DRKS00003225招募中3 期
Randomized phase III study comparing the OSHO arm to the standard therapy arm of Geman AML Intergroup. Randomized comparison of Cytarabine and Mitoxantrone versus Fludarabine, Cytarabine, Mitoxantron and G-CSF treatment in patients not in remission after the first induction chemotherapy. Randomized comparison between one or two chemotherapy consolidation courses before autologous or allogeneic human stem cell transplantation in adult patients with AML under the age of 60 years. - AML 2002 #061
niversitätsklinikum LeipzigHämatologie/Onkologie0 个研究点目标入组 730 人开始时间: 2011年8月16日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 730
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •> age >=18 years and <=60 years
- •--> newly diagnosed acute myeloid leukemia as defined by new WHO classification
- •--> Myelodysplastic Syndrome RAEB-T according to FAB-classification (blasts in bone-marrow 20-30%)
- •--> de novo AML, secondary AML (patients with a history of myelodysplasia or other antecedent hematologic disorder for at least 6 months or therapy-related AML after previous exposure to cytotoxic drugs or radiotherapy)
- •-->patients written informed consent
排除标准
- •--> AML FAB M3 - acute promyelocyte leukemia
- •--> involvement in other clinical trials
- •--> contraindication to intensive chemotherapy:
- •--> Renal failure not AML-related
- •--> Hepatic insufficiency not AML-related
- •--> Cardiac insufficiency NYHA III + IV
- •--> Uncontrolled infection
- •--> Pregnancy
- •--> Karnofsky-performance-score 10
- •--> Secondary malignancies
- •--> Severe, decompensated metabolic disorders
- •--> mental impairment with inability to give consent
研究者
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