A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older … (NCT06903702) | Clinical Trial Compass
WithdrawnPhase 2
A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia
Stopped: Lack of funding
0Started 2026-08-04
Plain-language summary
The researchers are doing this study to find out if an allogeneic hematopoietic stem cell transplant (HSCT) or maintenance therapy with azacitidine and venetoclax is more effective at keeping AML from coming back (relapsing).
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \>1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was withdrawn before enrolling anyone — do you know why it was pulled, and does that tell us anything important about the azacitidine plus venetoclax combination versus transplant as a strategy for my situation?
2Since this was going to be a Phase 2 study comparing drug therapy to stem cell transplant in people 65 and older, what does the existing evidence say about how these two approaches compare for someone my age with AML?
3The trial was focused on relapse-free survival at one year — based on what's already known, how do azacitidine and venetoclax stack up against transplant on that measure for patients like me?
4Are there other open trials or standard-of-care options that are currently asking the same question this study was trying to answer, so we can still explore all my options?
5Given that this trial specifically targeted patients 65 and older, does my age or overall fitness level meaningfully affect whether a stem cell transplant would even be on the table for me compared to a drug-only approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.