Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients With Intermediate-2 or High-risk Myelofibrosis (MF) Relapsed / Refractory (R/R) to Janus Kinase (JAK) Inhibitor
Study ID: NCT04576156
Conditions
Study Description
Brief Summary: The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment.
Detailed Description: This is a multicenter study with 2 arms, and will include 3 phases: a) screening phase of up to 28 days before randomization during which participants will complete a 14-day washout period from all prior therapies including JAK-inhibitor treatment, and the participant's eligibility will be reviewed; b) treatment phase, from randomization until study treatment (imetelstat or BAT) discontinuation; and c) post treatment follow-up phase, that begins when the participant discontinues treatment, and will continue until death, lost to follow-up, withdrawal of consent, or study end, whichever occurs first. Participants will be randomized (2:1) into 2 Arms (Arm A will receive imetelstat and Arm B will receive BAT). Participants who meet progressive disease criteria and discontinue BAT, may crossover to receive imetelstat treatment after sponsor's approval.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology, Fayetteville, Arkansas, United States
University of California-San Diego/Moores UCSD Cancer Center, La Jolla, California, United States
Memorial Care, Long Beach, California, United States
UCLA david geffen school of medicine, Los Angeles, California, United States
Sharp HealthCare, San Diego, California, United States
The Oncology Institute - Innovative Clinical Research Institute (ICRI), Whittier, California, United States
Hartford Healthcare, Hartford, Connecticut, United States
Smilow Cancer Center at YNHH, New Haven, Connecticut, United States
BRCR Medical Center Inc, Plantation, Florida, United States
University of South Florida, Tampa, Florida, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Goshen Center for Cancer Care, Goshen, Indiana, United States
Beacon Health System, South Bend, Indiana, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Maryland Oncology Hematology, Rockville, Maryland, United States
Oncology Hematology Associates, Springfield, Missouri, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Hematology-Oncology Associates of Central New York (HOACNY), East Syracuse, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Aultman Medical Group, Canton, Ohio, United States
Gabrail Cancer Center, Canton, Ohio, United States
Ohio Health, Columbus, Ohio, United States
Cancer Care Associates of York, York, Pennsylvania, United States
Bon Secours (Greenville) - St. Francis Cancer Center, Greenville, South Carolina, United States
Sanford Health, Sioux Falls, South Dakota, United States
Prairie Lakes Health Care System, Inc., Watertown, South Dakota, United States
The University of Texas MD, Houston, Texas, United States
Oncology Consultants, Houston, Texas, United States
Community Cancer Trials of Utah, Ogden, Utah, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Northwest Medical Specialties PLLC, Tacoma, Washington, United States
Hospital Aleman, Ciudad de Buenos Aires, Buenos Aires, Argentina
Sanatorio de la Mujer, Rosario, Santa Fe, Argentina
Sanatorio Allende, Córdoba, , Argentina
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Epworth Healthcare, Richmond, Victoria, Australia
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel, Wein, Burgenland, Austria
