NCT06557421招募中2 期
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first.
研究概览
简要总结
The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are:
- Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival.
- Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy.
Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria.
Participants will:
- Stop VEN-DASA treatment
- Be closely monitored by regular evaluation of the disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female/Male ≥ 18 years of age;
- •Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;
- •VEN-AZA given as first-line treatment;
- •Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses;
- •Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh);
- •Absence of detectable minimal residual disease (MRD) performed locally (i.e. MRDneg defined as MCF MRD <0.1% of CD45 expressing cells with the target immunophenotype in bone marrow, or NPM1 or RUNX1-RUNX1T1 or CBFB-MYH11 MRD copy numbers <0.1% in the blood);
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- •Affiliated to the French Social Security or beneficiary of such a health Insurance;
- •Signed informed consent.
- •Non inclusion Criteria:
- •VEN-AZA given as salvage therapy;
- •Prior allogeneic stem cell transplant;
- •Discontinuation of treatment because of absence or loss of response;
- •Patient in emergency situation or unable to give consent;
- •Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.
排除标准
- 未提供
研究组 & 干预措施
VEN-AZA de-escalation
Experimental
VEN-AZA de-escalation
干预措施: Venetoclax (Drug)
VEN-AZA de-escalation
Experimental
VEN-AZA de-escalation
干预措施: Azacitidine (Drug)
结局指标
主要结局
Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first.
时间窗: 24 months
次要结局
- Absolute duration of hematologic response, defined as the time from inclusion to relapse or death.(24 months)
- Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death.(24 months)
- Cumulative incidence of relapse, defined as the probability of relapse over time.(24 months)
- Overall survival, defined as the time from inclusion (VEN-AZA de-escalation) to death.(24 months)
- Second complete remission occurence.(24 months)
- Time to second remission, defined as the time between date of treatment re initiation and complete remission.(24 months)
- Hospitalization rate associated with VEN-AZA de-escalation.(24 months)
- Transfusion occurrence associated with VEN-AZA de-escalation.(24 months)
- Grade 3-4 adverse events occurence associated with VEN-AZA de-escalation.(24 months)
- Correlation between age and duration of response and survival after VEN-AZA de-escalation.(24 months)
- Correlation between FAB classification and duration of response and survival after VEN-AZA de-escalation.(24 months)
- Correlation between cytogenetic and molecular alterations and duration of response and survival after VEN-AZA de-escalation.(24 months)
- Correlation between number of prior VEN-AZA cycles and duration of response and survival after VEN-AZA de-escalation.(24 months)
研究者
研究点 (1)
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