Actively Recruiting
A Phase 2 Study of Azacitidine and Venetoclax to Treat Acute Myeloid Leukemia Patients With Measurable Residual Disease Before an Allogeneic Stem Cell Transplant
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-24
30
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether a combination of azacitidine and venetoclax can effectively reduce or eliminate measurable residual disease (MRD) in adults with acute myeloid leukemia (AML) who have already received standard chemotherapy and plan to undergo an allogeneic hematopoietic stem cell transplant (HSCT). This transplant involves receiving healthy stem cells from a donor to replace the patient's immune system and help prevent the disease from returning. Participants receive treatment cycles lasting 28 days. Azacitidine is given at a dose of 75 mg/m2 daily for the first 7 days, usually through intravenous (IV) infusion or under the skin. Venetoclax is taken orally at 400 mg every day for all 28 days. This treatment is being evaluated before patients proceed to their planned stem cell transplant. During the study, participants will visit regularly for monitoring and assessments. Researchers will measure the rate of MRD conversion and the degree of MRD decrease over one year. Evaluations include blood tests, bone marrow biopsies, and other clinical assessments to track disease status and treatment effects. The study is sponsored by Memorial Sloan Kettering Cancer Center and aims to follow participants through these key outcome measures.
CONDITIONS
Brief Title
A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient 18 years of age or older at the time of signing informed consent
- Willing and able to follow study visits and protocol requirements
- Confirmed diagnosis of de-novo AML (non-APL) according to WHO 2022 guidelines
- Received 1 to 3 cycles of intensive chemotherapy for remission induction
- Currently in morphologic remission with less than 5% blasts in bone marrow
- In complete remission (CR), or CR with partial count recovery (CRi/CRh)
- Positive measurable residual disease (MRD) at or above specified levels by flow cytometry or molecular tests
- Eligible for intensive chemotherapy and planned allogeneic transplant after study
- ECOG performance status of 0 to 3
- Adequate organ function including liver enzymes, bilirubin, and creatinine clearance
- No active uncontrolled infection, heart failure, or severe psychiatric/neurological disease
- Negative pregnancy test for females of childbearing potential before treatment
- Use of effective contraception during study and specified period after last dose for females and males
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL) or relapsed/refractory AML
- Blast crisis of chronic myeloid leukemia
- Bone marrow blasts 5% or more
- Previous treatment with venetoclax-containing regimen
- Any condition increasing risk for study participation as judged by investigator
- Active uncontrolled systemic fungal, bacterial, or viral infection
- Recent significant thrombotic event requiring full anticoagulation or dual antiplatelet therapy
- Presence of mechanical heart valve
- Recent significant hemorrhagic episode
- Significant active cardiac disease within 6 months before treatment
- Known swallowing or gastrointestinal absorption disorders affecting oral drugs
- Pregnant or lactating females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive cycles of Azacitidine and Venetoclax to treat acute myeloid leukemia.
1 visit per cycle (in-person)
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
M
Meira Yisraeli Salman, MD
E
Eytan Stein, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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