Phase II Multicentric Trial Maintenance Therapy With 6 Monthly Revlimid® Cycles Alternated With 6 Monthly Vidaza® Cycles in First CR After Induction LIA Chemotherapy for Elderly Fit Patients With Poor Prognosis Acute Myeloid Leukemia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of a Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit Patients With Poor Prognosis Acute Myeloid Leukemia (AML).
The disease-free survival (DFS) of the patients included in this study will be compared to the ones of the two previously reported groups of patients treated with the same LIA induction therapy
详细描述
- The primary objective of this study will be to improve the DFS with an alternate schema combining azacitidine and lenalidomide in elderly fit patients with previously untreated AML and with high risk cytogenetics or secondary AML, who achieved either a complete remission after an LIA induction therapy
- The secondary objectives will be to determine the relapse incidence, overall survival, event free survival at 1 and 2 years of follow-up, toxicities of the treatment, incidence of infectious events.
- To define a gene expression and promoter methylation signatures associated with CR and absence of relapse when patients received azacitidine and lenalidomide. Gene promoter methylation and gene expression profiling will be performed at diagnosis, at CR, and after 2 courses of azacitidine and lenalidomide in order to give insight within the mechanisms involved by the use of these 2 drugs and to identify new epigenetic prognostic markers.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologically or histologically confirmed acute myeloid leukemia (AML) with :
- •At least 60 years of age and fit for intensive chemotherapy: PS <2 (ECOG)
- •Absence of significant co-morbidities
- •Less than 75 years* of age
- •LAM with high risk features (blasts > 20% in bone marrow)
- •Poor risk cytogenetics
- •Life expectancy > 1 month
- •Affiliated to social security regimen
- •No granulocytic sarcoma as sole site of disease
- •Able and willing to provide written and signed informed consent
排除标准
- •Total bilirubin > 2 times upper limit of normal
- •AST and ALT and/or alkaline phosphatase > 4 times upper limit of normal if not in relation with AML.
- •Factor V < 50% without DIC (Disseminated Intravascular Coagulation)
- •NYHA class III or IV congestive heart failure (Echo < 40%, LVEF < 50%),Unstable angina pectoris, Serious cardiac arrhythmia
- •Renal failure not related to AML: serum creatinin > 170 μmol/L or clearance of creatinin ≤ 50 mL/mn
- •Known HIV 1- HIV 2 positivity
- •Prior therapy with azacitidine or lenalidomide
- •Psychiatric illness or social situations that would preclude compliance with study requirements
- •Uncontrolled infection
- •Urgent chemotherapy for DIC, spontaneous tumoral lyse syndrome, leucostase without cytogentic results
- •Women who are pregnant or breastfeeding
- •Women who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy
- •Men who are unwilling or unable to use an acceptable method of birth control
研究组 & 干预措施
ARM A
maintenance study treatment: azacitidine sc 75 mg/m²/d (d1- d7) in first cycle: months 1,3,5,7,9 ,11 then lenalidomide 10mg/d (d1- d21) months 2,4,6,8,10,12
干预措施: azacitidine (Drug)
ARM B
maintenance study treatment: lenalidomide 10mg/d (d1- d21)in first cycle and months 1,3,5,7,9 ,11 then azacitidine sc 75 mg/m²/d (d1- d7) months 2,4,6,8,10,12
干预措施: Lenalidomide (Drug)
结局指标
主要结局
DFS
时间窗: 18 months
The primary objective of this study will be to improve the DFS with an alternate schema combining azacitidine and lenalidomide in elderly fit patients with previously untreated AML and with high risk cytogenetics or secondary AML, who achieved either a complete remission after an LIA induction therapy.
次要结局
- gene expression and promoter methylation signatures associated with CR(0)
- relapse incidence OS EFS Infectious events(until death)