Actively Recruiting
Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
Led by Montefiore Medical Center · Updated on 2026-01-05
91
Participants Needed
3
Research Sites
257 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
T
The V Foundation for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Myeloid malignancies which include AML (acute myeloid leukemia) and MDS (myelodysplatic syndrome) are cancers of the bone marrow which lead to bone marrow failure. The bone marrow is the place or factory in the body where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability of the bone marrow to make these cells is decreased. The decreased bone marrow function is the result from abnormalities that develop in the malignant cells which prevent the normal maturation process by which bone marrow cells develop into red blood cells, white blood cells and platelets. The malignant cells in the bone marrow are not good at maturing to make the components of the blood that you need, they occupy space in the bone marrow and prevent the function of remaining normal bone marrow cells. DNA is a chemical substance within cells that stores information needed for cell growth and cell behavior. One approach to treating the malignant cells is to give chemotherapy which damages DNA within these cells and causes their death. Unfortunately, such therapy has side-effects, since even normal cells can be affected by the treatment. Decitabine is FDA approved for treatment of MDS and AML. Venetoclax is approved for AML in combination with Azacitidine for patients with AML or are over age 75 or unfit for chemotherapy. In this study, Decitabine and venetoclax will be administered using a low dose weekly schedule in an attempt to improve efficacy by decreasing the side effects often seen when these drugs are given at standard dosing.
CONDITIONS
Official Title
Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or myelodysplastic/myeloproliferative neoplasms (MDS/MPN) confirmed by hematopathology
- Indication for therapy with potential sensitivity to hypomethylating agents (HMA)
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or higher
- Adequate organ function: AST and ALT less than 4 times the upper limit of normal, bilirubin less than or equal to 2 times the upper limit of normal (with exceptions for certain conditions), creatinine clearance 30 mL/min or higher or on dialysis
- Ability to understand and willingness to sign informed consent and complete study procedures
You will not qualify if you...
- Acute promyelocytic leukemia (APL)
- Core binding factor AML patients eligible for chemotherapy
- Prior treatment with azacitidine, decitabine, or venetoclax
- Use of other disease-directed therapies (except hydroxyurea) within 14 days before study entry
- Currently pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test within 72 hours before treatment
- Uncontrolled illnesses limiting life expectancy or study participation, including active infections not controlled by treatment, uncontrolled malignancies, severe heart failure (NYHA class III/IV), unstable angina, new or unstable arrhythmias, decompensated liver cirrhosis, or psychiatric/social issues affecting compliance
- Unwillingness to use dual contraceptive measures during the study for women of childbearing potential and males
- Uncontrolled active HIV infection; patients with controlled HIV on stable therapy are eligible
- Known allergy or hypersensitivity to decitabine or venetoclax components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of California Davis Health (UC Davis Health)
Sacramento, California, United States, 95817
Actively Recruiting
2
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
3
White Plains Hospital
White Plains, New York, United States, 10601
Actively Recruiting
Research Team
M
Mendel Goldfinger, 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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