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Decitabine and Venetoclax as Maintenance Therapy After Stem Cell Transplant

This study is testing if low doses of two drugs, decitabine and venetoclax, given after an allogeneic stem cell transplant (a type of bone marrow transplant) can help prevent acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) from coming back. These conditions are myeloid malignancies, which are cancers of the blood and bone marrow. The goal is to see if this treatment can control any remaining cancer with fewer side effects than standard chemotherapy. You would receive decitabine once a week and then take a venetoclax pill later the same day, in addition to your usual post-transplant care. The study will look at how safe the treatment is and if it's practical to give to patients. You may be eligible if you are 18 or older and have AML or MDS with a high risk of relapse after transplant. The study is currently recruiting about 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants, but the phase and status are not specified.
What's involved
Participants will receive decitabine once per week and take venetoclax about 6 to 8 hours later, along with normal transplant follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and feasibility for 1 year after treatment.

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NCT06129734

Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant

Recruiting
PHASE1Ages 18+InterventionalTreatment
Benjamin Tomlinson
~20 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:VenetoclaxDecitabine

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as measured by dose limiting toxicities
Measured over 1 year after treatment
+1 more outcome measured

Conditions

Myeloid Malignancy
Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

2 sites across 1 states
Ohio2

Study leadership

  • Benjamin Tomlinson, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  • James Ignatz-Hoover, MD, PhD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  • Claudio Brunstein, MD, PhD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Who to contact

Benjamin Tomlinson, MD
[email protected]
(216) 844-0139
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of Acute myeloid leukemia, MDS, MDS/AML with high-risk for post-transplant relapse identified by:
Very high or high risk by CIBMTR Disease Risk Index (DRI) and/or adverse risk by ICC 2022 criteria and/or MDS/AML by ICC 2022 criteria.
Very high or high risk by CIBMTR DRI and/or by IPSS-M \> 0.510-12 and/or MDS/AML by ICC 2022 criteria.
Bone marrow myeloblasts \<5% at pre-transplant bone marrow aspirate and biopsy with no circulating blasts.
Participants must be planned for or have received alloSCT. Any conditioning regimen intensity or graft source (MRD/MUD/Haplo/UCB) is permitted.
Participants must be 18 years of age or older.
Total bilirubin \< 2.0 mg/dL (with the exception of participants with known Gilbert's syndrome, who should have direct bilirubin \< 2 × ULN).
Creatinine clearance (CrCl) \> 30 ml/min.
ECOG 0-1 performance status.
Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures.
Successful engraftment defined by absolute neutrophil count (ANC) of ≥500/ul and platelet count of ≥50,000/uL sustained for at least three consecutive days.
These criteria for engraftment should be met on or before Day +50.
No active infection
No GVHD ≥ overall grade II (Grade 1 GVHD of the skin acceptable).

Exclusion

Prior disease progression on HMA/VEN therapy, single agent venetoclax.
Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician
Currently pregnant or breast-feeding. Females of childbearing (FOCBP) potential must have negative serum pregnancy test within 72 hours from treatment start. (NOTE: FOCBP is any biologic female, regardless of sexual or gender orientation, having undergone tubal ligation, or remaining celibate by choice, who has not undergone a documented hysterectomy or bilateral oophorectomy or has had a menses any time in the preceding 12 months (therefore not naturally post-menopausal for \> 12 months)
Uncontrolled comorbid illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:
Active infection
Uncontrolled concurrent malignancy
Congestive heart failure of NYHA class III/IV. Participants with compensated heart failure are permitted.
Unstable angina pectoris
New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted
Decompensated liver cirrhosis (Child-Pugh score ≥12 or a MELD score ≥21
Psychiatric illness/social situations that would limit compliance with study requirements.
Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the participants or impair the assessment of study results.
FOCBP and males that are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, they should inform the treating physician immediately
Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last dose of decitabine/venetoclax.
Participants with known active HIV infection, as this will further increase the risk for opportunistic infections. However, participants with chronic HIV with undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of antiretroviral therapy would be eligible.
Known allergy or hypersensitivity to any component of decitabine/venetoclax

What this trial measures

  • Safety as measured by dose limiting toxicities1 year after treatment

    The primary objective of this study will be to assess the safety of low dose decitabine/venetoclax in the post transplant setting. Safety will be defined in accordance with FDA guidance on development for new therapeutics in AML with the particular criteria to be considered as DLTs. The stopping criteria are described for the incidence of dose limiting toxicities that are at least possibly related to the study treatment. Using Bayesian toxicity monitoring with maximum DLT probability as 0.15, prior distribution (0.5, 0.5), maximum participants 20, minimum number of participants before stopping 9, cohort size 5, and posterior probability 0.8, the study will be paused for review if (2, 3, 4, 5) or more participants experiencing such Grade 4 events in (69, 11, 16, 20) participants, respectively.

  • Feasibility as measured by the rate of participants receiving planned treatment1 year after treatment

    The primary objective of this study will be to assess the feasibility of low dose decitabine/venetoclax in the post transplant setting. Feasibility will be defined as ≥ 80% of participants receiving ≥80% of planned decitabine/venetoclax doses, excluding participants removed from the study in the event of relapse.