EUCTR2017-001308-31-PL进行中（未招募）1 期
A Polish Adult Leukemia Group (PALG) prospective, multicenter clinical trial to compare the efficacy of two standard induction therapies (DA-90 vs DAC) and two standard salvage regimens (FLAG-IDA vs CLAG-M) in AML patients = 60 years of age - PALG-AML1/2016
Polish Adult Leukaemia Group (PALG)0 个研究点目标入组 582 人开始时间: 2017年4月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 582
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
- 性别
- All
入选标准
- •INDUCTION:1.Acute myelogenous leukemia (=20% of blasts In bone marrow). 2. AML de novo or AML secondary to Myelodysplastic Syndrome or AML secondary to therapies or agents causing leukemia, with primary tumour in remission since at least 2 years. 3. Age =18 - =60 yrs at signing patient’s consent. 4. Clinical status enabling to conduct induction treatment (performance status ECOG = 2, HCT-CI =3 according to Sorror at al. ECOG = 2 HCT-CI =3 according to Sorror at al.
- •REINDUCTION: Resistant or relapsed AML, NR after 1 or 2 cycles of induction, PR after 2 cycles of induction, relapsed at any time of remisssion.
- •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 582
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Promyelocytic leukemia. 2. No patient’s consent. 3. Active neoplastic disease other than AML. 4. Heart diseases, NYHA 3-4. 5. Pregnancy. 6. Uncontrolled infection. 7. Active HIV or HB/CV infection.
研究者
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