A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis
NCT ID: NCT05371964
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2022-05-04
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Imetelstat sodium + Ruxolitinib
Participants who have received ruxolitinib orally (PO) as part of standard of care (SOC) for at least 12 weeks prior to Screening will be enrolled. After enrollment, participants will initiate imetelstat sodium therapy. Dose levels of imetelstat sodium may include 4.7, 6, 7.5, 9.4 mg/kg, until a RP2D is established.
Imetelstat sodium
Imetelstat sodium will be administered as intravenous (IV) every 28 days.
Ruxolitinib
Ruxolitinib will be administered, orally (PO), twice daily (BID) in cohort B as the standard of care per local prescribing guidelines.
Part 2: Imetelstat sodium + Ruxolitinib
Cohort A: Janus Kinase (JAK) inhibitor naive participants will receive initial treatment with ruxolitinib on study for at least 12 weeks, including 4 consecutive weeks at a stable dose, prior to the addition of imetelstat sodium. Participants can begin imetelstat sodium treatment after sponsor review and approval and meet the following requirements: platelet value is ≥75 x 10\^9/L for two consecutive measurements, at least 1 week apart, and the participant does not meet criteria for dose delay.
Note that the study will no longer recruit participants into Cohort A.
Cohort B: Participants will receive treatment with ruxolitinib for 12 weeks with at least 4 consecutive weeks at a stable dose prior to enrollment and will start combination treatment with imetelstat on study.
Imetelstat sodium
Imetelstat sodium will be administered as intravenous (IV) every 28 days.
Ruxolitinib
Ruxolitinib will be administered, orally (PO), twice daily (BID) in cohort B as the standard of care per local prescribing guidelines.
Interventions
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Imetelstat sodium
Imetelstat sodium will be administered as intravenous (IV) every 28 days.
Ruxolitinib
Ruxolitinib will be administered, orally (PO), twice daily (BID) in cohort B as the standard of care per local prescribing guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dynamic International Prognostic Scoring System (DIPSS) intermediate-1, intermediate-2 or high-risk MF.
* Candidate for ruxolitinib treatment:
* Part 1 participants: On ruxolitinib treatment for at least 12 weeks with at least 4 consecutive weeks immediately prior to enrollment at a stable dose.
* Part 2 participants: Candidate for ruxolitinib treatment as assessed by the investigator and has not previously been treated with a JAK inhibitor (Cohort A) OR currently receiving ruxolitinib per standard of care for at least 12 weeks with at least 4 consecutive weeks at a stable dose prior to enrollment (Cohort B). Note that the study will no longer recruit participants into Cohort A.
* Active symptoms of MF on the MFSAF v4.0 demonstrated by:
* Part 1 participants only: At least 2 symptoms with a score ≥ 1
* Part 2 participants only: At least 2 symptoms with a score of ≥ 3, or a total score of at least 10.
* Ineligible for or unwilling to undergo hematopoietic stem cell transplant at time of study entry.
* Hematology laboratory test values within protocol defined limits.
* Biochemical laboratory test values within protocol defined limits.
* Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2.
* Participants should follow protocol defined contraceptives procedures.
* A woman of childbearing potential must have a negative serum or urine pregnancy test at screening.
Exclusion Criteria
* 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.
* Clinically significant cardiovascular disease.
* Known history of human immunodeficiency virus (HIV) or any uncontrolled active systemic infection requiring IV antibiotics.
* Active systemic hepatitis infection requiring treatment or any known acute or chronic liver disease unless related to MF. Carriers of hepatitis virus are permitted to enter the study.
18 Years
ALL
No
Sponsors
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Geron Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Mudge-Riley, DO
Role: STUDY_DIRECTOR
Geron Corporation
Locations
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City of Hope
Duarte, California, United States
City of Hope
Irvine, California, United States
University of Miami
Coral Gables, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Texas Oncology
Denison, Texas, United States
Texas Oncology
Tyler, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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MYF1001
Identifier Type: -
Identifier Source: org_study_id
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