A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment
Launched by GERON CORPORATION · Oct 2, 2020
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called imetelstat for patients with myelofibrosis (MF), a type of blood cancer, who have not responded well to standard treatments known as JAK inhibitors. The goal is to see if imetelstat can help these patients live longer compared to the best available therapy currently offered. This study is specifically looking for adults aged 65 and older who have intermediate-2 or high-risk MF and have experienced a relapse or worsening of their condition after JAK inhibitor treatment.
To be eligible for the trial, participants should have a confirmed diagnosis of myelofibrosis and show specific signs of the disease, such as a large spleen and active symptoms that impact their daily life. They should not have received certain treatments or have other serious health conditions that could interfere with the study. Participants in the trial can expect to receive either imetelstat or the best available therapy, and they will be closely monitored for their overall health and response to treatment throughout the study. This trial is actively recruiting participants who meet the criteria and are looking for new treatment options.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of primary myelofibrosis according to the revised World Health Organization criteria or post-essential thrombocythemia-MF or post-polycythemia vera-MF according to the IWG-MRT criteria
- • Dynamic International Prognostic Scoring System intermediate-2 or high-risk MF
- * Relapsed/refractory to JAK-inhibitor treatment as defined in either inclusion (i), (ii) or (iii) and not eligible for allogeneic stem cell transplantation (ASCT) at screening:
- * (i) Treatment with JAK-inhibitor for \>= 6 months duration, including at least 2 months at an optimal dose as assessed by the investigator for that participant and at least one of the following:
- • 1. no decrease in spleen volume (\< 10% by MRI or CT) from the start of treatment with JAK-inhibitor
- • 2. no decrease in spleen size (\< 30% by palpation or length by imaging) from the start of treatment with JAK-inhibitor
- • 3. no decrease in symptoms (\< 20% by Myelofibrosis Symptom Assessment Form \[MFSAF\] or myeloproliferative neoplasm SAF) from the start of treatment with JAK-inhibitor
- • 4. a score of at least 15 on TSS assessed using the MFSAF v4.0 during screening.
- • (ii) Treatment with JAK-inhibitor treatment for\>= 3 months duration with maximal doses (e.g., 20-25 mg twice daily ruxolitinib) for that participant and no decrease in spleen volume/size or symptoms as defined in inclusion criterion (i \[a, b, or c\]).
- • (iii) Following maximum tolerated doses of JAK inhibitor therapy for ≥3 months duration, having documented relapsed disease defined as either
- • 1. Increase in spleen volume from time of best response by 25% measured by MRI or CT, or
- • 2. Increase in spleen size by palpation, CT, or ultrasound
- • (b.i) For splenomegaly of 5-10 cm at the start of JAK inhibitor treatment, at least 100% increase in palpable spleen size from time of best response;
- • (b.ii) For splenomegaly of \> 10 cm at the start of JAK inhibitor treatment, at least 50% increase in palpable spleen size from time of best response;
- • AND not a candidate for further JAK inhibitor at screening per investigator.
- • Measurable splenomegaly demonstrated by a palpable spleen measuring \>= 5 cm below the left costal margin or a spleen volume \>= 450 cm\^3 by MRI or CT
- • Active symptoms of MF on the MFSAF v4.0 demonstrated by a symptom score of at least 5 points (on a 0 to 10 scale)
- • Hematology laboratory test values within the protocol defined limits
- • Biochemical laboratory test values must be 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:
- • Peripheral blood blast count of \>= 10% or bone marrow blast count of \>=10%
- • Known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
- • Prior treatment with imetelstat
- • Any chemotherapy or MF directed therapy, including investigational drug regardless of class or mechanism of action, immunomodulatory or immunosuppressive therapy, corticosteroids greater than 30 mg/day prednisone or equivalent, and JAK-inhibitor treatment less than equal to 14 days prior to randomization
- * 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 randomization
- • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- • Adequately treated cervical carcinoma in situ without evidence of disease
- • Known history of human immunodeficiency virus or any uncontrolled active systemic infection requiring IV antibiotics
- • Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus are permitted to enter the study), or any known acute or chronic liver disease requiring treatment unless related to underlying hepatosplenomegaly due to MF
- • Major surgery within 28 days prior to randomization
- • Any life-threatening illness (e.g., coronavirus disease-2019), medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the imetelstat metabolism, or put the study outcomes at undue risk
About Geron Corporation
Geron Corporation is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, particularly through its proprietary telomerase inhibitor platform. With a commitment to advancing science and improving patient outcomes, Geron is dedicated to addressing unmet medical needs in oncology. The company actively conducts clinical trials to evaluate the safety and efficacy of its lead product candidates, leveraging cutting-edge research to bring transformative therapies to patients with hematologic malignancies and solid tumors. Through strategic partnerships and a robust pipeline, Geron aims to establish itself as a leader in cancer therapeutics.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Durham, North Carolina, United States
Sioux Falls, South Dakota, United States
Linz, , Austria
Houston, Texas, United States
Hobart, Tasmania, Australia
Herston, Queensland, Australia
Haifa, , Israel
New York, New York, United States
Canton, Ohio, United States
Salt Lake City, Utah, United States
San Diego, California, United States
Tacoma, Washington, United States
Zurich, , Switzerland
Tacoma, Washington, United States
Tampa, Florida, United States
London, , United Kingdom
Curitiba, , Brazil
St Leonards, New South Wales, Australia
Milano, , Italy
Louisville, Kentucky, United States
Tübingen, , Germany
Wels, , Austria
Seoul, , Korea, Republic Of
São Paulo, , Brazil
Taichung City, , Taiwan
Goshen, Indiana, United States
Seoul, , Korea, Republic Of
New Orleans, Louisiana, United States
Kuching, Sarawak, Malaysia
Taipei, , Taiwan
Bangalore, Karnataka, India
Durham, North Carolina, United States
Alicante, , Spain
Roma, , Italy
Richmond, Victoria, Australia
Leipzig, Sachsen, Germany
Córdoba, , Argentina
Incheon, , Korea, Republic Of
Kota Bharu, Kelantan, Malaysia
Long Beach, California, United States
Taipei, , Taiwan
Houston, Texas, United States
Maidstone, Kent, United Kingdom
Seoul, , Korea, Republic Of
Curitiba, Paraná, Brazil
Roseville, Michigan, United States
Gent, Oost Vlaanderen, Belgium
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Sioux Falls, South Dakota, United States
Floridablanca, , Colombia
Seoul, , Korea, Republic Of
York, Pennsylvania, United States
Omaha, Nebraska, United States
Ogden, Utah, United States
Pleven, , Bulgaria
Valencia, , Spain
New Delhi, Delhi, India
Porto, , Portugal
Georgetown, Pulau Pinang, Malaysia
Firenze, , Italy
Madrid, , Spain
Watertown, South Dakota, United States
Columbus, Ohio, United States
Fort Wayne, Indiana, United States
Fredericksburg, Virginia, United States
Edegem, Antwerpen, Belgium
Tübingen, Baden Württemberg, Germany
Ampang, Selangor, Malaysia
Busan, , Korea, Republic Of
Leipzig, Saxony, Germany
Antwerpen, , Belgium
Torino, , Italy
Pune, , India
Izmir, , Turkey
Hartford, Connecticut, United States
Ankara, , Turkey
Cáceres, , Spain
Katowice, , Poland
Rockville, Maryland, United States
Genova, Liguria, Italy
Istanbul, , Turkey
Antwerpen, , Belgium
Haifa, , Israel
Varese, , Italy
Seoul, , Korea, Republic Of
Valencia, , Spain
Istanbul, , Turkey
Torino, , Italy
Long Beach, California, United States
Saint Joseph, Missouri, United States
Omsk, , Russian Federation
Springfield, Missouri, United States
Bologna, , Italy
Salem, Oregon, United States
Meldola, , Italy
Busan, Busan Gwang'yeogsi [Pusan Kwangyokshi], Korea, Republic Of
Milano, Lombard, Italy
Genova, , Italy
Milano, , Italy
Bhubaneswar, Orissa, India
Rosario, Santa Fe, Argentina
Goiânia, , Brazil
Alessandria, , Italy
Zaragoza, , Spain
Wels, Oberösterreich, Austria
'Aiea, Hawaii, United States
Johor Bahru, Johor, Malaysia
Fayetteville, Arkansas, United States
La Jolla, California, United States
Los Angeles, California, United States
Plantation, Florida, United States
Houston, Texas, United States
Ciudad De Buenos Aires, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Wein, Burgenland, Austria
Linz, Oberösterreich, Austria
Haine Saint Paul, Hainaut, Belgium
Antwerpen, , Belgium
Antwerpen, , Belgium
Jette, , Belgium
Fortaleza, Ceará, Brazil
Goiânia, Goiás, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
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São Paulo, , Brazil
São Paulo, , Brazil