Krankenhaus der Elisabethinen, Linz, Oberösterreich, Austria
Kepler Universitätsklinikum Gm, Linz, Oberösterreich, Austria
Klinikum Wels-Grieskirchen GmbH, Wels, Oberösterreich, Austria
UZ Antwerpen, Edegem, Antwerpen, Belgium
Centre Hospitalier de Jolimont, Haine-Saint-Paul, Hainaut, Belgium
CHU De Liège, Liege, Liège, Belgium
Universitair Ziekenhuis Gent, Gent, Oost-Vlaanderen, Belgium
Zna - Campus Middelheim, Antwerpen, , Belgium
ZNA Stuyvenberg Antwerpen, Antwerpen, , Belgium
AZ Klina, Antwerpen, , Belgium
Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB), Jette, , Belgium
Centro de oncologia Leonardo da Vinci, Fortaleza, Ceará, Brazil
Hospital das Clínicas UFG, Goiânia, Goiás, Brazil
Hospital Erasto Gaertner, Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre - UFRGS, Porto Alegre, Rio Grande Do Sul, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA, Porto Alegre, Rio Grande Do Sul, Brazil
CEPON Centro de Pesquisas Oncologicas SC, Florianópolis, , Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde, São Paulo, , Brazil
Hospital Israelita Albert Einstein, São Paulo, , Brazil
Fundacao Doutor Amaral Carvalho / Hospital Amaral Carvalho, São Paulo, , Brazil
Hospital A.C.Camargo Cancer Center - Clinical Oncology, São Paulo, , Brazil
UMHAT "Dr. Georgi Stranski", Pleven, , Bulgaria
UMBAL Sveti Georgi, Plovdiv, , Bulgaria
Specialized Hospital for Active Therapy of Hematological dis, Sofia, , Bulgaria
Oncologos del Occidente S.A, Pereira, Risaralda, Colombia
Hospital Pablo Tobon Uribe, Antioquia, , Colombia
Centro Medico Imbanaco de Cali S.A., Cali, , Colombia
FOSCAL, Floridablanca, , Colombia
Odense University Hospital - Hematology, Odense, , Denmark
Institut de cancérologie du Gard - Hematologie clinique, Nimes Cedex 09, Gard, France
CHU Bretonneau, Tours, Indre-et-Loire, France
Hopital Bicetre, Paris, Le Kremlin-Bicêtre, France
CHU de Limoges Dupuytren, Haute-Vienne, Limoges, France
CHU De Nantes - Hématologie C, Nantes, Loire-Atlantique, France
CHU de Nice - Hopital de l'Archet II - Pharmacie, Nice, Nice Cedex 3, France
Hospital CENTRE HOSPITALIER AVIGNON, Avignon cedex, Provence-Alpes-Côte-d'Azur, France
Centre Hospitalier Lyon, Pierre-benite, Rhône-Alpes, France
CHU de Saint Etienne, Loire, Saint Priest En Jarez, France
Centre Hospitalier Du Mans - Cancérologie Médicale, Le Mans, Sarthe, France
Hopital Avicenne - Hématologie Clinique, Bobigny, Seine-Saint-Denis, France
CHRU Brest - Hôpital Morvan, Brest cedex, , France
CHU - Hôpital Saint Louis - Centre D'Investigations Cliniq, Paris, , France
Hopital Cochin - Aphp Hôpitaux Universitaires Paris Centre, Paris, Île-de-France, France
LTD Israeli-Georgian Medical R, Tbilisi, , Georgia
M.Zodelava Hematology Center L, Tbilisi, , Georgia
J.S.C."K.Eristavi National Cen, Tbilisi, , Georgia
Multi Profile Clinic Consilium, Tbilisi, , Georgia
Ltd "Medinvest" Institute of H, Tbilisi, , Georgia
Universitätsklinikum Mannheim - University of Heidelberg, Mannheim, Baden-Württemberg, Germany
Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany
Universitätsklinikum Carl Gust, Dresden, Hamburg, Germany
Klinikum Kempten-Oberallgaeu GmbH, Kempten, Rheinland-Pfalz, Germany
Martin-Luther-Universität Halle-Wittenberg, Halle (Saale), Sachsen-Anhalt, Germany
Universitätsklinikum Leipzig AöR, Leipzig, Sachsen, Germany
Universitätsklinikum Schleswig, Kiel, Schleswig-Holstein, Germany
Semmelweis Egyetem - III. sz., Budapest, , Hungary
Dél-pesti Centrumkórház Ország, Budapest, , Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András, Nyíregyháza, , Hungary
