CC-486 and Venetoclax for Acute Myeloid Leukemia

This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.

Trial Details

NCT ID
NCT05287568
Phase
PHASE1
Sponsor
University of Colorado, Denver
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Venetoclax
  • CC-486
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • Subject must have confirmation of non-APL AML by WHO criteria46 and have undergone at least one line of therapy (dose escalation and dose expansion…
  • For the newly diagnosed cohort, subjects must be unlikely to tolerate standard intensive chemotherapy due to age, performance status, or comorbidit…
  • a. age ≥75 years old OR b. age \< 75 years old with at least one of the following: i. ECOG performance status of 3 ii. Cardiac history of CHF or do…
  • Patients must have ECOG of 0 to 3 (if \< 75 years old) or 0 to 2 (if ≥75 years old)

For full eligibility, visit ClinicalTrials.gov.

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