Imetelstat Combinations in Relapsed AML

IMAGINE is a two-part trial to evaluate the safety and preliminary efficacy of imetelstat in combination with azacitidine with or without venetoclax in patients with relapsed or refractory AML. The trial will consist of a safety run-in phase (Part A) employing a 3+3 design to monitor dose-limiting toxicities of imetelstat when administered in combination with a fixed dose of azacitidine. Part B will consist of a phase 1b trial employing a BOIN12 design to determine the optimal biological dose of imetelstat, starting at a lower dose level, in combination with azacitidine and venetoclax. Total o

Trial Details

NCT ID
NCT07320235
Phase
PHASE1
Sponsor
Douglas Tremblay
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Imetelstat
  • Azacitidine
  • Venetoclax
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Participants must be ≥18 years of age at time of signing the Informed Consent Form (ICF).
  • Participants must voluntarily sign an ICF.
  • Participants must have WHO-confirmed non-APL AML who have not responded to or relapsed after at least one prior therapy and for whom no standard th…
  • o Participants with isolated extramedullary disease (EMD), including leukemia cutis, are included but not those with active known CNS disease.

For full eligibility, visit ClinicalTrials.gov.

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