Could some AML patients ditch chemo pills after a year?

NCT ID NCT06557421

Disease control Sponsor: Institut Paoli-Calmettes Source: ClinicalTrials.gov ↗

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

Summary

This study looks at whether people with acute myeloid leukemia (AML) who have responded well to a year of treatment with venetoclax and azacitidine can safely stop taking these drugs. Researchers will monitor 50 patients closely for signs of relapse and compare them to a similar group that continued treatment. The goal is to see if stopping therapy can maintain remission while reducing medication side effects.

What this could mean

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

Active substance: venetoclax and azacitidine
What this could lead to: If successful, this could show that some AML patients can safely stop these drugs after a year of treatment, reducing side effects and medication burden.
What could go wrong: This is a small, early-phase study with only 50 participants. Stopping treatment may lead to relapse, and results may not apply to all AML patients.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

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: 1. Female/Male ≥ 18 years of age; 2. Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias; 3. VEN-AZA given as first-line treatment; 4. Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses; 5. 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); 6. 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); 7. ECOG \<3; 8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 9. Affiliated to the French Social Security or beneficiary of such a health Insurance; 10. Signed informed consent. Non inclusion Criteria: 1. VEN-AZA given as salvage therapy; 2. Prior allogeneic stem cell transplant; 3. Discontinuation of treatment because of absence or loss of response; 4. Patient in emergency situation or unable to give consent; 5. Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could some AML patients ditch chemo pills after a year?

What the study statuses mean