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Pereira, Risaralda, Colombia
Antioquia, , Colombia
Cali, , Colombia
Floridablanca Santander, , Colombia
Aarhus, , Denmark
Odense, , Denmark
Nimes Cedex 09, Gard, France
Tours, Indre Et Loire, France
Nantes, Loire Atlantique, France
Avignon Cedex, Provence Alpes Côte D'azur, France
Pierre Benite, Rhône Alpes, France
Le Mans, Sarthe, France
Bobigny, Seine Saint Denis, France
Brest Cedex, , France
Paris, , France
Paris, île De France, France
Georgia, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tübingen, Baden Württemberg, Germany
Dresden, Hamburg, Germany
Halle (Saale), Sachsen Anhalt, Germany
Kiel, Schleswig Holstein, Germany
Kempten, , Germany
Budapest, , Hungary
Budapest, , Hungary
Nyíregyháza, , Hungary
Székesfehérvár, , Hungary
New Delhi, Delhi, India
Surat, Gujarat, India
Bengaluru, Karnataka, India
Gurgaon, New Delhi, India
Kolkata, West Bengal, India
Hyderabad, , India
Pune, , India
Ashdod, Hadarom, Israel
Ashkelon, Hadarom, Israel
Rehovot, Hamerkaz, Israel
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Tel Aviv, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
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Orbassano, Torino, Italy
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Genova, , Italy
Milano, , Italy
Monza, , Italy
Napoli, , Italy
Ravenna, , Italy
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Rimini, , Italy
Roma, , Italy
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Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Busan, , Korea, Republic Of
Seongdong, , Korea, Republic Of
Kelantan, , Malaysia
Slupsk, Pomorskie, Poland
Piła, Wielkopolskie, Poland
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Katowice, śląskie, Poland
Braga, , Portugal
Coimbra, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Moscow, Moskovskaya Oblast', Russian Federation
Novosibirsk, Novosibirskaya Oblast', Russian Federation
Saratov, Saratovskaya Oblast', Russian Federation
Tula, Tul'skaya Oblast', Russian Federation
Omsk, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Saint Petersburg, , Russian Federation
Singapore, Central Singapore, Singapore
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Sabadell, Barcelona, Spain
Las Palmas De Gran Canaria, Canarias, Spain
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Girona, , Spain
Granada, , Spain
Madrid, , Spain
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Málaga, , Spain
Salamanca, , Spain
Chiayi City, Chiayi, Taiwan
Ankara, , Turkey
London, , United Kingdom
Oxford, , United Kingdom
Seoul, , Korea, Republic Of
South Bend, Indiana, United States
Saint Petersburg, , Russian Federation
Canton, Ohio, United States
Tbilisi, , Georgia
Halle (Saale), Sachsen Anhalt, Germany
Pulau Pinang, Georgetown, Malaysia
Kempten, Rheinland Pfalz, Germany
Taichung City, , Taiwan
Greenville, South Carolina, United States
Whittier, California, United States
Herston, Queensland, Australia
Badalona, Barcelona, Spain
Linz, Oberösterreich, Austria
Liege, Liège, Belgium
Haute Vienne, Limoges, France
Nice, Nice Cedex 3, France
Loire, Saint Priest En Jarez, France
Mannheim, Baden Württemberg, Germany
Beersheba, , Israel
Busan, Busan Gwang'yeogsi [Pusan Kwangyokshi], Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Málaga, Marbella, Spain
Adapazarı, , Turkey
Istanbul, , Turkey
Yenisehir/Mersin, , Turkey
Goyang Si, Gyeonggido, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
New Haven, Connecticut, United States
Moscow, Moskva, Russian Federation
East Syracuse, New York, United States
São Paulo, , Brazil
Paris, Le Kremlin Bicêtre, France
Biała Podlaska, , Poland
Baton Rouge, Louisiana, United States
Novosibirsk, Novosibirskaya Oblast', Russian Federation
Saint Petersburg, , Russian Federation
Saratov, , Russian Federation
Los Alamitos, California, United States
Mersin, Içel, Turkey
Novosibirsk, Novosibirskaya Oblast', Russian Federation
Maumee, Ohio, United States
Tacoma, Washington, United States
Tbilisi, , Georgia
Székesfehérvár, , Hungary
Ravenna, , Italy
Rimini, , Italy
Daegu, Daegu Gwang'yeogsi [Taegu Kwan], Korea, Republic Of
Coimbra, , Portugal
Salamanca, , Spain
Clermont, Florida, United States
Reno, Nevada, United States
Saint Louis, Missouri, United States
Linz, , Austria
Liege, , Belgium
Fortaleza, , Brazil
Paris, , France
Nice, , France
Avignon Cedex, , France
Pierre Benite, , France
Paris, , France
Mannheim, , Germany
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Mersin, , Turkey
Covington, Louisiana, United States
Patients applied
Trial Officials
Faye Feller
Study Director
Geron Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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