Clinical Trials
Our ongoing clinical trials and information about enrollment are listed below.
current studies
Clinical trial opportunities
Geron-sponsored trials
IMproveMF
IMproveMF is a two-part Phase 1 clinical trial evaluating imetelstat in combination with ruxolitinib in patients with Intermediate-1, Intermediate-2 or high-risk frontline MF. In Part 1 of the study, the objective is to identify a safe dose of the combination treatment. In Part 2, the objective is to confirm the dose of the combination treatment of imetelstat and ruxolitinib, and to evaluate efficacy.
IMproveMF is no longer screening or enrolling.
Myelofibrosis (MF)IMpact MF
IMpactMF, our pivotal Phase 3 clinical trial in JAK inhibitor relapsed/refractory MF, is an open label, 2:1 randomized, controlled clinical trial of imetelstat to evaluate a potential improvement in overall survival compared to best available therapy. The trial is expected to enroll approximately 320 patients with intermediate-2 or high-risk MF who are relapsed or refractory to treatment with a Janus associated kinase (JAK) inhibitor.
Investigator-sponsored trials
IMAGINE
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 acute myeloid leukemia (R/R AML). The objective is to evaluate the safety of imetelstat combined with azacitidine (Part A), then identify the optimal biological dose of imetelstat when used with azacitidine and venetoclax (Part B) in this patient population. The primary endpoint is to measure dose-limiting toxicities (DLTs) for imetelstat at two dose levels with azacitidine (Part A), and with azacitidine plus venetoclax during the first treatment cycle (Part B).
IMAGINE is open for screening and enrollment
Acute Myeloid Leukemia (AML)IMpress
IMpress is a Phase 2 clinical trial evaluating imetelstat as a single agent in patients with acute myeloid leukemia (AML) or high-risk MDS, who are relapsed/refractory/intolerant to hypomethylating agents, or HMAs. The objective of this trial is to evaluate the efficacy of single agent imetelstat in this patient population. The primary endpoint of this trial is overall response rate.
Enrollment for the IMpress clinical trial is now complete.
what to expect
Considering a clinical trial?
Participating in a clinical trial is an important personal decision. Understanding the process can help you feel more informed and confident as you explore your options with your healthcare team.
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Learn about available studies
Review available clinical trials and discuss with your healthcare team whether participation may be appropriate for your specific diagnosis and treatment history.
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Talk with your healthcare provider
Your doctor can help you understand whether a clinical trial may be an option and discuss the potential risks and benefits of participating.
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Eligibility screening
Every study has specific eligibility criteria designed to help answer important scientific questions while protecting participant safety.
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Participation
If you’re eligible and choose to enroll, you’ll receive detailed information about the study, including what to expect, required visits, assessments and potential risks and benefits, before providing informed consent.
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Ongoing care and follow-up
Throughout the study, participant safety remains the highest priority. Study teams closely monitor participants and provide ongoing support throughout the trial.
Every participant deserves gratitude
Clinical trials are only possible because patients, caregivers, healthcare professionals, and research teams choose to partner in the pursuit of better treatments.
For us, the connection between people and the therapies we are working to develop is what gives our research purpose. We recognize that participating in a clinical trial is a deeply personal decision. Whether or not someone chooses to enroll, we’re grateful to every individual who helps advance scientific understanding and contributes to the future of blood cancer care.
Access to investigational medicines
Clinical trials are the primary way for patients to access investigational medicines while the medicine’s safety and efficacy are being evaluated. We recognize that patients and healthcare providers may seek access to investigational medicines outside of a clinical trial in certain circumstances. For more information about Geron’s approach to expanded access, including current availability and how requests are considered. Please review our Expanded Access Policy.
The safety and efficacy of investigational medicines and uses described on this page have not been established. There is no guarantee that an investigational medicine or use will receive approval from any health authority or become commercially available in any country.
