Actively Recruiting
Imetelstat Combinations in Relapsed AML
Led by Douglas Tremblay · Updated on 2026-04-22
36
Participants Needed
1
Research Sites
493 weeks
Total Duration
On this page
Sponsors
D
Douglas Tremblay
Lead Sponsor
G
Geron Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Imetelstat Combinations in Relapsed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older at the time of signing informed consent.
- Participants must voluntarily sign an informed consent form.
- Participants must have WHO-confirmed non-APL AML that is relapsed or refractory after at least one prior therapy, with no standard beneficial therapy available.
- Participants with isolated extramedullary disease, including leukemia cutis, are eligible; those with active CNS disease are excluded.
- Participants must have a life expectancy of at least 12 weeks.
- Participants must have an ECOG performance status of 3 or less.
- Women of childbearing potential must have a negative pregnancy test at screening and before treatment, and agree to use effective birth control during and for 6 months after treatment.
- Male participants must agree to use effective contraception during and for 6 months after treatment.
- Participants must have adequate organ function including bilirubin, liver enzymes, and kidney function within specified limits.
- Participants must be able to adhere to study visit schedules and protocol requirements.
- Participants must understand and be willing to sign informed consent.
You will not qualify if you...
- Participants currently in or recently treated (within 2 weeks or 5 half-lives) with another investigational agent or device.
- Known active central nervous system leukemia.
- White blood cell count greater than 25 x 10^9/L, unless controlled with permitted medications.
- Active graft versus host disease requiring immunosuppressive treatment beyond specified exceptions.
- Recent or active cancer treatments within 2 years, except for certain localized or stable cancers.
- Recent heart attack or unstable angina within 6 months, or moderate to severe heart disease.
- Active serious infections, including untreated hepatitis or uncontrolled HIV.
- Serious unstable medical or psychiatric conditions that pose risk or interfere with consent or study data.
- Organ transplant recipients other than bone marrow transplant.
- Women who are pregnant or breastfeeding.
- Participants with gastrointestinal conditions or prior procedures that might interfere with venetoclax absorption (Part B only).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
G
Gabriela Bello
CONTACT
R
Rashmi Unawane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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