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A Study of Imetelstat with Ruxolitinib for Myelofibrosis

This study is looking at the safety and effects of combining two drugs, imetelstat sodium and ruxolitinib, for people with myelofibrosis (a bone marrow disorder). Researchers want to find the best dose of imetelstat sodium to use with ruxolitinib. They will also check for any side effects and see how well the combination works to improve symptoms. You may be able to join if you are 18 or older and have been diagnosed with primary myelofibrosis, or myelofibrosis that developed after essential thrombocythemia or polycythemia vera. The study will measure side effects and how many participants have symptom improvement at 24 weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 36 participants. It aims to find the right dose of imetelstat sodium to combine with ruxolitinib, and then evaluate the safety and activity of that combination.
What's involved
Imetelstat sodium will be given through a vein every 28 days. Ruxolitinib will be taken by mouth twice daily. The study will monitor you for adverse events from the first dose until 30 days after your last dose, for up to approximately 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events until 30 days after the last dose of study treatment, for up to approximately 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05371964

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Geron Corporation
~30 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Imetelstat sodiumRuxolitinib

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Incidence, Type, and Severity of Adverse Events, Including Dose-limiting Toxicity (DLT) During the DLT Observation Period and/or Study Treatment
Measured over 28 days after first dose
+2 more outcomes measured

Conditions

Myelofibrosis

Explore related trials

Myelofibrosis

Where it's being run

6 sites across 4 states
California2
Florida2
New York1
Washington1

Study leadership

  • Michelle Mudge-Riley, DO · STUDY_DIRECTOR · Geron Corporation

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of primary myelofibrosis (PMF) according to the revised World Health Organization (WHO) criteria or post-essential thrombocythemia-MF or post-polycythemia vera according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) 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

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.
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.

What this trial measures

  • Part 1: Incidence, Type, and Severity of Adverse Events, Including Dose-limiting Toxicity (DLT) During the DLT Observation Period and/or Study Treatment28 days after first dose
  • Part 2: Number of Participants With Treatment-emergent Adverse Event (AE)First dose of study treatment until 30 days after the last dose of study treatment (up to approximately 5 years)

    Safety will be assessed based on incidence and severity (according to Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the first dose of study treatment until 30 days after completion of treatment.

  • Part 2: Symptom Response Rate at Week 24Week 24

    Symptom response rate is defined as percentage of participants with \>=50% reduction in the Total Symptom Score (TSS) measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 e-diary at 24 week compared to baseline.