Azacitidine Compared to Conventional Chemotherapy in Consolidation of Elderly Patients (65 Years or Older) With AML in First Complete Remission
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Leukemia free survival
研究概览
简要总结
The purpose of this study is to determine whether Azacitidine consolidation is superior to standard DA consolidation treatment of acute myeloid leukemia in first complete remission in elderly patients.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects >65 years of age at the time of signing the informed consent form
- •A confirmed diagnosis of AML according to the 2008 WHO classification
- •This includes: Bone marrow aspirate with a good clot or biopsy for morphology, flow cytometry, cytogenetic analysis, and in case of normal cytogenetics, molecular genetic analyses including FLT3-ITD, NPM-1 and CEBP A
- •Bio-banking of leukemic cells at diagnosis performed (according to guidelines of the Swedish National AML biobank).
- •A documented CR or CRp achieved after one or two induction courses.
排除标准
- •Subjects who are not considered to be candidates to complete the consolidation therapy due to medical or psychological reasons.
- •Subjects who have taken any investigational drugs or participated in an interventional clinical trial within 30 days prior to screening.
- •Patients with acute promyelocytic leukemia
- •Patients with t(8;21) or inv(16)
- •CNS leukemia
- •Patients with a previous diagnosis of MDS, i.e. AML preceded by a diagnosed MDS
- •Subjects who are candidates for allogeneic stem cell transplantation (SCT)
- •Another cancer diagnosis with a life expectancy of less than two years
研究组 & 干预措施
Azacitidine
Azacitidine 75mg/m2/d subcutaneously once daily for 5 days given every 5:th week for 8 cycles.
干预措施: Azacitidine (Drug)
DA
Two courses of DA in accordance with the Swedish National treatment program (reduced doses):
In case one induction course was given:
First consolidation course: daunorubicin 45 mg/m2 x 1 (iv infusion) day 1-3 and cytarabine 1000 mg/m2 x 2 (iv infusion) day 1-4.
Second consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5.
In case two induction courses were given:
First consolidation course: daunorubicin 45 mg/m2 x 1( iv infusion) day 1-2 and cytarabine 200 mg x 2 (fixed dose sc injection) day 1- 5.
Second consolidation course: cytarabine 200mg x 2 (fixed dose sc injection) day 1-5.
干预措施: DA (Drug)
结局指标
主要结局
Leukemia free survival
时间窗: One year
次要结局
- Treatment related morbidity and mortality(Two years)
- Overall survival(Two years)
- Severe Adverse Events (SAE)(Two months after the last course of consolidation)
- Number of participants with AE grade 3 or more(Until two months after the last course of consolidation)
- Number of days admitted in hospital(12 months from start of consolidation treatment)
- Number of consolidation courses actually given within the study(One year)
- Quality of life(Until 24 months from start of consolidation treatment)
研究者
Stefan Deneberg
M.D, Ph.D.
Karolinska University Hospital