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Could a pill keep AML at bay? new study tests maintenance therapy after chemo

NCT ID NCT06349239

Disease control Sponsor: Centre Hospitalier Universitaire de Nice 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether taking oral azacitidine (Onureg) as maintenance therapy can help older adults with acute myeloid leukemia (AML) stay in remission longer after treatment with CPX-351 chemotherapy. The study included 100 patients aged 65 and older who had achieved remission. Researchers tracked overall survival and side effects to see if this approach is safe and effective for those who cannot undergo a stem cell transplant.

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 (Onureg)
What this could lead to
If successful, this could provide a way to keep AML in remission longer for older patients who cannot have a stem cell transplant.
What could go wrong
This is a small, completed study with no control group, so results may not be definitive. Oral azacitidine can cause side effects like nausea or low blood counts.

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

100 people

The number who actually took part.

Started

Oct 2024

Finished

Jun 2026

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.

Who is studied

Patient with de novo AML, therapy-related AML or AML with myelodysplasia related changes in first remission (CR1, CRi1, CRh1 according to IWG) after CPX-351 induction with or without CPX-351 consolidation.

Ages

64 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: * Male or female subjects \> 64 years of age at the time of C1J1 CPX-351 * de novo AML including t-AML or AML-MRC according to WHO 2016 * Should have undergone induction therapy with CPX-351 with or without CPX-351 consolidation * Patients in first line of treatment * Should have achieved first CR/CRi/CRh status according to IWG criteria * ECOG performance status of 0,1,2,3 Exclusion Criteria: * Prior bone marrow or stem cell transplantation * patients having achieved CR/CRi following an added therapy * Patients alive at the start of the study who did not receive study information or who objected to the collection of data

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with multilineage dysplasia therapy-related myeloid neoplasm

As listed by the trial registrant

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

Acute myeloid leukemia

Contacts and locations

Locations

  • CHU de Nice

    Nice, France

More trials for these conditions

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