De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
Phase 2
Not yet recruiting
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Registration Number
- NCT06557421
- Lead Sponsor
- Institut Paoli-Calmettes
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- 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);
- ECOG <3;
- 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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VEN-AZA de-escalation Venetoclax VEN-AZA de-escalation VEN-AZA de-escalation Azacitidine VEN-AZA de-escalation
- Primary Outcome Measures
Name Time Method 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. 24 months
- Secondary Outcome Measures
Name Time Method Grade 3-4 adverse events occurence associated with VEN-AZA de-escalation. 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 Absolute duration of hematologic response, defined as the time from inclusion to relapse or death. 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