IRCT20140818018842N25招募中3 期
Comparison of Myeloablative versus Reduced-Intensity conditioning regimen before Hematopoietic Cell Transplantation in Measurable Residual Disease negative, 50 years or older patients with Acute Myeloid Leukemia, Myelodysplastic Syndromes and Acute Lymphoblastic Leukemia: A phase III Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 84
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
- 50 years 至 65 years（—）
- 性别
- All
入选标准
- •Patients from 50 to 65 years old
- •Patients with diagnosis of Myelodysplastic Syndromes , Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia who are Measurable Residual Disease negative pre-transplant within 30 days of enrollment.
- •Patient and donor are allowed to be a full match (8/8), or at least Human Leukocyte Antigens (HLA)-A, -B, -C and DRB1 matched.
- •Cardiac function: Ejection Fraction = 40%
- •Hepatic function: total bilirubin and Aspartate transaminase (AST) and alanine aminotransferase (ALT) = 2,5 x the upper limit of normal
- •Pulmonary function: Forced expiratory volume (FEV1) = 50%
- •Renal function: creatinine clearance > 40 mL/min based on the Cockroft-Gault formula
- •Hematopoietic Cell Transplantation-specific Comorbidity Index (HCT-CI) score <4
- •Signed informed consent.
排除标准
- •Prior allogeneic stem cell transplantation
- •Symptomatic coronary artery disease
- •Karnofsky Performance Score < 70
- •Central nervous system involvement
- •Patients with uncontrolled bacterial, viral or fungal infection
- •Females who are pregnant or breastfeeding.
- •Patients seropositive for human immunodeficiency virus.
研究者
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