Imetelstat Combinations for AML
(IMAGINE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for people with acute myeloid leukemia (AML) that hasn't responded to other treatments. The researchers aim to determine if imetelstat, used with azacitidine and sometimes venetoclax, is safe and effective for this type of leukemia. Individuals whose AML has returned or not improved after at least one other treatment, and who lack standard treatment options, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on certain treatments like immunosuppressants for GVHD, you may need to stop them at least 28 days before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of imetelstat and azacitidine was tested for safety and effectiveness. In a previous study, some patients experienced serious side effects, with infections being a concern. However, these issues mostly related to disease progression or other complications.
For the combination of imetelstat, azacitidine, and venetoclax, studies have found that this mix can extend the lives of some patients with AML. However, a few patients experienced serious side effects, such as pneumonia.
Overall, these treatments have shown potential but also carry risks, especially concerning infections. Prospective participants should consider these factors before deciding to join a trial.12345Why are researchers excited about this trial's treatments?
Imetelstat is unique because it targets telomerase, an enzyme that cancer cells use to maintain their immortality, which is different from most current treatments for acute myeloid leukemia (AML) that focus on killing rapidly dividing cells. Researchers are excited about imetelstat because it offers a novel approach by potentially stopping cancer cells from continuously replicating. The combination with azacitidine and possibly venetoclax aims to enhance this effect, offering a promising new strategy that could improve outcomes for patients with AML.
What evidence suggests that this trial's treatments could be effective for AML?
Research has shown that imetelstat may help treat leukemia by targeting and killing the stem cells responsible for the disease. Lab studies demonstrated that higher doses of imetelstat killed more of these harmful cells. In this trial, one arm will explore the combination of imetelstat with azacitidine to assess its potential benefits for treating AML (acute myeloid leukemia). Another arm will evaluate imetelstat in combination with azacitidine and venetoclax. Azacitidine combined with venetoclax is already known to be an effective treatment for AML, especially in older patients. Using these treatments together might enhance their effectiveness against the disease.12678
Who Is on the Research Team?
John Mascarenhas, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Douglas Tremblay, 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
Citations
NCT07320235 | 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 ...
Imetelstat Induces Leukemia Stem Cell Death in Pediatric ...
Imetelstat treatment significantly increased apoptosis/death of the LSC population in a dose-dependent manner in six pediatric AML PDX lines ex vivo, while it ...
3.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/3222/532549/A-Phase-II-Study-Evaluating-the-Efficacy-andA Phase II Study Evaluating the Efficacy and Safety of ...
Overall, 10 of the 30 SAEs resulted in death (n=5 due to disease progression/ transformation to AML, n=4 due to infectious complications and n=1 ...
A Phase II Study Evaluating the Efficacy and Safety ...
All patients achieving CR, CRi, PR or HI after 4 months of imetelstat were considered as responders and allowed to continue treatment until loss of response/ ...
High-Cost Therapy Profile: June 2024
Treatment with imetelstat in the clinical trial for LR-MDS resulted in statistically significant improvements in RBC-transfusion independence ( ...
Real-world treatment patterns and outcomes with oral ...
Rates of real-world relapse-free survival and overall survival at 12 months from oral-AZA initiation were 66.9% and 74.5%, respectively. During ...
A Phase II Study Evaluating the Efficacy and Safety of ...
Overall, 10 of the 30 SAEs resulted in death (n=5 due to disease progression/ transformation to AML, n=4 due to infectious complications and n=1 due to ileus) ...
Press Release Details
The results suggest that imetelstat demonstrates RBC-transfusion-related clinical activity and increases in hemoglobin in these patients ...
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