Actively Recruiting
Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS
Led by Montefiore Medical Center · Updated on 2026-01-08
99
Participants Needed
1
Research Sites
340 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax at different doses and duration will inform the appropriate dose(s) and regimen(s) for Part 2. In Part 2, the dose expansion phase, a maximum of 28 additional patients will be randomized 1:1 to the MTD determined in Part 1 and the starting dose (assuming the MTD is not the starting dose), to further evaluate the safety and efficacy of the study drug combination.
CONDITIONS
Official Title
Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis of acute myeloid leukemia by WHO criteria or higher risk myelodysplastic syndrome with 10% or more blasts or proliferative CMML-2 at investigator discretion
- Aged 18 to 75 years
- ECOG performance status of 2 or less
- Adequate kidney function with creatinine clearance over 30 mL/min
- Adequate liver function with bilirubin less than 1.5 times the upper limit of normal (unless due to Gilbert's disease or leukemia) and AST/ALT less than 3 times the upper limit of normal (unless due to leukemia)
- Able to understand and provide informed consent
- Male participants must agree to avoid unprotected sex and sperm donation during treatment and for 90 days after last dose
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or t(15;17) chromosomal abnormality
- Active central nervous system involvement with leukemia
- Severe heart failure (NYHA Class III or IV) or left ventricular ejection fraction under 45%
- History of recent heart attack within 6 months, unstable angina, or severe uncontrolled heart rhythm problems
- Active uncontrolled infection with HIV or hepatitis B or C
- Conditions affecting swallowing or absorption of oral medications
- Any significant medical or psychiatric condition that may interfere with study participation
- White blood cell count above 25 x 10^9/L (with some allowed treatments to reduce this)
- Women who are nursing, pregnant, or not willing to use effective contraception
AI-Screening
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Trial Site Locations
Total: 1 location
1
Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
I
Ioannis Mantzaris, 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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