A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (Sequential High Dose Cytosine Arabinoside and Mitoxantrone) Versus Standard Double Induction for Initial Chemotherapy of Adult Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 32
- 主要终点
- Overall response rate, aiming at a 15% increase in the CR/PR rate by S-HAM induction versus conventional double induction [TAD - HAM for younger patients, HAM (- HAM) for elderly patients].
研究概览
简要总结
Evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed AML (except acute promyelocytic leukemia) according to the WHO classification including patients with secondary AML and AML after preceding hematologic disorders
- •Age 18 years or older
- •Informed consent. Before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study.
排除标准
- •Acute promyelocytic leukemia (APL)
- •Previous or concurrent malignancies other than AML
- •Previous treatment with colony-stimulating factors, interleukins or interferons
- •Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®)
- •Antibody-based or cell-based immunotherapies
- •Respiratory insufficiency with pO2 <60 mmHg
- •Heart failure NYHA III° or IV°
- •Elevated creatinine >2.0 mg/dl
- •Elevated bilirubin >2.0 mg/dl
- •Pregnancy or lactation
- •Females without adequate contraception
- •Known HIV and/or hepatitis C infection
- •Severe neurologic or psychiatric disease
- •Psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study
- •Concerns for subject's compliance with the protocol procedures
- •Lack of willingness to record and circulate personal disease-related informations defined in the study protocol
研究组 & 干预措施
S-HAM
S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)
干预措施: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin (Drug)
TAD-HAM (younger) or HAM-HAM (elderly)
is TAD-9 - HAM for younger patients (with 2 mandatory induction cycles) and HAM (- HAM) for the elderly patients with the second HAM cycle only applied in the case of inadequate blast clearance (> 5%) in the day 16 bone marrow aspirate
干预措施: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin (Drug)
结局指标
主要结局
Overall response rate, aiming at a 15% increase in the CR/PR rate by S-HAM induction versus conventional double induction [TAD - HAM for younger patients, HAM (- HAM) for elderly patients].
时间窗: 8 years
次要结局
未报告次要终点
研究者
Prof. Dr. Wolfgang Hiddemann
Director of the Department of Medicine III
Ludwig-Maximilians - University of Munich