A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis (NCT05371964)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the study is to identify the recommended Part 2 dose (R2PD) of imetelstat sodium in combination with ruxolitinib in participants with myelofibrosis (MF) in Part 1, and to evaluate the safety and preliminary clinical activity of the R2PD of imetelstat sodium in combination with ruxolitinib in participants with MF in Part 2.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (15 items).
Location: City of Hope — Duarte, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Peripheral blood blast count of ≥10% or bone marrow blast count of ≥10%.
- Prior treatment with JAK inhibitor (except for participants being dosed optimized on ruxolitinib treatment prior to screening and enrollment in part 1 or Part 2 Cohort B).
- Known allergies, hypersensitivity, or intolerance to imetelstat or ruxolitinib or excipients.
- Prior treatment with imetelstat.
- Major surgery within 28 days prior to enrollment.
- Any investigational drug regardless of class or mechanism of action, hydroxyurea, chemotherapy, (except for ruxolitinib for participants being dose optimized prior to enrollment), immunomodulatory or immunosuppressive therapy, corticosteroids \>30 mg/day prednisone or equivalent ≤14 days prior to enrollment.
- Prior history of hematopoietic stem cell transplant.
- Diagnosis or treatment for malignancy other than MF, except:
- Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- City of Hope — Duarte, California
- City of Hope — Irvine, California
- University of Miami — Coral Gables, Florida
- H. Lee Moffitt Cancer Center and Research Institute, Inc. — Tampa, Florida
- Icahn School of Medicine at Mount Sinai — New York, New York
- Fred Hutchinson Cancer Center — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.