2024-514112-28-00招募中2 期
STOP VEN-IPC 2024-001 DE-ESCALATION STUDY EVALUATING VENETOCLAX AND AZACITIDINE DISCONTINUATION IN AML RESPONDING PATIENTS
Institut Paoli Calmettes5 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月28日最近更新:
适应症
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
- 5
- 主要终点
- The primary endpoint is 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 main objective is to evaluate the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Female/Male ≥ 18 years of age
- •Affiliated to the French Social Security or beneficiary of such a health Insurance
- •Signed informed consent
- •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 response defined as complete response (CR) or CR with incomplete hematologic recovery or CR with partial hematologic recovery
- •Absence of detectable minimal residual disease 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 <2% in the blood)
- •Females of childbearing potential (FCBP) must have a negative serum pregnancy test at the inclusion assessment. FCBP must also agree to utilize a highly effective method of contraception 6 months after stopping VEN-AZA treatment (according to VEN and AZA SmPCs). Male patients who are sexually active with a FCBP must agree to utilize a highly effective method of contraception 3 months after stopping VEN-AZA treatment (according to VEN and AZA SmPCs)
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
排除标准
- •VEN-AZA given as salvage therapy
- •Prior treatment with another drug in addition to VEN-AZA (for instance, triplet therapies with targeted therapies (i.e. IDH or FLT3 inhibitors) or investigational immunotherapy or new agents
- •Participation in a prior investigational study within 30 days prior to ICF’s signature or within 5 half-lives of the investigational product, whichever is longer.
- •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
结局指标
主要结局
The primary endpoint is 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.
The primary endpoint is 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.
次要结局
- Absolute duration of hematologic response, defined as the time from inclusion to relapse or death
- Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death
- Cumulative incidence of relapse, defined as the probability of relapse over time.
- Treatment-free remission, measured from inclusion to the date of morphologic or MRD relapse, treatment restart or death from any cause, whichever occurs first.
- Overall survival is defined as the time from inclusion (VEN-AZA de-escalation) to death
- In case of treatment re initiation, second complete remission, including complete remission/complete remission with incomplete hematologic recovery/complete remission with partial hematologic recovery rates. The time to remission will also be analyzed (defined as the time between date of treatment re initiation and complete remission)
- To assess quality of life: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire QLQ-C30
- Grade 3-4 adverse events (CTCAE v5.0)
- Hospitalization rate
- Transfusions
- To identify potential predictive factors associated with duration of response and survival after VEN-AZA de-escalation, age will be analyzed
- To identify potential predictive factors associated with duration of response and survival after VEN-AZA de-escalation, cytogenetic and molecular alterations assessment following ELN 2022 classification will be analyzed
- To identify potential predictive factors associated with duration of response and survival after VEN-AZA de-escalation, number of prior VEN-AZA cycles will be analyzed
研究者
GARCIAZ Sylvain
Scientific
Institut Paoli Calmettes
研究点 (5)
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