Actively Recruiting
A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-24
30
Participants Needed
7
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out if azacitidine and venetoclax are an effective treatment approach to get rid of or lower measurable residual disease (MRD) in people with acute myeloid leukemia (AML) who have received standard chemotherapy and are planning to have an allogeneic hematopoietic stem cell transplant (HSCT). Allogeneic HSCT, sometimes called a bone marrow transplant, involves receiving healthy blood-forming cells (stem cells) from a donor in order to replace the patient's immune system and lower the chances of the disease returning (relapse).
CONDITIONS
Official 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 the informed consent form
- Willing and able to follow the study visit schedule and protocol requirements
- Confirmed diagnosis of de-novo AML (non-APL) according to World Health Organization guidelines
- Received 1-3 cycles of intensive chemotherapy for remission induction
- In morphologic remission with less than 5% blasts in bone marrow biopsy
- In complete remission (CR) or CR with partial count recovery (CRi/CRh)
- Positive measurable residual disease (MRD) at or above 0.1% by flow cytometry or at or above 0.01% by RT-qPCR for molecular cases
- Eligible for intensive chemotherapy and allogeneic transplant with intention to proceed after trial
- ECOG performance status of 0 to 3
- Adequate organ function including liver enzymes, bilirubin, and kidney function
- No active uncontrolled infection, heart failure, or severe psychiatric or neurological disease
- Females of childbearing potential must have negative pregnancy tests before treatment
- Females of reproductive potential must use effective contraception during study and for 6 months after last azacitidine dose; males with female partners must use contraception during treatment and for 3 months after
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 a venetoclax-containing regimen
- Any condition increasing risk making patient inappropriate for study
- Active uncontrolled systemic fungal, bacterial, or viral infection
- Recent serious blood clots requiring full anticoagulation or dual antiplatelet therapy
- Mechanical heart valve
- Recent significant bleeding episode
- Significant active cardiac disease within 6 months before study
- Known swallowing or gastrointestinal absorption problems limiting oral drug intake
- Pregnant or breastfeeding females
AI-Screening
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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
CONTACT
E
Eytan Stein, MD
CONTACT
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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