Actively Recruiting
Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
Led by Benjamin Tomlinson · Updated on 2026-04-27
20
Participants Needed
2
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main question it aims to answer is whether or not providing a new, gentler way of administering chemotherapy will help control leftover cancer with minimal side effects. This treatment involves decitabine and venetoclax. Participants will receive standard post-transplant care. Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later. Participants will meet their study team at the beginning, midway, and at the end of the trial to receive bone marrow testing. Participants will receive treatment until either one year of therapy, relapse, or recurrent dose limiting toxicity (DLT) despite dose reduction.
CONDITIONS
Official Title
Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia, myelodysplastic syndromes, or MDS/AML at high risk for relapse after transplant
- Bone marrow myeloblasts less than 5% before transplant with no circulating blasts
- Planned for or have received an allogeneic stem cell transplant of any graft source or conditioning intensity
- 18 years of age or older
- Total bilirubin less than 2.0 mg/dL (except for Gilbert's syndrome with specific limits)
- Creatinine clearance greater than 30 ml/min
- ECOG performance status of 0 or 1
- Able to understand and willing to sign informed consent and complete study procedures
- Enroll before or within 40 days after transplant
- Successful engraftment by day 50 (ANC ≥ 500/ul and platelets ≥ 50,000/uL for 3 days)
- No active infection or GVHD grade II or higher (grade 1 skin GVHD allowed)
- Less than 5% myeloblasts in bone marrow aspirate at treatment start
You will not qualify if you...
- Prior progression on hypomethylating agent and venetoclax therapy or venetoclax alone
- Planned use of other post-transplant maintenance therapies like FLT3-ITD inhibitors
- Pregnant or breastfeeding females; females of childbearing potential must have negative pregnancy test
- Uncontrolled illness limiting life expectancy or study participation, including active infections, uncontrolled malignancies, severe heart failure (NYHA III/IV), unstable angina or arrhythmias, decompensated liver cirrhosis, psychiatric or social issues
- Unwillingness to use dual contraception methods if of childbearing potential
- Sexually active males unwilling to use condoms during study and 4 weeks after last dose
- Known active HIV infection (except controlled chronic HIV on stable therapy)
- Known allergy or hypersensitivity to decitabine or venetoclax components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
2
University Hospitals Seidman Cancer, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
B
Benjamin Tomlinson, 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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