OncoMatch/Clinical Trials/NCT07320235
Imetelstat Combinations in Relapsed AML
Is NCT07320235 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Imetelstat and Azacitidine for relapsed acute myeloid leukemia.
Treatment: Imetelstat · Azacitidine · Venetoclax — 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 of up to 36 participants will be accrued over 54 months at Mount Sinai Hospital. Estimated duration of trial is 114 months including recruitment, screening, treatment, and follow-up.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Lab requirements
Kidney function
Creatinine clearance (CrCl) ≥ 30 mL/min (measured or estimated by Cockcroft-Gault formula)
Liver function
Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) unless considered due to leukemic organ involvement or Gilbert's syndrome; AST and ALT ≤ 2.5 x ULN
Must have adequate organ function as demonstrated by the following: Serum total bilirubin ≤ 2.0 x ULN unless considered due to leukemic organ involvement or Gilbert's syndrome; AST and ALT ≤ 2.5 x ULN; CrCl ≥ 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Icahn School of Medicine at Mount Sinai · New York, New York
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