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Using Venetoclax and Azacitidine for treating acute myeloid leukemia in patients who can't have intensive chemotherapy

Results From a Nationwide Cohort Temporary Utilization Authorization (ATU) of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC),Treated in France With Venetoclax Azacitidine

Observational French Innovative Leukemia Organisation · NCT06263387

This study is testing if a combination of two medications, Venetoclax and Azacitidine, can help adults with newly diagnosed acute myeloid leukemia who can't have intensive chemotherapy.

Quick facts

Study typeObservational
Enrollment230 (estimated)
Ages18 Years and up
SexAll
SponsorFrench Innovative Leukemia Organisation Academic / other
Drugs / interventionschemotherapy
Locations42 sites (Amiens and 41 other locations)
Trial IDNCT06263387 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the use of Venetoclax and Azacitidine (VEN/AZA) in adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The treatment is provided under a temporary utilization authorization (ATU) program in France, allowing real-world data collection on its effectiveness and safety. The study aims to gather insights from the experiences of over 230 patients treated with VEN/AZA during the ATU period to inform healthcare professionals and decision-makers about the treatment's benefit-risk profile.

Who should consider this trial

Good fit: Ideal candidates are adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy.

Not a fit: Patients who have previously been treated for AML or those who oppose data collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a new effective option for patients with AML who cannot tolerate intensive chemotherapy.

How similar studies have performed: Other studies have shown promising results with Venetoclax and Azacitidine in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult patients
* treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy
* Treatment in the named-patients program (ATU)

Exclusion Criteria:

* Treatment with VEN-AZA for previously treated AML

  * Prior treatment for preexisting hematological malignancies other that AML, including AZA is not an exclusion criteria
  * HYDROXYCARBAMIDE given for AML is not an exclusion criteria
  * AZA started before VEN for AML is not an exclusion criteria
* Opposition to data collection

Where this trial is running

Amiens and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AML, Adult
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.