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

NCT ID: NCT06557421

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-12
• Study Completion Date: 2028-11-01

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

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VEN-AZA de-escalation

VEN-AZA de-escalation

Group Type: EXPERIMENTAL

Venetoclax

Intervention Type: DRUG

complete discontinuation of Venetoclax

Azacitidine

Intervention Type: DRUG

complete discontinuation of Azacitidine

Interventions

Venetoclax

complete discontinuation of Venetoclax

Intervention Type: DRUG

Azacitidine

complete discontinuation of Azacitidine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female/Male ≥ 18 years of age;

2. Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;

3. VEN-AZA given as first-line treatment;

4. Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses;

5. 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);

6. 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);

7. ECOG <3;

8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;

9. Affiliated to the French Social Security or beneficiary of such a health Insurance;

10. Signed informed consent.

1. VEN-AZA given as salvage therapy;

2. Prior allogeneic stem cell transplant;

3. Discontinuation of treatment because of absence or loss of response;

4. Patient in emergency situation or unable to give consent;

5. Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvain GARCIAZ, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Institut Paoli-Calmettes

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jihane PAKRADOUNI, PharmD,PhD

Role: CONTACT

drci.up@ipc.unicancer.fr

+33491223778

Laurie-Anne GOUTY, PhD

Role: CONTACT

drci.up@ipc.unicancer.fr

33491223778

Facility Contacts

Jihane PAKRADOUNI, PharmD, PhD

Role: primary

drci.up@ipc.unicancer.fr

33491223778

Laurie-Anne GOUTY, PhD

Role: backup

drci.up@ipc.unicancer.fr

33491223778

Other Identifiers

STOP VEN-IPC 2024-001

Identifier Type: -

Identifier Source: org_study_id