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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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