Stem cell transplant or drug combo: which better prevents leukemia return in seniors?

NCT ID NCT06903702

What the study statuses mean

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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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study tests two strategies to keep acute myeloid leukemia (AML) from coming back in people aged 65 and older who have achieved remission after initial treatment. One group receives a stem cell transplant, while the other continues on a maintenance drug combination of azacitidine and venetoclax. The goal is to see which approach leads to longer relapse-free survival.

What this could mean

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

Active substance
azacitidine and venetoclax (drugs); allogeneic stem cell transplant (procedure)
What this could lead to
If successful, this trial could identify the best approach to keep AML from returning in older patients, potentially improving long-term survival without the need for indefinite medication.
What could go wrong
This is a phase II trial with a relatively small number of participants, so results may not apply to all patients. Stem cell transplants carry serious risks, including infection and graft-versus-host disease, and the drug combination may cause side effects.

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.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

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

65 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: * Adult patients ≥65 years of age at the time of signing the informed consent form. * Confirmed diagnosis of acute myeloid leukemia according to the ELN 2017 criteria * Treatment with azacitidine and venetoclax for the diagnosis of AML o The first cycle of study treatment will start 28-42 days after the start of the second cycle of SOC AZA/VEN. In the event that patients can't be admitted for allo-HCT until after Day 42 due to donor related issues, an additional cycle of AZA/VEN will be allowed as a bridge to the transplant, and then initiation of conditioning will start no later than day 42 after the start of the third cycle. * Patients with adequate organ function to be considered as candidates for allo-HCT: * Cardiac: asymptomatic or if symptomatic, then LVEF at rest must be \>40% and must improve with exercise. * Renal: CrCl ≥50 ml/min (measured or calculated/estimated). * Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin) * Hepatic: \< 5x ULN liver function tests and \< 2x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia. * KPS of ≥ 70 * Patients with suitable donor for allo-HCT * Patients must achieve a morphologic remission \<5% blast with MRD negative status by flow cytometry (defined as one or less residual leukemic blasts per 1000 leukocytes (or 10\^3)) meeting one of the below: * Complete remission (CR) defined as: \<5% blasts with ANC\> 1000 AND Plt \>100K * CRh defined as \<5% blasts with ANC \> 500 AND Plt \>50K * CRi defined as \<5% blasts with ANC\< 1000 OR Plt \< 100K * Subject is willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: * Patients who are not considered to be transplant eligible (either due to lack of suitable donor or due to comorbidities/performance status). The reason the patient is not considered transplant eligible will be documented in the eCRF. * History of prior allo-HCT * Patients who underwent prior leukemia directed treatment (other than aza/ven) * Patients with CNS involvement at any time point prior to enrollment. * Patients with previous exposure to venetoclax or an HMA for the treatment of a myeloid malignancy * Patients who are planned for treatment other than AZA/VEN * Patients who are planned for treatment with HMA/VEN with another agent (e.g. a "triplet") * Presence of any other condition that may increase the risk associated with study participation, and in the opinion of the investigator, would make the patient inappropriate for entry into the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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