Imetelstat Combinations in Relapsed AML

Part of paid clinical trials in New York, New York.

Sponsor
Douglas Tremblay
Study ID
NCT07320235
Phase
PHASE1
Status
Recruiting
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Conditions

  • Relapsed Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Imetelstat — DRUG
    Three 3 dose levels administered on Day 1 of each 28-day cycle for Safety Run-in Phase and optimal dose to be administered on Day 1 of each 28-day cycle
  • Azacitidine — DRUG
    75mg/m2 IV or subcutaneous (SQ) once daily for Days 1 (+/- 1 day) through 7 (+/- 1 day) of each 28-day cycle. Azacitidine can be administered locally as long as documentation of administration is provided to the study team.
  • Venetoclax — DRUG
    Venetoclax 400mg oral once daily for Days 1 (+/- 1 day) through 14 (+/- 1 day) of each 28-day cycle. Venetoclax reduced dosey should be substituted if concomitant posaconazole, or if other concomitant strong CYP3A4 inhibitor (e.g. voriconazole) or 200mg for moderate CYP3A4 inhibitor (e.g. isavuconazole). For Cycle 1, participants will receive a venetoclax ramp-up dose on day 1, day 2, and days 3-14 of venetoclax,. If the participant is being treated with concomitant posaconazole, or other concomitant strong CYP3A4 inhibitor, or with a concomitant moderate CYP3A4 inhibitor or a pg-p inhibitor, participants will receive a lower ramp-up dose on day 1, day 2, and days 3-14 of venetoclax.

Study Details

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.

Key Dates

Start date
Jan 2, 2026
Status verified
Apr 2026
Primary completion
Jun 17, 2030
Completion
Jun 15, 2035

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Part A Safety Run-In phase: Imetelstat in combination with Azacitidine
    Part A combination therapy: * Imetelstat will be administered on Day 1 of each 28-day cycle * Azacitidine once daily for Days 1 (+/- 1 day) through 7 (+/- 1 day) of each 28-day cycle.
  • Active Comparator: Part B Combination Therapy: Imetelstat in combination with Azacitidine with or without Venetoclax
    * Imetelstat will be administered on Day 1 of each 28-day cycle * Azacitidine once daily for Days 1 (+/- 1 day) through 7 (+/- 1 day) of each 28-day cycle. * Venetoclax once daily for Days 1 (+/- 1 day) through 14 (+/- 1 day) of each 28-day cycle.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 Day 1 up to Cycle 1 Day 28 (each cycle is 28 days), for 6 cycles ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Gabriela Bello
[email protected]
(212) 241-0463
Rashmi Unawane
[email protected]
212-824-2385
Douglas Tremblay (PRINCIPAL_INVESTIGATOR)

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By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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