Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia

Summary

This phase II trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or elderly patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive chemotherapy. Venetoclax may help block the formation of growths that may become cancer. ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Giving venetoclax and ASTX727 may help to control the disease.

Timeline

Start

2021-02-22

Primary completion

2026-10-31

Completion

2026-10-31

Publications

• Bazinet A, Garcia-Manero G, Short N, Alvarado Y, Bataller A, Abuasab T, Islam R, Montalbano K, Issa G, Maiti A, Yilmaz M, Jain N, Masarova L, Kornblau S, Jabbour E, Montalban-Bravo G, Rausch CR, Pierce S, DiNardo CD, Kadia T, Daver N, Konopleva M, Huang X, Kantarjian H, Ravandi F. Oral decitabine and cedazuridine plus venetoclax for older or unfit patients with acute myeloid leukaemia: a phase 2 study. Lancet Haematol. 2024 Apr;11(4):e276-e286. doi: 10.1016/S2352-3026(24)00033-4. Epub 2024 Mar 4.

Drugs

Indications