KCT0007596招募中未知
A Prospective, Randomized, Pilot Study for Optimal Use of Red Cells in Transfusion in Patients with Acute Myeloid Leukemia Receiving Dose Intensive Chemotherapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •Newly diagnosed non-acute promyelocytic leukemia acute myeloid leukemia (AML) aged between 19 to 70 years old, undergoing cytarabine ± anthracycline chemotherapy were considered eligible for enrollment. The diagnosis of AML was made according to the World Health Organization (WHO) Classification of Hematopoietic Neoplasms, which requires identification of 20% or more leukemic blasts in the bone marrow. For induction therapy, either idarubicin 12mg/m2 for 3 days plus cytarabine 100mg/m2 for 7 days or daunorubicin 60 to 90mg/m2 for 3 days plus cytarabine 100mg/m2 for 7 days were used. For FMS-related tyrosine kinase 3 (FLT3) positive patients, midostaurin use was allowed. For consolidation therapy, high dose cytarabine (HDAC, 3g/m2 twice daily over 3 days) and intermediate dose cytarabine (IDAC 2g/m2 twice daily over 3 days) were used. Patients were stratified according to chemotherapy (i.e. induction versus HDAC versus IDAC).
排除标准
- •Patients with biphenotypic leukemias, relapsed/refractory disease or treatment history for previous hematologic disease were excluded. Those (1) with history of transfusion related adverse events, (2) on anticoagulation or antiplatelet therapy, (3) active bleeding, (4) with history of major bleeding events according to International Society on Thrombosis and Hemostasis (ISTH)20 and (5) with cardio-pulmonary disease requiring higher Hb target levels per attending physician’s decision were also excluded.
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