Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Phase 1/2 Active not recruiting 52 enrolled M.D. Anderson Cancer Center Astex Pharmaceuticals, Inc. · collab Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of venetoclax in combination with cedazuridine and decitabine (ASTX727) in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia who have not received prior treatment (treatment-naive). Chemotherapy drugs, such as venetoclax, cedazuridine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Timeline

Start: 2021-01-19
Primary completion: 2028-07-20
Completion: 2028-07-20

Publications

Bataller A, Montalban-Bravo G, Bazinet A, Alvarado Y, Chien K, Venugopal S, Ishizawa J, Hammond D, Swaminathan M, Sasaki K, Issa GC, Short NJ, Masarova L, Daver NG, Kadia TM, Colla S, Qiao W, Huang X, Kanagal-Shamanna R, Hendrickson S, Ravandi F, Jabbour E, Kantarjian H, Garcia-Manero G. Oral decitabine plus cedazuridine and venetoclax in patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukaemia: a single-centre, phase 1/2 study. Lancet Haematol. 2024 Mar;11(3):e186-e195. doi: 10.1016/S2352-3026(23)00367-8. Epub 2024 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venetoclax	Small molecule	100 mg	Oral
Subject	Venetoclax	Small molecule	400 mg	Oral
Background	Cedazuridine	Small molecule	100 mg	Oral
Background	Decitabine	Small molecule	35 mg	Oral

Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Summary

Timeline

Publications

Drugs

Indications