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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Institut Paoli-Calmettes
RECRUITING
Marseille
Contact Information
Primary
Jihane PAKRADOUNI, PharmD,PhD
drci.up@ipc.unicancer.fr
+33491223778
Backup
Laurie-Anne GOUTY, PhD
drci.up@ipc.unicancer.fr
33491223778
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 50
Treatments
Experimental: VEN-AZA de-escalation
VEN-AZA de-escalation
Related Therapeutic Areas
Sponsors
Leads: Institut Paoli-Calmettes

This content was sourced from clinicaltrials.gov