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临床试验/JPRN-jRCTs031190075
JPRN-jRCTs031190075招募中2 期

Safty and efficacy of preparative regimens combined with thrombomodulin-alfa in allogeneic stem cell transplantation in elderly patients with hematological diseases~Examine the safety of combination of preparative regimens and thrombomodulin-alfa ~ - rTM001 study

Miyakoshi Shigesaburo0 个研究点目标入组 20 人开始时间: 2019年8月14日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
20

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
>= 65age old 至 < 80age old(—)
性别
All

入选标准

  • 1.Over 65 yo with hematological malignanncies who have no curable treatment with comventional therapy
  • except allogeneic stem cell transplantation
  • 2. Patines scheduled allogeneic stem cell transplantation including bone marrow transplantatin or
  • peripheral blood stem cell transplantation or umbilical cord blood transplantain
  • 3. Patients' Age between 65 yo up to 80 yo
  • 4.Written informed consent

排除标准

  • 1. Eastern Cooperative Oncology Group Performance status over 2
  • 2. Under 50% ejection fraction by echocardiography
  • 3. Abnomal ECG including ischemic change or arrhythmia to need treatment
  • 4. Under 93% sO2 under room air
  • 5. Serum creatinine over 2.0 mg per dL
  • 6. Total bilirubin over 1.6 mg per dL or AST over twice maximum normal level
  • 7. Adult T cell leukemia
  • 8. Concerned about following diseases
  • i) Intracranial bleeding, lung bleeding,and gastrointestinal bleeding
  • ii) Allergy to thrombomodulin-alpha
  • 9. Patient who judged it to be inappropriate

研究者

发起方
Miyakoshi Shigesaburo

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