Actively Recruiting
Phase 1B/2A Study of Weekly Decitabine and Venetoclax as Maintenance Therapy in High-Risk Myeloid Malignancy Patients After Allograft Stem Cell Transplant
Led by Benjamin Tomlinson · Updated on 2026-04-27
20
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new maintenance therapy for adults with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) who have undergone allogeneic stem cell transplant. The study aims to see if low doses of gentler chemotherapy, given after transplant, can prevent cancer relapse, improve survival, and reduce side effects. This treatment involves the drugs decitabine and venetoclax, and addresses the high relapse rates that remain a challenge after transplant. Participants will receive weekly low-dose decitabine injections followed by an oral venetoclax pill 6 to 8 hours later. This treatment will start no later than 40 days post-transplant and continue for up to one year, or until relapse or unacceptable side effects occur. Alongside this, participants will receive standard follow-up care after transplant. Bone marrow tests will be done at the beginning, midway, and end of the study to monitor disease status. During the study, participants will attend regular visits for treatment and monitoring. Researchers will assess safety by tracking dose-limiting toxicities and feasibility by measuring how many participants complete planned treatment over one year. They will also look at relapse-free survival rates. The study includes laboratory tests, clinical assessments, and close observation to understand how well the therapy controls leftover cancer cells and how tolerable it is for patients.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Diagnosis of acute myeloid leukemia, myelodysplastic syndromes (MDS), or MDS/AML with high or very high risk for post-transplant relapse
- Less than 5% myeloblasts in pre-transplant bone marrow with no circulating blasts
- Planned for or have received allogeneic stem cell transplant (alloSCT) with any conditioning or graft source
- Total bilirubin less than 2.0 mg/dL (or direct bilirubin less than 2 times upper limit for Gilbert's syndrome)
- Creatinine clearance greater than 30 ml/min
- ECOG performance status 0-1
- Ability and willingness to sign informed consent and complete study procedures
- Enrollment no later than 40 days post-transplant
- Successful engraftment with ANC ≥ 500/µL and platelet count ≥ 50,000/µL sustained for at least 3 days by day 50 post-transplant
- No active infection
- No graft-versus-host disease grade II or higher (skin grade 1 allowed)
- Less than 5% myeloblasts in bone marrow aspirate before starting maintenance therapy
You will not qualify if you...
- Prior disease progression on hypomethylating agent/venetoclax therapy or single-agent venetoclax
- Other planned post-transplant maintenance therapy such as FLT3-ITD targeting agents
- Currently pregnant or breastfeeding; females of childbearing potential must have negative pregnancy test
- Uncontrolled medical conditions limiting life expectancy or study compliance, including active infection, uncontrolled cancer, severe heart failure, unstable angina, unstable arrhythmia, decompensated liver cirrhosis
- Psychiatric or social conditions limiting study compliance
- Unwillingness to use dual contraception during study participation if of childbearing potential or sexually active male
- Known active HIV infection unless well controlled with stable treatment
- Known allergy or hypersensitivity to decitabine or venetoclax components
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year or until unacceptable toxicity
Participants receive weekly low-dose maintenance therapy with decitabine followed by venetoclax as post-transplant maintenance to reduce relapse risk.
Weekly visits for up to 1 year
Duration - Up to 1 year after treatment
Participants are monitored for safety, treatment response, and relapse after completing maintenance therapy.
Visits as per institutional post-transplant care standards
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
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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