Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine
Dates
study started
completion around
Principal Investigator
by Deepa Jeyakumar (uci)Brian A. Jonas (ucdavis)

Description

Summary

This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts. Blasts are immature blood cells. 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. 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. 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. The combination of ASTX727 and venetoclax may be more effective in reducing the cancer signs and symptoms in patients with CMML, or MDS/MPN with excess blasts.

Official Title

Venetoclax In Combination With ASTX727, an All-ORal TherapY for Chronic Myelomonocytic Leukemia and Other MDS/MPN With Excess Blasts (VICTORY-MDS/MPN): a Randomized, Phase 2 Trial

Details

Keywords

Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm, Leukemia, Neoplasms, Preleukemia, Leukemia, Myelomonocytic, Acute, Leukemia, Myelomonocytic, Chronic, Leukemia, Myelomonocytic, Juvenile, Myelodysplastic Syndromes, Myeloproliferative Disorders, Myelodysplastic-Myeloproliferative Diseases, Anemia, Refractory, with Excess of Blasts, Syndrome, Venetoclax, Decitabine, Decitabine and cedazuridine drug combination, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Decitabine and Cedazuridine, ASTX727, venetoclax, ASTX727

Eligibility

Locations

Lead Scientists at University of California Health

  • Deepa Jeyakumar (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 37 research publications
  • Brian A. Jonas (ucdavis)
    Professor, MED: Int Med HMCTBMT, School of Medicine. Authored (or co-authored) 98 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT05600894
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 132 study participants
Last Updated