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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Venetoclax
  • Azacitidine

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators