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Decitabine and Venetoclax for Myelodysplastic Syndromes and Acute Myeloid Leukemia

This study is testing a new way to give two drugs, Decitabine and Venetoclax, to people with Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). These are cancers of the bone marrow, which makes blood cells. The goal is to see if giving these drugs in lower, weekly doses can help more people stay on treatment without needing breaks or dose changes, compared to current standard dosing. The study plans to enroll up to 91 participants. To join, you must be at least 18 years old and have one of these diagnoses that doctors believe might respond to a type of treatment called hypomethylating agents (HMA). The main way this study will measure success is by looking at how many participants can continue treatment without interruptions or delays for up to 12 weeks. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of up to 91 participants. It will have an initial safety phase followed by an expansion phase.
What's involved
Participants will receive Venetoclax by mouth on days 1, 8, 15, and 22, and Decitabine as a shot under the skin on days 2, 9, 16, and 23 of each 28-day cycle. Treatment is expected to continue for at least 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants are anticipated to remain on treatment for at least 12 weeks, with the primary endpoint measured at up to 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05184842

Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML

Recruiting
PHASE2Ages 18+InterventionalTreatment
Montefiore Medical Center
~91 participants
Updated 2026-01-05 on ClinicalTrials.gov
What's tested:VenetoclaxDecitabine

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Who Are Able to Continue on Treatment Without Dose Interruptions or Delays
Measured over Up to 12 weeks

Conditions

Myelodysplastic Syndromes
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia

Explore related trials

Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic Syndrome

Where it's being run

3 sites across 2 states
New York2
California1

Study leadership

  • Mendel Goldfinger, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Mendel Goldfinger, MD
[email protected]
718-920-4826
Email the study team

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Eligibility criteria

Inclusion

Patient must have a diagnosis of myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN) with a histopathologic diagnosis confirmed by hematopathology review
Indication for therapy with potential sensitivity to hypomethylating agents (HMA) therapy, defined as prior published evidence of response to HMA
Patients must be 18 years of age or older
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3
Patients must have adequate end organ function defined as.
Aspartate aminotransferase (AST) and Alanine transaminase (ALT) \< 4× the upper limit of normal (ULN)
Bilirubin ≤ 2× the ULN (upper limit of normal). If elevated bilirubin is due to impaired conjugation (e.g., Gilbert's disease or concomitant medication) or disease related hemolysis, then direct bilirubin ≤ 1.5× the ULN
As decitabine and venetoclax have little renal metabolism, and have proven safety even in dialysis patients, renal function with a creatinine clearance ≥30 mL/min or on dialysis is allowed
Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures.

Exclusion

Acute promyelocytic leukemia (APL)
Core binding factor AML who are candidates for chemotherapy
Prior Treatment with azacitidine, decitabine or venetoclax
No other disease directed therapy, save for hydroxyurea, including experimental or investigational drug therapy for 14 days prior to study entry
Currently pregnant or breast-feeding. Females of childbearing potential (FOCBP) 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 intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:
Women of Child-Bearing Potential (WOCBP) 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, she 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
Patients with uncontrolled active HIV infection, as this will further increase the risk for opportunistic infections. However, patients with HIV with undetectable viral load by polymerase chain reaction (PCR), without opportunistic infection, and on a stable regimen of antiretroviral therapy would be eligible
Known allergy or hypersensitivity to any component of decitabine or venetoclax formulations

What this trial measures

  • Percentage of Participants Who Are Able to Continue on Treatment Without Dose Interruptions or DelaysUp to 12 weeks

    The percentage of participants who are able to continue on treatment without dose interruptions or delays was defined as not having to delay or interrupt treatment due to toxicity or intolerability for more than two weeks during the 12-week induction period.