Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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: 1.
- - Clinical signs/symptoms of MF demonstrated by one of the following: 1.
- - 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.
- - Peripheral blood blast count of ≥10% or bone marrow blast count of ≥10% - Prior treatment with JAK inhibitor.
- - 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, immunomodulatory or immunosuppressive therapy, corticosteroids >30 mg/day prednisone or equivalent ≤14 days prior to enrollment.
- - Prior history of hematopoietic stem cell transplant.
- - Prior history of partial or complete splenectomy.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Tymara Berry, MD|
|Principal Investigator Affiliation||Geron Corporation|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Imetelstat + Ruxolitinib
Part 1: Participants who have received ruxolitinib orally (PO) as part of standard of care (SOC) for at least 12 weeks (maximum 24 weeks) prior to Screening will be enrolled. After enrollment, participants will initiate imetelstat therapy. Dose levels of imetelstat may include 4.7, 6, 7.5, 9.4mg, until a RP2D is established. Part 2: JAK inhibitor naïve participants will receive initial treatment with ruxolitinib for at least 12 weeks (maximum 24 weeks), including 4 weeks at a stable dose, followed by imetelstat treatment at the RP2D in combination with ruxolitinib.
Drug: - Imetelstat
Imetelstat sodium will be administered as intravenous (IV) every 28 days.
Drug: - Ruxolitinib
Ruxolitinib will be administered, orally (PO), twice daily (BID) as the standard of care per local prescribing guidelines.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.