New combo aims to wipe out lingering leukemia before transplant
NCT ID NCT06773208
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether two drugs, azacitidine and venetoclax, can eliminate or reduce measurable residual disease (MRD) in adults with acute myeloid leukemia (AML) who have completed standard chemotherapy and are scheduled for a donor stem cell transplant. The goal is to lower the chance of the cancer returning after transplant. About 30 participants will receive the drugs for up to 28 days per cycle, and researchers will check bone marrow samples for MRD clearance.
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
- What this could lead to
- If successful, this approach could help more AML patients achieve a cancer-free state before transplant, potentially lowering relapse risk.
- What could go wrong
- This is a small, early-phase study (30 people) and may not work for everyone. Side effects from the drugs or transplant complications remain possible.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 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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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: * 1\. Adult patient ≥18 years of age at the time of signing the informed consent form (ICF). Legal Authorized Representatives (LAR) are permitted. 2\. Patient is willing and able to adhere to the study visit schedule and other protocol requirements. 3\. Patient has a confirmed diagnosis of de-novo AML (non-APL) as per World Health Organization (2022) guidelines. All (non-APL) subtypes of AML are permitted, irrespective of ELN risk category or mutational status. 4\. Patient has received 1-3 cycles of intensive chemotherapy for remission induction. 5\. Patient is in a morphologic remission, defined as less than 5% percent blasts seen by aspirate differential (or immunohistochemistry if no aspirate available) from bone marrow biopsy. 6\. Patient and is either in CR, or CR with partial count recovery, either CRi/CRh\\\^1. 1CR= BM with \<5% blasts, absence of circulating blasts; absence of extramedullary disease, absolute neutrophil count (ANC) ≥ 1000 cells/µL and platelet (PLT) count ≥ 100,000/µL. CRh = CR with ANC 500-1000 cells/µL and PLT 50,000-100,000 /µL. CRi = CR without meeting CRh criteria (residual neutropenia or thrombocytopenia). 7\. Patient has positive measurable residual disease (MRD) at or above a level of 0.1%, by flow cytometry (MFC) or in molecular cases (NPM1 mutated or one of the CBF translocations) RT-qPCR at or above 0.01%, as described above (see section 3.6). If RT-qPCR is not available, MFC will be allowed for determining eligibility for molecular patients (at or above 0.1%). 8\. Patient is eligible for intensive chemotherapy and immediate allogeneic transplant, with intention to proceed to transplant after trial intervention. 9\. Patient has an ECOG performance status of ≤3 10. Patient has adequate organ function defined as: 1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN 2. Serum total bilirubin \< 1.5 x ULN (or direct bilirubin normal in subjects with total bilirubin \> 1.5 ULN). Except in cases of Gilbert's disease. 3. Creatinine clearance greater than 30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation. 11\. Absence of active uncontrolled infection, heart failure or severe psychiatric or neurological disease. 12\. Females of childbearing potential may participate provided they have a negative serum pregnancy test at screening and a negative serum OR urine pregnancy test within two weeks of starting on treatment. 13\. Females of reproductive potential should use effective contraception during the study, and for 6 months after last dose of azacitidine. Males with female partners of reproductive potential should use effective contraception during treatment and for 3 months after. Exclusion Criteria: 1\. Patients with acute promyelocytic leukemia (APL) or relapsed/refractory AML 2. Blast crisis of chronic myeloid leukemia 3. Patient with 5% blasts or more by bone marrow aspirate differential (or IHC if no aspirate available) 4. Patient has received previous therapy with a venetoclax containing regimen. 5. Patient has 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. 6\. Patient has active uncontrolled systemic fungal, bacterial, or viral infection. 7\. Patient had recent, significant venous or arterial thrombotic event that would necessitate full anticoagulation or dual anti-platelet therapy, including PE within 30 days prior to start of treatment or insertion of drug eluting stent within 6 months prior to start of treatment. Chronic indications for anticoagulation such as atrial fibrillation, can be included if CHADS2 score below 4. 8\. Patient has mechanical heart valve. 9. Patient had recent significant hemorrhagic episode, at the discretion of investigator. 10\. Patient has significant active cardiac disease within 6 months prior to start of study treatment. 11\. Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. 12\. Female subject who is pregnant or lactating.
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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
7 sites. 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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Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a liposomal drug combo improve AML treatment for older adults?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Can an Anti-Inflammation drug make AML chemotherapy work better?
- Can a new drug trio overcome venetoclax resistance in leukemia?
- Can engineered cells beat relapsed blood cancers?
- Can a new pill outsmart resistant leukemia?