New study aims to close transplant gap for AML patients facing racial and economic barriers
NCT ID NCT06370000
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether taking oral azacitidine pills for up to six months can help prevent leukemia from returning in patients who are eligible for a stem cell transplant but cannot get one due to racial or socioeconomic disparities. The trial enrolls 12 adults with acute myeloid leukemia in remission. The main goal is to see if patients can complete at least four cycles of this maintenance therapy.
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
- What this could lead to
- If successful, this could offer a practical maintenance option to reduce relapse risk for AML patients who face barriers to transplant.
- What could go wrong
- This is a very small feasibility study with only 12 participants, so results may not apply broadly. The drug may not prevent relapse or could 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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Jan 2029
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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18 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: * Patients must have histologically or cytologically confirmed non-Acute Promyelocytic (APL) FLT3 negative AML and have completed induction and consolidation as defined by the treating physician and must be in complete response (CR), Complete response with partial hematologic recovery (CRh), or Complete response with incomplete count recovery (CRi) at time of study enrollment * For patients in CR1, AML disease phenotype must be one that is considered for allo HCT in CR1 (intermediate or high risk by European Leukemia Net (ELN), MRD+ CR, slow clearance of MRD) or any AML phenotype (aside from FLT3+ and APL) in CR2 and beyond * Medically eligible for allogeneic hematopoietic cell transplant (allo HCT) as defined by either: treating physician discretion, transplant physician discretion, or hematopoietic cell transplantation-specific Comorbidity index (HCT-CI) index of 5 or less * Age ≥ 18 years * Enrollment must occur within 4 months of completion of therapy * A patient or staff identified health disparity in 1 of the 5 Centers for Disease Control (CDC) defined social determinants of health (SDOH). This may include financial difficulties, lack of caregiver support, difficulties with medical literacy, rurality, appropriate access to health care, lack of an appropriate allogeneic hematopoietic cell transplant (allo HCT) donor, substance abuse * Patient must have adequate organ function defined as: Creatinine clearance (by Cockroft-Gault formula) greater than or equal to 29 mL/min, total bilirubin and aspartate aminotransferase/ alanine transaminase (AST/ALT) ≤ to institutional 2x upper limit of normal (except Gilbert's syndrome, which may enroll if \< 2x patient's baseline total bilirubin) * Eastern Cooperative Oncology Group (ECOG) 0,1,2,3 * Ability to take oral medications * No history of malabsorption syndrome which, in the investigator's opinion, may inhibit absorption of oral medications * Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Women who are breastfeeding are also excluded * Male patients must consent to effective contraception during study and at least 3 months after last dose * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria A patient who meets any of the following exclusion criteria is ineligible to participate in the study. * FMS-like tyrosine kinase 3 (FLT3 ITD) or tyrosine kinase domain (TKD) mutation * Uncontrolled central nervous system (CNS) involvement * History of hypersensitivity or allergic reaction to azacitidine or its components * Stem cell transplant within previous 3 months prior to initiation of study therapy * Uncontrolled intercurrent illness or infection * History of prior therapy with oral azacitidine * Female patients who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug * Male patients who intend to donate sperm during the course of this study or for 3 months after last dose * Other malignancy for which the patient is currently receiving therapy (except excisable skin cancer) * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk or limit the participant's adherence with study requirements
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?