Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 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 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 cla

Trial Details

NCT ID
NCT06484062
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Cirtuvivint
  • Decitabine and Cedazuridine
  • Echocardiography Test
  • Multigated Acquisition Scan
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Chicago, Illinois, United States|41.85003,-87.65005
  • New Lenox, Illinois, United States|41.51198,-87.96561
  • Orland Park, Illinois, United States|41.63031,-87.85394

Key Eligibility Criteria

  • In Cohorts I and II, patients must have R/R AML or MDS (venetoclax naïve or venetoclax exposed)
  • Relapsed AML is defined as the appearance of 5% or greater myeloblasts in the bone marrow or peripheral blood after achieving a complete remission …
  • Refractory AML is defined as failure to achieve a CR, CRh, or CRi after one of the following regimens: (i) ≥ 2 cycles of intensive induction chemot…
  • Patients with MDS/AML (blasts 10-19%) who progress to AML (blasts ≥ 20%) after treatment will be considered relapsed or refractory MDS/AML, and not…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →