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French study tracks Real-World use of oral azacitidine for AML in remission

NCT ID NCT06565975

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study collected real-world data from 112 adults in France with acute myeloid leukemia (AML) who were in remission and taking oral azacitidine as maintenance therapy. The goal was to describe patient characteristics, treatment patterns, and outcomes like relapse and survival. It did not test a new treatment but observed how this approved drug works in everyday practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral azacitidine

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

112 people

The number who actually took part.

Started

May 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients diagnosed with histologically confirmed de novo acute myeloid leukemia, therapy-related acute myeloid leukemia, or secondary acute myeloid leukemia who received maintenance therapy with oral azacitidine while in remission after front-line treatment or in second remission

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants who initiated oral azacitidine maintenance therapy during early access program (EAP) in France (January 29, 2021 to July 13, 2022) or during the 6 months post-EAP (from July 14, 2022, to January 2014, 2023) inside the marketing authorization label "adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT)." * Participants with histologically confirmed diagnosis of de novo AML, or therapy-related AML, or secondary AML * Participants who received frontline treatment after diagnosis of AML and achieved complete remission (CR), CR with incomplete blood count recovery (Cri), or CR with partial hematology recovery (CRh) after one or subsequent lines of therapy in case of relapse * Participant is at least 18 years of age at the time of initial diagnosis of AML * Participants alive or deceased at the time of data collection * Physician has access to the complete medical record for the patient, including any transferred records from other facilities (if applicable); patient's medical record must at least include the following: * Date of diagnosis of AML * Frontline therapy(ies) received, and treatment start dates * Date(s) of first documented evidence of response * Oral azacitidine start and (if applicable) stop date * Documentation (yes/no) of relapse on oral azacitidine, where applicable * Participants who do not object to the data collection Exclusion Criteria: * Participants who initiated maintenance with oral azacitidine after January 14, 2023 * Participant who initiated maintenance with oral azacitidine before January 14, 2023, outside of the marketing authorization label

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia (AML)

Contacts and locations

Locations

  • Kappa Sante

    Paris, 75002, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.