Actively Recruiting
A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-08-05
100
Participants Needed
7
Research Sites
103 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 65 years of age or older at the time of signing the informed consent form
- Confirmed diagnosis of acute myeloid leukemia according to ELN 2017 criteria
- Treatment with azacitidine and venetoclax for AML diagnosis
- First study treatment cycle starts 28-42 days after second cycle of standard azacitidine/venetoclax
- Additional azacitidine/venetoclax cycle allowed if transplant is delayed due to donor issues
- Adequate organ function for transplant eligibility: cardiac (LVEF >40%), renal (CrCl ≥50 ml/min), pulmonary (DLCO >50%), hepatic (liver tests <5x ULN, bilirubin <2x ULN unless benign)
- Karnofsky Performance Status (KPS) of 70 or higher
- Suitable donor available for allogeneic stem cell transplant
- Achieved morphologic remission with less than 5% blasts and MRD negative status by flow cytometry
- Willing and able to follow study visit schedules and protocol requirements
You will not qualify if you...
- Not eligible for transplant due to lack of suitable donor or comorbidities/performance status
- History of prior allogeneic hematopoietic stem cell transplant
- Prior leukemia treatments other than azacitidine and venetoclax
- Central nervous system involvement before enrollment
- Previous exposure to venetoclax or hypomethylating agents for myeloid malignancy treatment
- Planned treatment other than azacitidine and venetoclax
- Planned treatment combining hypomethylating agents and venetoclax with another agent
- Any condition that increases risk or makes participation inappropriate in investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Consent and Follow-up)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
R
Roni Tamari, MD
CONTACT
E
Eytan Stein, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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