Spots Global Cancer Trial Database for An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
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Trial Identification
Brief Title: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Official Title: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Study ID: NCT05011058
Interventions
Study Description
Brief Summary: A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Detailed Description: Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas: 1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS) 2. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL 3. Post-transplant lymphoproliferative disorder (PTLD) 4. EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
David Geffen School of Medicine - UCLA, Los Angeles, California, United States
University of California Irvine, Orange, California, United States
Scripps MD Anderson Cancer Center, San Diego, California, United States
UCSF Hematology and Blood and Marrow Transplant, San Francisco, California, United States
The Oncology Institute of Hope and Innovation, Torrance, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
St. Vincent Healthcare Cancer Center, Billings, Montana, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
John Theurer Cancer Center: Hackensack Univeristy, Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center - New York, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Ohio State University: Wexner Medical Center, Columbus, Ohio, United States
Sidney Kimmel Cancer Center - Jefferson Health, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Box Hill Hospital, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
CEPEVILLE - Instituto Joinvilense de Hematologia e Oncologia, Joinville, , Brazil
Ruschel Medicina e Pesquisa Clinica, Rio De Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André, , Brazil
CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center, São Paulo, , Brazil
HCFMUSP - Hospital das Clínicas da Faculdade de Medicina Universidade de São Paulo, São Paulo, , Brazil
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Agency, Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hôpital Maisonneuve-Rosemont, Montréal, Quebec, Canada
Institut Bergonié, Bordeaux Cedex, Aquitaine, France
Hôpital Universitaire Pitié Salpêtrière, Paris, Ile-de-France, France
Centre Hospitalier Universitaire Limoges, Limoges cedex, Limousin, France
Hôpital Haut-Lévêque, Pessac, Nouvelle-Aquitaine, France
Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, Pays De La Loire, France
Hôpital Saint-Eloi, Montpellier Cedex 5, Provence Alpes Cote d'Azur, France
Centre Hospitalier Lyon-Sud, Pierre-Bénite, Rhone-Alps, France
Paoli-Calmettes Institute, Marseille, , France
Henri Mondor University Hospital, Paris, , France
Universitätsklinikum Würzburg, Würzburg, Bavaria, Germany
Klinikum Oldenburg, Oldenburg, Niedersachsen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Klinikum Chemnitz, Chemnitz, Saxony, Germany
Evangelisches Diakonie Hospital (DIAKO), Bremen, , Germany
Martin-Luther-Universität, Halle, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Universitatsmedizin Mannheim, Mannheim, , Germany
Queen Mary Hospital/University of Hong Kong, Hong Kong, , Hong Kong
Hadassah Medical Center, Ein Kerem Hospital, Jerusalem, , Israel
Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
Istituto Clinico Humanitas, Rozzano, Milan, Italy
Centro di Riferimento Oncologico, Aviano, Pordenone, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi, Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
Keimyung University Dongsan Hospital, Daegu, Gyeongsangbugdo, Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
University of Malaya, Kuala Lumpur, , Malaysia
Sarawak General Hospital / Hospital Umum Sarawak, Kuching, , Malaysia
National Cancer Centre Singapore, Singapore, , Singapore
Oncocare Cancer Center, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Hospitalet de Llobregat, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Jimenez Diaz Foundation University Hospital, Madrid, , Spain
Taipei Veterans General Hospital, Taipei City, Taipei, Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung City, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Mackay Memorial Hospital - Taipei, Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou Branch, Taoyuan City, , Taiwan
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
Kings College Hospital, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Donald (D.K.) Strickland, MD
Affiliation: Viracta Therapeutics
Role: STUDY_DIRECTOR
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