Actively Recruiting
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis
Led by Geron Corporation · Updated on 2026-01-06
36
Participants Needed
8
Research Sites
325 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary myelofibrosis (PMF) by WHO criteria or post-essential thrombocythemia-MF or post-polycythemia vera by IWG-MRT criteria
- DIPSS intermediate-1, intermediate-2, or high-risk myelofibrosis
- Candidate for ruxolitinib treatment
- Part 1 participants: On ruxolitinib at a stable dose for at least 12 weeks with 4 consecutive weeks before enrollment
- Part 2 participants: Either have not been treated with a JAK inhibitor (Cohort A) or have been on stable ruxolitinib for at least 12 weeks prior (Cohort B)
- Active myelofibrosis symptoms: Part 1 participants must have at least 2 symptoms with a score 61;1; Part 2 participants must have at least 2 symptoms with score 61;3 or a total score of at least 10
- Ineligible for or unwilling to undergo stem cell transplant at study entry
- Hematology and biochemical lab tests within protocol limits
- ECOG performance status 0, 1, or 2
- Follow protocol-defined contraceptive procedures
- Women of childbearing potential must have a negative pregnancy test at screening
You will not qualify if you...
- Peripheral blood or bone marrow blast count 61;10%
- Prior JAK inhibitor treatment (except dose-optimized participants before enrollment in Part 1 or Part 2 Cohort B)
- Known allergies or intolerance to imetelstat, ruxolitinib, or excipients
- Prior treatment with imetelstat
- Major surgery within 28 days before enrollment
- Use of investigational drugs, hydroxyurea, chemotherapy, immunomodulatory or immunosuppressive therapy, or high-dose corticosteroids within 14 days before enrollment (except dose-optimized ruxolitinib)
- Prior hematopoietic stem cell transplant
- Malignancy other than MF unless treated with curative intent and no active disease for at least 3 years or adequately treated skin or cervical cancer without evidence of disease
- Clinically significant cardiovascular disease
- Known HIV infection or uncontrolled active systemic infection requiring IV antibiotics
- Active systemic hepatitis requiring treatment or acute/chronic liver disease unless related to MF; hepatitis virus carriers allowed
AI-Screening
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Trial Site Locations
Total: 8 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope
Irvine, California, United States, 92618
Actively Recruiting
3
University of Miami
Coral Gables, Florida, United States, 33146
Actively Recruiting
4
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, United States, 33612
Actively Recruiting
5
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
6
Texas Oncology
Denison, Texas, United States, 75020
Withdrawn
7
Texas Oncology
Tyler, Texas, United States, 75702
Withdrawn
8
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Michelle Mudge-Riley, DO
CONTACT
J
Judy Ho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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