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Recruiting NCT06557421

De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients

Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venetoclax, Azacitidine.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

  • Drug Venetoclax
    complete discontinuation of Venetoclax
  • Drug Azacitidine
    complete discontinuation of Azacitidine

Primary outcome measures

  • 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. [Time frame: 24 months]
Secondary outcome measures (12)
  • Absolute duration of hematologic response, defined as the time from inclusion to relapse or death. [Time frame: 24 months]
  • Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death. [Time frame: 24 months]
  • Cumulative incidence of relapse, defined as the probability of relapse over time. [Time frame: 24 months]
  • Overall survival, defined as the time from inclusion (VEN-AZA de-escalation) to death. [Time frame: 24 months]
  • Second complete remission occurence. [Time frame: 24 months]
  • Time to second remission, defined as the time between date of treatment re initiation and complete remission. [Time frame: 24 months]
  • Hospitalization rate associated with VEN-AZA de-escalation. [Time frame: 24 months]
  • Transfusion occurrence associated with VEN-AZA de-escalation. [Time frame: 24 months]
  • Grade 3-4 adverse events occurence associated with VEN-AZA de-escalation. [Time frame: 24 months]
  • Correlation between age and duration of response and survival after VEN-AZA de-escalation. [Time frame: 24 months]
  • Correlation between FAB classification and duration of response and survival after VEN-AZA de-escalation. [Time frame: 24 months]
  • Correlation between cytogenetic and molecular alterations and duration of response and survival after VEN-AZA de-escalation. [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Institut Paoli-Calmettes — Marseille

Identifiers

NCT: NCT06557421 · STOP VEN-IPC 2024-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