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Studies

Interventional Recruiting Phase 2

NCT05980806 on ClinicalTrials.gov

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

  • Sponsor: Karyopharm Therapeutics (United States)
  • Enrollment: 58 (Estimated)
  • Study start: 2024-04-22 (Actual)
  • Primary completion: 2027-06-01 (Estimated)
  • Study completion: 2028-10-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.

Conditions

  • Myelofibrosis
  • Moderate Thrombocytopenia
  • Mild Thrombocytopenia

Intervention / Treatment

  • Drug: Selinexor 60 mg
  • Drug: Selinexor 40 mg
  • Drug: Ruxolitinib
  • Drug: Pacritinib
  • Drug: Momelotinib

Primary Outcome Measures

  • Proportion of Participants with Spleen Volume Reduction ≥35% (SVR35) at Week 24 (At Week 24)
    Measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan by Investigator assessment.

Countries

Belgium, Bulgaria, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom, United States

Locations and Investigators

  • City of Hope - Duarte Main Site, Duarte, United States (Recruiting)
    • Haris Ali
    • Haris Ali (Principal Investigator)
  • Maryland Oncology Hematology - Independent of SCRI/ US Oncology, Columbia, United States (Recruiting)
    • Mohit Narang
    • Mohit Narang (Principal Investigator)
  • Weill Cornell Medicine NewYork-Presbyterian, New York, United States (Recruiting)
    • Ellen Ritche
    • Ellen Ritche (Principal Investigator)
  • Duke University, Durham, United States (Recruiting)
    • Lindsay Rein
    • Lindsay Rein (Principal Investigator)
  • Cleveland Clinic, Cleveland, United States (Recruiting)
    • Aaron Gerds
    • Aaron Gerds (Principal Investigator)
  • MD Anderson, Houston, United States (Recruiting)
    • Prithviraj Bose
    • Prithviraj Bose (Principal Investigator)
  • Huntsman Cancer Institute, Salt Lake City, United States (Recruiting)
    • Srinivas Tantravahi
    • Srinivas Tantravahi (Principal Investigator)
  • UZ Gent, Ghent, Belgium (Recruiting)
    • Dominiek Mazure
    • Dominiek Mazure (Principal Investigator)
  • UZ Leuven - Campus Gasthuisberg, Leuven, Belgium (Recruiting)
    • Timothy Devos
    • Timothy Devos (Principal Investigator)
  • University Multiprofile Hospital for Active Treatment Sveti George - Base 1, Plovdiv, Bulgaria (Recruiting)
    • Zhanet Grudeva-Popova
    • Zhanet Grudeva-Popova (Principal Investigator)
  • University Hospital Sv.Ivan Rilski - Sofia, Sofia, Bulgaria (Recruiting)
    • Atanas Radinoff
    • Atanas Radinoff (Principal Investigator)
  • University Multiprofile Hospital for Active Treatment Aleksandrovska, Sofia, Bulgaria (Recruiting)
    • Evgueniy Hadjiev
    • Evgueniy Hadjiev (Principal Investigator)
  • Specialized Hospital for Active Treatment of Hematological Diseases - EAD Sofia, Sofia, Bulgaria (Recruiting)
    • Martin Donchev
    • Martin Donchev (Principal Investigator)
  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD Department of Clinical Hematology, Stara Zagora, Bulgaria (Recruiting)
    • Mariya Todorova
    • Mariya Todorova (Principal Investigator)
  • Research Institute of the McGill University Health Centre, Montreal, Canada (Recruiting)
    • Jonathan How
    • Jonathan How (Principal Investigator)
  • Fakultní nemocnice Olomouc, Olomouc, Czechia (Recruiting)
    • Antonín Hluší
    • Antonín Hluší (Principal Investigator)
  • Aarhus Universitetshospital, Aarhus N, Denmark (Recruiting)
    • Peter Buur van Kooten Niekerk
    • Peter Buur van Kooten Niekerk (Principal Investigator)
  • Institut Bergonié, Bordeaux, France (Recruiting)
  • Centre Hospitalier Lyon-Sud, Pierre-Bénite, France (Recruiting)
    • Fiorenza Barraco
    • Fiorenza Barraco (Principal Investigator)
  • CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire, Tours, France (Recruiting)
    • Antoine Machet
    • Antoine Machet (Principal Investigator)
  • Chu De Nîmes - Institut De Cancérologie Du Gard, Nîmes, France (Recruiting)
    • Stefan Wickenhauser
    • Stefan Wickenhauser (Principal Investigator)
  • Centre Hospitalier Universitaire d'Angers, Angers, France (Recruiting)
