- All
入选标准
- •1. Hematopoietic malignant tumors suitable for hematopoietic stem cell transplantation
- •2. Disease status; remission phase or non-remission phase
- •3. Age; >=16 year-old, <=60 year-old
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 2
- •5. Adequate organ function:
- •a. Ejection fraction >=50%
- •b. T-Bil <= 2.0 mg/dl, AST and ALT <= 3 times of the high end of the normal range
- •c. CCr >= 30ml/min
- •d. SpO2 >=95% (room air)
- •6. No HLA-matched related donor
- •7. No HLA-matched unrelated donor
- •8. Written informed consent
排除标准
- •1.HIV antibody positivity
- •2.Active multiple primary cancers
- •3.Active infection
- •4.Pregnant, unwilling to practice contraception during the study, or lactating female
- •5.Hypersensitivity to agents used for conditioning and GVHD prophylaxis
- •6.Specific HLA antibody against donor HLA
- •7.Administration of anticancer drugs except the study protocol within 13 days before transplantation
- •8. Other, determination of the attending physician
研究者
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