Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Sanjay Mohan
Study ID
NCT05799079
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Given by mouth
  • Decitabine — DRUG
    Given by mouth
  • Cedazuridine — DRUG
    Given by mouth
  • Bone Marrow Aspiration and Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

This phase II trial tests how well decitabine and cedazuridine (DEC-C) works in combination with venetoclax in treating acute myeloid leukemia (AML) in patients whose AML has come back after a period of improvement (relapse) after a donor stem cell transplant. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving DEC-C in combination with venetoclax may kill more cancer cells in patients with relapsed AML.

Key Dates

Start date
Apr 13, 2023
Status verified
Sep 2025
Primary completion
Sep 20, 2024
Completion
Sep 20, 2024

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Venetoclax, DEC-C)
    Patients receive venetoclax PO daily for 28 days in a 28-day cycle. Patients receive DEC-C PO daily on days 1-5 of a 28-day cycle. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.

Primary Outcome Measure

Number of Participants That Achieved a Complete Response to Therapy [ Time Frame: 9 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-

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Vanderbilt University/Ingram Cancer Center· Nashville, TN

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