    • Françoise Boyer-Perrard
    • Françoise Boyer-Perrard (Principal Investigator)
  • Hôpital Saint-Louis, Paris, France (Recruiting)
    • Jean-Jacques Kiladjian
    • Jean-Jacques Kiladjian (Principal Investigator)
  • Hôpital Cochin, Paris, France (Recruiting)
    • Lise Willems
    • Lise Willems (Principal Investigator)
  • Centre Hospitalier Universitaire de Saint-Etienne, Saint-Priest-en-Jarez, France (Recruiting)
    • Philippe Renaudier
    • Philippe Renaudier (Principal Investigator)
  • Marien Hospital Düsseldorf, Düsseldorf, Germany (Recruiting)
    • Stefanie Groepper (Principal Investigator)
  • University Hospital Jena, Jena, Germany (Recruiting)
    • Carl Crodel
    • Carl Crodel (Principal Investigator)
  • Laiko General Hospital of Athens, Athens, Greece (Recruiting)
    • Panayiotis Panayiotidis
    • Panayiotis Panayiotidis (Principal Investigator)
  • University General Hospital Attikon, Athens, Greece (Recruiting)
    • Panagiotis Tsirigotis
    • Panagiotis Tsirigotis (Principal Investigator)
  • "Georgios Papanikolaou" General Hospital of Thessaloniki, Thessaloniki, Greece (Recruiting)
    • Damianos Sotiropoulos
    • Damianos Sotiropoulos (Principal Investigator)
  • University General Hospital of Ioannina, Hematology Department, Ioannina, Greece (Recruiting)
    • Eleftheria Hatzimichael
    • Eleftheria Hatzimichael (Principal Investigator)
  • University General Hospital of Larissa, Hematology Department, Larissa, Greece (Recruiting)
    • George Vassilopoulos
    • George Vassilopoulos (Principal Investigator)
  • Semmelweis Egyetem, Budapest, Hungary (Recruiting)
    • Zsolt Nagy
    • Zsolt Nagy (Principal Investigator)
  • Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (Recruiting)
    • Ilya Kirgner
    • Ilya Kirgner (Principal Investigator)
  • Rambam Health Care Campus, Haifa, Israel (Recruiting)
    • Noa Lavi
    • Noa Lavi (Principal Investigator)
  • Carmel Medical Center, Haifa, Israel (Recruiting)
    • Elena Mishchenko
    • Elena Mishchenko (Principal Investigator)
  • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Milan, Italy (Recruiting)
    • Alessandra Iurlo
    • Alessandra Iurlo (Principal Investigator)
  • Hematology Division, Mauriziano Hospital, University of Turin, Orbassano, Italy (Recruiting)
    • Daniela Cilloni
    • Daniela Cilloni (Principal Investigator)
  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino, Torino, Italy (Recruiting)
    • Eloise Beggiato
    • Eloise Beggiato (Principal Investigator)
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy (Recruiting)
    • Francesca Palandri
    • Francesca Palandri (Principal Investigator)
  • IRCCS Ospedale Policlinico San Martino, Genova, Italy (Recruiting)
    • Roberto Lemoli
    • Roberto Lemoli (Principal Investigator)
  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST, Meldola, Italy (Recruiting)
    • Alessandro Lucchesi
    • Alessandro Lucchesi (Principal Investigator)
  • Istituto Europeo di Oncologia, Milan, Italy (Recruiting)
    • Federica Gigli
    • Federica Gigli (Principal Investigator)
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, Italy (Recruiting)
    • Marianna Caramella
    • Marianna Caramella (Principal Investigator)
  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara, Novara, Italy (Recruiting)
    • Andrea Patriarca
    • Andrea Patriarca (Principal Investigator)
  • Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (Recruiting)
    • Elisa Rumi
    • Elisa Rumi (Principal Investigator)
  • Università Campus Bio-Medico di Roma, Rome, Italy (Recruiting)
    • Luigi Rigacci
    • Luigi Rigacci (Principal Investigator)
  • Spaarne Gasthuis, Hoofddorp, Netherlands (Recruiting)
    • Aart Beeker
    • Aart Beeker (Principal Investigator)
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Lublin, Poland (Recruiting)
    • Krzysztof Giannopoulos
    • Krzysztof Giannopoulos (Principal Investigator)
  • AIDPORT, Skórzewo, Poland (Recruiting)
    • Michał Kwiatek
    • Michał Kwiatek (Principal Investigator)

And 20 other sites.