NCT06557421

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
30mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Nov 2028

First Submitted

Initial submission to the registry

August 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

August 9, 2024

Last Update Submit

March 11, 2026

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (1)

VEN-AZA de-escalation

EXPERIMENTAL

VEN-AZA de-escalation

Drug: VenetoclaxDrug: Azacitidine

Interventions

VenetoclaxDRUG

complete discontinuation of Venetoclax

VEN-AZA de-escalation
AzacitidineDRUG

complete discontinuation of Azacitidine

VEN-AZA de-escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13273, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclaxAzacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Sylvain GARCIAZ, MD PhD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihane PAKRADOUNI, PharmD,PhD

CONTACT

+33491223778drci.up@ipc.unicancer.fr

Laurie-Anne GOUTY, PhD

CONTACT

33491223778drci.up@ipc.unicancer.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 16, 2024

Study Start

February 4, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)