Imetelstat Combinations for AML
(IMAGINE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Douglas Tremblay, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
John Mascarenhas, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
This trial is for adults with relapsed or refractory Acute Myelogenous Leukemia (AML) who have tried at least one prior therapy and have no other standard treatment options. They must be in a stable enough condition to participate, not pregnant, willing to use effective birth control, and have acceptable liver function tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-In
Safety run-in phase to monitor dose-limiting toxicities of imetelstat in combination with azacitidine
Phase 1b Combination Therapy
Phase 1b trial to determine the optimal biological dose of imetelstat in combination with azacitidine and venetoclax
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Imetelstat
- Venetoclax
Trial Overview
The IMAGINE trial is testing the combination of Imetelstat with Azacitidine, with or without Venetoclax, in AML patients. It includes an initial safety phase followed by a dose-finding study to determine the best biological dose of Imetelstat when combined with these drugs.
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
* 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Douglas Tremblay
Lead Sponsor
Geron Corporation
Industry Sponsor
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