Stem cell transplant or drug combo: which better prevents leukemia return in seniors?
NCT ID NCT06903702
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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