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临床试验/JPRN-jRCTs051180119
JPRN-jRCTs051180119招募中2 期

Study of Efficacy and Safety of Non-myeloablative Haploidentical Stem Cell transplantation using post-transplant cyclophosphamide for refractory hematological malignancies. - Haplo-HSCT-RIC

Okamura Atsuo0 个研究点目标入组 23 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
23

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 <= 65age 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, <=65 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

发起方
Okamura Atsuo

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