A Phase 1 Study of Cirtuvivint Alone and With ASTX727 in People With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Full Title

A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination with ASTX727 in Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) (NCI 10674) (CIRB)

Purpose

Researchers are seeking the best dose of cirtuvivint to use alone and with ASTX727 for leukemia and myelodysplastic syndromes (MDS). The people in this study have acute myeloid leukemia (AML) or MDS that keeps growing after treatment.

Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine helps the bone marrow make normal blood cells and kills abnormal cells in the bone marrow. Cedazuridine prevents the breakdown of decitabine, making it more available in the body.

If you take part in this study, you will get cirtuvivint alone or with ASTX727. Both are taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have AML or MDS that keeps growing despite treatment.
  • Have completed prior therapies at least 2 weeks before taking the study treatment.
  • Be age 18 or older.
  • You may join this study even if you need help taking care of yourself. You may also join even if you are in a bed or chair for more than half the time you’re awake.

Contact

For more information or to see if you can join this study, please call Dr. Tamanna Haque’s office at 646-608-4166.

Protocol

25-267

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06484062