Fejer Megyei Szent Gyorgy Egye, Székesfehérvár, , Hungary
All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences), New Delhi, Delhi, India
Sir Ganga Ram Hospital, New Delhi, Delhi, India
Nirmal Hospital - Hematology, Surat, Gujarat, India
St. John's Medical College Hospital, Bangalore, Karnataka, India
Fortis Hospital 154/9, Bengaluru, Karnataka, India
Fortis Memorial Research Institute, Gurgaon, New Delhi, India
All India Institute of Medical Sciences, Bhubaneswar, Orissa, India
Nilratan Sircar Medical College, Kolkata, West Bengal, India
Narayana Hrudayalaya Hospital, Hyderabad, , India
Deenanath Mangeshkar Hospital & Research Center, Pune, , India
Sahyadri Specialty Hospital, Pune, , India
Assuta Ashdod University Hospi, Ashdod, HaDarom, Israel
Barzilai Medical Center, Ashkelon, HaDarom, Israel
Kaplan Medical Center, Rehovot, HaMerkaz, Israel
Shamir Medical Center (Assaf Harofeh), Zerifin, HaMerkaz, Israel
Western Galilee Hospital - Nahariya, Nahariya, HaZafon, Israel
Tel Aviv Sourasky Medical Cent, Tel Aviv, Tel-Aviv, Israel
Hadassah Medical Organization, Jerusalem, Yerushalayim, Israel
Soroka Medical Center - Hematology Institute, Beersheba, , Israel
Bnai Zion Medical Center, Haifa, , Israel
Carmel MC, Haifa, , Israel
Arcispedale S.Anna - Ematologi, Cona, Ferrara, Italy
Istituto Clinico Humanitas Roz, Rozzano, Milano, Italy
AOU San Luigi Gonzaga, Orbassano, Torino, Italy
PO Civile SS.Antonio e Biagio, Alessandria, , Italy
A.O.di Bologna Policl.S.Orsola, Bologna, , Italy
Presidio Ospedaliero Garibaldi, Catania, , Italy
AOU Careggi, Firenze, , Italy
IRCCS Ospedale Policlinico San Martino, Genova, , Italy
Clinica Ematologica, Univ. Deg, Genova, , Italy
Irccs Irst, Meldola, , Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, , Italy
Ospedale San Raffaele, Milano, , Italy
ASST Grande Ospedale Metropoli, Milano, , Italy
Azienda Ospedaliera San Gerard, Monza, , Italy
AOU Federico II, Napoli, , Italy
Ospedale Civile S.Maria delle, Ravenna, , Italy
Arcispedale S Maria Nuova, AO di Reggio Emilia, Reggio Calabria, , Italy
Azienda Ospedaliera Bianchi-Me, Reggio Calabria, , Italy
AUSL di Rimini Ospedale Inferm, Rimini, , Italy
ASL Roma 2 - PO "S. Eugenio", Roma, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
AOU Città della Salute e della Scienza di Torino, Torino, , Italy
Ospedale di Circolo, PO Varese, Varese, , Italy
Ospedale S.Bortolo, AULSS n.6, Vicenza, , Italy
Inje University Busan Paik Hos, Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], Korea, Republic of
Inje University Haeundae Paik Hospital, Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], Korea, Republic of
Kyungpook National University, Daegu, Daegu Gwang'yeogsi [Taegu-Kwan], Korea, Republic of
National Cancer Institute Center for Cancer Research, Goyang-Si, Gyeonggido, Korea, Republic of
Gachon University Gil Medical Center, Incheon, Incheon Gwang'yeogsi [Inch'n-Kwangyokshi], Korea, Republic of
Korea University Anam Hospital, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Korea University Guro Hospital, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], Korea, Republic of
Seoul National University Hospital - Department of Internal, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Pusan National University Hospital - Hematology and Oncology, Busan, , Korea, Republic of
The Catholic University of Korea, Seongdong, , Korea, Republic of
Severance Hospital, Yonsei Uni, Seoul, , Korea, Republic of
