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Trial of Decitabine and Venetoclax with Transplant for Myeloid Malignancies

This study is testing the safety of adding two drugs, Decitabine and Venetoclax, to a reduced intensity transplant (using Fludarabine and Melphalan) for people with certain blood cancers like Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). Researchers want to see if these drugs can be safely given together with the transplant. The study will enroll about 20 participants aged 18 to 75 who have a suitable stem cell donor. The main goal is to measure any serious side effects within the first 28 days after transplant. The current status of this study is unclear.

Study design
This study is an interventional trial designed to evaluate safety and preliminary activity. It will follow a 3+3 design, commonly used in early-phase studies, with dose adjustments based on side effects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring dose-limiting toxicities is up to 28 days after transplant.

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NCT07044544

Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies

Recruiting
PHASE1Ages 18–75InterventionalTreatment
University of Alabama at Birmingham
~20 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:G-CSFDecitabineVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measuring changes in dose limiting toxicities
Measured over Up to 28 days

Conditions

Myeloid Malignancy
Hematologic Malignancy
Acute Myeloid Leukemia
Myelodysplastic Syndromes

Explore related trials

Acute Myeloid LeukemiaMiller-Dieker SyndromeMyelodysplastic SyndromeMBD5 wt Allele

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Omer A Jamy, MD · PRINCIPAL_INVESTIGATOR · The University of Alabama at Birmingham

Who to contact

Omer Jamy, MD
[email protected]
(205) 934-4793
Email the study team

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Eligibility criteria

Inclusion

AML: A. Any AML with active disease (defined as ≥ 5% blasts in the marrow), with no available re-induction strategies, or further therapy is not felt to be effective by treating physician.
MDS:
MDS/MPN \>5% blasts and spleen \< 22 cm with no available pre-transplant strategies, or further therapy is not felt to be effective by treating physician. 12. Subject is willing and able to sign informed consent and abide by the protocol requirements.

What this trial measures

  • Measuring changes in dose limiting toxicitiesUp to 28 days

    Determine the safety of adding Decitabine and Venetoclax to patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances with Fludarabine and Melphalan.