CTRI/2014/06/004676招募中2 期
Phase II trial to study if the addition of fludarabine to the standard regimen of Anti-thymocyte globulin (ATG) and cyclosporine will improve remission rates in patients with severe and very severe aplastic anemia (SAA/VSAA)
INVESTIGATOR INITIATED STUDY0 个研究点目标入组 20 人开始时间: 待定最近更新:
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
入选标准
- •Adult patients with SAA or VSAA who give consent for the trial [Definition of SAA is as per Camitta et al â?? Bone marrow cellularity < 25% with 2 out of the following 3 criteria â?? Neutrophils < 0.5 x 109/L, Platelet count < 20 x 109/L, reticulocyte count < 20 x 109/L]; VSAA defined as Neutrophils < 0.2 x 109/L with all other criteria of SAA
排除标准
- •1. Children 15 years of age
- •2. Patients with any abnormalities suggestive of congenital bone marrow failure syndromes such as Fanconiâ??s anemia or Dyskeratosis congenita
- •3. Patients who had active infection requiring admission within 2 weeks prior to ATG
- •4. Pregnancy
- •5. Creatinine 1.4 mg/dl
- •6. Prior history of treatment with ATG
- •7. Seropositivity for HIV, Hepatitis B or C
- •8. Any other significant co-morbidities that make death likely in the next 4 weeks.
研究者
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