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NCT05600894 · ClinicalTrials.gov record · last posted 2026-08-19

Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm

StatusActive, Not Recruiting
PhasePhase 2
Started2023-06-27
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from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-20
critical
Primary completion pushed: 2026-08-31 → 2027-08-31
2026-08-20
minor
Completion pushed: 2026-08-31 → 2027-08-31
Trial Details
NCT Number NCT05600894
Lead Sponsor National Cancer Institute (NCI)
Conditions Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm
Enrollment 132 participants
Start Date 2023-06-27
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-19