Hospital Pulau Pinang, Pulau Pinang, Georgetown, Malaysia
Hospital Sultanah Aminah Johor Bahru, Johor Bahru, Johor, Malaysia
Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, Malaysia
Sarawak General Hospital, Kuching, Sarawak, Malaysia
Hospital Ampang, Ampang, Selangor, Malaysia
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Sl, Slupsk, Pomorskie, Poland
Ars Medical Sp. z o.o., Piła, Wielkopolskie, Poland
Centrum Medyczne Pratia Poznan, Skorzewo, Wielkopolskie, Poland
Wojewodzki Szpital Specjalistyczny, Biała Podlaska, , Poland
Pratia Onkologia Katowice, Katowice, Śląskie, Poland
CCA-Braga. Centro Clínico Académico - Hospital Braga, Braga, , Portugal
CHUC - Centro Hospitalar e Uni, Coimbra, , Portugal
Instituto Português de Oncologia de Lisboa, Lisboa, , Portugal
Centro Clinico Fundacao Champalimaud, Lisboa, , Portugal
H. São Francisco Xavier-Centro, Lisboa, , Portugal
H. Santa Maria. Centro Hospita, Lisboa, , Portugal
Instituto Portugues de Oncologia do Porto, Porto, , Portugal
MONIKI - Oncology, Moscow, Moskovskaya Oblast', Russian Federation
MUZ City Clinical Hospital # 2, Novosibirsk, Novosibirskaya Oblast', Russian Federation
Tula Regional Clinical Hospital, Tula, Tul'skaya Oblast', Russian Federation
Budgetary Healthcare Institution of Omsk Region, Omsk, , Russian Federation
V.A. Almazov National Medical Research Center, Saint Petersburg, , Russian Federation
First Saint-Petersburg State Medical University n., Saint-Petersburg, , Russian Federation
GOU VPO Saratov State Medical University n.a. V.I., Saratov, , Russian Federation
National University Cancer Institute (NCIS), Singapore, Central Singapore, Singapore
Singapore General Hospital, Singapore, Central Singapore, Singapore
Institut Català d'Oncologia-Ho, Badalona, Barcelona, Spain
C.S. Parc Tauli, Sabadell, Barcelona, Spain
Hospital Universitario de Gran, Las Palmas de Gran Canaria, Canarias, Spain
H. Comarcal Costa del Sol, Málaga, Marbella, Spain
H.U. Ribera de Alzira, Alzira, Valencia, Spain
H.G.U. Alicante, Alicante, , Spain
H. San Pedro de Alcántara, Cáceres, , Spain
ICO-Hospital Universitari de G, Girona, , Spain
Hospital Universitario Virgen, Granada, , Spain
Hospital Universitario Fundaci, Madrid, , Spain
Hospital U. 12 Octubre, Madrid, , Spain
H.U. La Paz, Madrid, , Spain
H.U.V. de la Victoria, Málaga, , Spain
Complejo Asistencial Universit, Salamanca, , Spain
Hospital Universitario Doctor, Valencia, , Spain
H. Quirón Zaragoza, Zaragoza, , Spain
Chang Gung Medical Foundation, Chiayi City, Chiayi, Taiwan
China Medical University Hospital - Hematology/Onc, Taichung City, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Medical Park Mersin Hastanesi, Mersin, Içel, Turkey
Sakarya Research and Training Hospital - Medical Oncology, Adapazarı, , Turkey
Gazi University Medical Faculty, Ankara, , Turkey
Ankara University Medical Facu, Ankara, , Turkey
Istanbul Üniversitesi Cerrahpaşa, Istanbul, , Turkey
Medipol Bagcilar Mega Hospital, Istanbul, , Turkey
Marmara university pendik training and research hospital, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi, Izmir, , Turkey
Mersin University Medical Faculty, Yenisehir/Mersin, , Turkey
Maidstone Hospital, Maidstone, Kent, United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
Guys and St Thomas' Hospital, London, , United Kingdom
Oxford University Hospitals, Oxford, , United Kingdom
Contact Details
Name: Faye Feller
Affiliation: Geron Corporation
Role: STUDY_DIRECTOR
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