Non Hodgkin Lymphoma Clinical Trial

An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

Summary

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

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Full 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:

EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)
Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
Post-transplant lymphoproliferative disorder (PTLD)
EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL)

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent.
For EBV+ PTLD patients: Relapsed/refractory disease following 1 prior therapy and must have received at least 1 course of an anti-CD20 immunotherapy. For patients with EBV+ PTLD only, age 12 years and older and weighing greater than 40 kg (Adolescent, Adult, Older Adult) are allowed
For other EBV+ relapsed/refractory lymphoma: Following at least 1 course of an anit-CD20 immunotherapy and at least 1 course of anthracycline-based chemotherapy (unless contraindicated)
No available therapies in the opinion of the Investigator
Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy
Measurable disease per Cheson 2007
ECOG performance status 0, 1, 2
Adequate bone marrow function

Key Exclusion Criteria:

Presence or history of CNS involvement by lymphoma
Systemic anticancer therapy or CAR-T within 21 days
Antibody (anticancer) agents within 28 days
Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant
Less than 90 days from prior allogeneic transplant.
Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1
Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT05011058

Recruitment Status:

Recruiting

Sponsor:

Viracta Therapeutics, Inc.

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There are 27 Locations for this study

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The University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35233, United States More Info
University of Arizona Cancer Center
Tucson Arizona, 85719, United States
City of Hope
Duarte California, 91010, United States More Info
David Geffen School of Medicine - UCLA
Los Angeles California, 90095, United States More Info
University of California Irvine
Orange California, 92868, United States More Info
Scripps MD Anderson Cancer Center
San Diego California, 92103, United States More Info
UCSF Hematology and Blood and Marrow Transplant
San Francisco California, 94143, United States More Info
The Oncology Institute of Hope and Innovation
Torrance California, 90503, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States More Info
Mid Florida Hematology and Oncology Center
Orange City Florida, 32763, United States More Info
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States More Info
Norton Cancer Institute
Louisville Kentucky, 40241, United States
University of Maryland Medical Center
Baltimore Maryland, 21201, United States More Info
University of Michigan Health System
Ann Arbor Michigan, 48105, United States More Info
St. Vincent Healthcare Cancer Center
Billings Montana, 59102, United States More Info
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03766, United States
John Theurer Cancer Center: Hackensack Univeristy
Hackensack New Jersey, 07601, United States More Info
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14203, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Memorial Sloan Kettering Cancer Center - New York
New York New York, 10065, United States More Info
Duke Cancer Institute
Durham North Carolina, 27710, United States More Info
Ohio State University: Wexner Medical Center
Columbus Ohio, 43210, United States More Info
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia Pennsylvania, 19107, United States More Info
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Harold C. Simmons Comprehensive Cancer Center
Dallas Texas, 75235, United States More Info
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States More Info
Box Hill Hospital
Melbourne Victoria, , Australia More Info
The Alfred Hospital
Melbourne Victoria, , Australia More Info
CEPEVILLE - Instituto Joinvilense de Hematologia e Oncologia
Joinville , , Brazil More Info
Ruschel Medicina e Pesquisa Clinica
Rio De Janeiro , , Brazil More Info
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André , , Brazil More Info
CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center
São Paulo , , Brazil More Info
HCFMUSP - Hospital das Clínicas da Faculdade de Medicina Universidade de São Paulo
São Paulo , , Brazil More Info
Cross Cancer Institute
Edmonton Alberta, , Canada More Info
BC Cancer Agency
Vancouver British Columbia, , Canada More Info
Princess Margaret Cancer Centre
Toronto Ontario, , Canada More Info
Hôpital Maisonneuve-Rosemont
Montréal Quebec, , Canada More Info
Institut Bergonié
Bordeaux Cedex Aquitaine, , France More Info
Hôpital Universitaire Pitié Salpêtrière
Paris Ile-de-France, , France More Info
Centre Hospitalier Universitaire Limoges
Limoges cedex Limousin, , France More Info
Hôpital Haut-Lévêque
Pessac Nouvelle-Aquitaine, , France More Info
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 More Info
Paoli-Calmettes Institute
Marseille , , France More Info
Henri Mondor University Hospital
Paris , , France More Info
Universitätsklinikum Würzburg
Würzburg Bavaria, , Germany More Info
Klinikum Oldenburg
Oldenburg Niedersachsen, , Germany More Info
Universitätsklinikum Essen
Essen Nordrhein-Westfalen, , Germany More Info
Klinikum Chemnitz
Chemnitz Saxony, , Germany
Evangelisches Diakonie Hospital (DIAKO)
Bremen , , Germany More Info
Martin-Luther-Universität
Halle , , Germany More Info
Universitätsklinikum Leipzig
Leipzig , , Germany More Info
Universitatsmedizin Mannheim
Mannheim , , Germany More Info
Queen Mary Hospital/University of Hong Kong
Hong Kong , , Hong Kong More Info
Hadassah Medical Center, Ein Kerem Hospital
Jerusalem , , Israel More Info
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo Foggia, , Italy More Info
Istituto Clinico Humanitas
Rozzano Milan, , Italy More Info
Centro di Riferimento Oncologico
Aviano Pordenone, , Italy More Info
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
Bologna , , Italy More Info
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia , , Italy More Info
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano , , Italy More Info
Istituto Europeo di Oncologia
Milano , , Italy More Info
Fondazione IRCCS Policlinico San Matteo
Pavia , , Italy More Info
Arcispedale Santa Maria Nuova
Reggio Emilia , , Italy More Info
Fondazione Policlinico Universitario Agostino Gemelli
Roma , , Italy More Info
Keimyung University Dongsan Hospital
Daegu Gyeongsangbugdo, , Korea, Republic of More Info
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 More Info
Samsung Medical Center
Seoul , , Korea, Republic of More Info
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
University of Malaya
Kuala Lumpur , , Malaysia More Info
Sarawak General Hospital / Hospital Umum Sarawak
Kuching , , Malaysia More Info
National Cancer Centre Singapore
Singapore , , Singapore More Info
Oncocare Cancer Center
Singapore , , Singapore More Info
Singapore General Hospital
Singapore , , Singapore More Info
Hospitalet de Llobregat
Barcelona , , Spain More Info
Hospital Universitario 12 de Octubre
Madrid , , Spain More Info
Jimenez Diaz Foundation University Hospital
Madrid , , Spain More Info
Taipei Veterans General Hospital
Taipei City Taipei, , Taiwan More Info
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , , Taiwan More Info
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , , Taiwan More Info
China Medical University Hospital
Taichung City , , Taiwan More Info
National Cheng Kung University Hospital
Tainan , , Taiwan More Info
National Taiwan University Hospital
Taipei City , , Taiwan More Info
Mackay Memorial Hospital - Taipei
Taipei , , Taiwan More Info
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan City , , Taiwan More Info
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool , , United Kingdom More Info
Kings College Hospital
London , , United Kingdom More Info
The Royal Marsden NHS Foundation Trust
London , , United Kingdom More Info
University College London Hospitals NHS Foundation Trust
London , , United Kingdom More Info
The Christie NHS Foundation Trust
Manchester , , United Kingdom More Info

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT05011058

Recruitment Status:

Recruiting

Sponsor:


Viracta Therapeutics, Inc.

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