Actively Recruiting
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
Led by Institut Paoli-Calmettes · Updated on 2026-03-13
50
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with previously untreated Acute Myeloid Leukemia according to 2022 International Consensus Classification
- Receiving Venetoclax and Azacitidine as first-line treatment
- Completed approximately 12 months of Venetoclax and Azacitidine therapy (+/- 28 days)
- In first composite complete remission (complete remission or incomplete/partial hematologic recovery)
- No detectable minimal residual disease as determined locally
- Eastern Cooperative Oncology Group (ECOG) performance status less than 3
- No psychological, familial, sociological, or geographical issues affecting study compliance
- Affiliated with French Social Security or equivalent health insurance
- Provided signed informed consent
You will not qualify if you...
- Venetoclax and Azacitidine given as salvage therapy
- Previous allogeneic stem cell transplant
- Treatment stopped due to loss or absence of response
- Patient in emergency or unable to consent
- Severe medical or mental conditions preventing follow-up after treatment stop
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institut Paoli-Calmettes
Marseille, France, 13273
Actively Recruiting
Research Team
J
Jihane PAKRADOUNI, PharmD,PhD
CONTACT
L
Laurie-Anne GOUTY, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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