Study Comparing Imetelstat to Best Available Therapy for Treating Intermediate-2 or High-risk Myelofibrosis Not Responding to JAK-Inhibitor Treatment
Sponsor: Geron Corporation
ClinicalTrials ID:NCT04576156
This clinical trial is testing whether the drug imetelstat can improve survival in patients with intermediate-2 or high-risk myelofibrosis who have not responded to JAK-inhibitor treatments, compared to the best available therapy.
Patient Parameters
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Program Overview
The study aims to see if imetelstat can help patients with intermediate-2 or high-risk myelofibrosis live longer compared to the best available therapy. It focuses on patients whose condition has not improved with JAK-inhibitor treatments. Participants will be randomly assigned to receive either imetelstat or the best available therapy. If their disease progresses on the best available therapy, they may switch to imetelstat with approval.
Description
This study involves three phases: a screening phase, a treatment phase, and a follow-up phase. During the screening phase, participants will stop all previous treatments, including JAK-inhibitors, for 14 days to ensure they are eligible for the study. In the treatment phase, participants will be randomly assigned to receive either imetelstat or the best available therapy. The follow-up phase begins after treatment ends and continues until the participant passes away, is lost to follow-up, withdraws consent, or the study ends. Participants who do not respond to the best available therapy may switch to imetelstat with the sponsor's approval.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with primary myelofibrosis or related conditions according to specific medical criteria.
- Classified as intermediate-2 or high-risk myelofibrosis.
- Not responding to JAK-inhibitor treatment and not eligible for stem cell transplantation.
- Have a measurable enlarged spleen.
- Experience active symptoms of myelofibrosis.
- Meet specific blood and biochemical test requirements.
- Have a performance status score of 0, 1, or 2, indicating good overall health.
- Agree to use contraception as defined by the study.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
Exclusion Criteria
- High levels of immature blood cells (blasts) in the blood or bone marrow.
- Allergies or intolerance to imetelstat or its ingredients.
- Previous treatment with imetelstat.
- Recent chemotherapy or myelofibrosis-directed therapy.
- Other cancers, unless treated and inactive for at least 3 years.
- Active infections requiring IV antibiotics or known HIV.
- Active hepatitis infection requiring treatment.
- Major surgery within 28 days before starting the study.
- Any serious illness or condition that could affect safety or study results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California-San Diego/Moores UCSD Cancer Center | 92093-1503 | La Jolla | California |
| UCLA David Geffen School of Medicine | 90096 | Los Angeles | California |
| Smilow Cancer Center at YNHH | 06511 | New Haven | Connecticut |
| Clermont Oncology | 34711 | Clermont | Florida |
| BRCR Medical Center Inc | 33326 | Plantation | Florida |
| University of South Florida | 33612 | Tampa | Florida |
| Fort Wayne Medical Oncology and Hematology | 46804 | Fort Wayne | Indiana |
| Goshen Center for Cancer Care | 46526 | Goshen | Indiana |
| Norton Cancer Institute | 40207 | Louisville | Kentucky |
| Our Lady of the Lake Cancer Institute | 70808 | Baton Rouge | Louisiana |
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