EUCTR2007-006475-36-GB进行中(未招募)1 期
Phase ll Study of the Adjunctive Use of Azacitidine in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Acute Myeloid Leukaemia - RICAZA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 40
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
入选标准
- •Patients >18 years and in whom allogeneic transplantation using a myeloablative conditioning regimen is contra-indicated.
- •1) Diagnosis
- •Patients who fulfil WHO criteria for AML
- •2) Patients with a HLA identical sibling or suitable matched unrelated donor. Suitable match equals no greater than a single allele mismatch and considered fit for reduced intensity transplant.
- •3) Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- •4) Be willing and able to comply with the protocol for the duration of the study.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •1) Patients with contraindications to receiving transplant conditioning therapy or Azacitidine.
- •2) Pregnant or lactating women or adults of reproductive potential not willing to use appropriate medically approved contraception during the trial and for 12 months post study.
- •3) Any co-morbidity that in the investigators opinion will affect the patients participation in this study.
研究者
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