NCT06418776招募中3 期
A Prospective Multicenter Randomized Clinical Trial on the Treatment of Patients With Refractory or Early Relapses of Acute Myeloid Leukemia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Event-free survival of patients with R/R AML depending on the use of high or low intensity therapy exposure before alloHSCT
研究概览
简要总结
The primary objective is to evaluate the efficacy and toxicity of high versus low intensity therapy options in patients with refractory forms and early relapses of acute myeloid leukemia (R/R AML) who are scheduled for allogeneic hematopoietic stem cell transplantation (alloHSCT).
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
- •Age ≥ 18 years;
- •Primary refractory AML;
- •Early relapsed AML;
- •A signed informed consent to participate in the study.
排除标准
- •Late relapsed AML;
- •Isolated extramedullary relapse;
- •MRD relapse without development of bone marrow relapse of AML;
- •Acute promyelocytic leukemia;
- •Previous refractoriness or loss of response during ongoing venetoclax therapy;
- •Previous alloHSCT;
- •Pregnancy and/or lactation period;
- •Refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study;
- •Lack of signed informed consent to participate in the study;
- •Failure of the subject to follow the study protocol;
- •Participation in any other clinical trial;
- •Uncontrolled infectious complications;
- •ECOG ≥ 3;
- •History of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years;
- •Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (according to the CKD-EPI Creatinine Equation);
- •Severe cardiac pathology:
- •uncontrolled arterial hypertension;
- •stable angina III-IV functional classes;
- •unstable angina and/or myocardial infarction less than 6 months before inclusion in the study;
- •heart failure stages IIb-III, NYHA functional classes III-IV
- •uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities.
- •Cirrhosis classes B-C according to the Child-Pugh classification
- •Increased liver function tests above the following values:
- •Total bilirubin > 1,5 above the normal range;
- •AST, ALT > 10 above the normal range.
- •Major surgical interventions underwent less than 14 days before inclusion in the study.
研究组 & 干预措施
Intensive arm
Active Comparator
Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to intensive chemotherapy courses
干预措施: Intensive therapy (Other)
Low-intensive arm
Active Comparator
Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to low intensity courses
干预措施: Low intensity therapy (Other)
结局指标
主要结局
Event-free survival of patients with R/R AML depending on the use of high or low intensity therapy exposure before alloHSCT
时间窗: 2 years
Evaluation method: Kaplan-Meier curves and log-rank test, censored for transplantation
次要结局
- Statistics on discontinued participation in the protocol and premature withdrawal from the study(2 years)
- Probability of achieving a response (CR, CR with incomplete hematological recovery, morphologic leukemia- free state, partial remission) in patients with R/R AML, depending on the use of high or low intensity treatment regimens(3 months)
- Probability of achieving CR in patients with R/R AML, depending on the use of high or low intensity treatment regimens(3 months)
- Cumulative incidence of alloHSCT in patients with R/R AML, depending on the use of high or low intensity treatment regimens(2 years)
- Toxicity of high versus low intensity regimens(3 months)
- OS over the entire duration of the study, including follow-up after alloHSCT(2 years)
- EFS of patients with R/R AML depending on the use of high or low intensity regimens, regardless of alloHSCT(2 years)
- RFS in patients with R/R AML when achieving remission before alloHSCT, depending on the use of high or low intensity treatment regimens(2 years)
- Relapse incidence in patients with R/R AML when achieving remission before performing alloHSCT, depending on the use of high or low intensity treatment regimens(2 years)
研究者
Elena N.Parovichnikova
General director of National Medical Research Center for Hematology
National Research Center for Hematology, Russia
研究点 (1)
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