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)
Extranodal NK/T-cell lymphoma (ENKTL)
Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
Hodgkin lymphoma (HL)
Post-transplant lymphoproliferative disorder (PTLD)
HIV-associated lymphomas (Plasmablastic, Burkitt, Hodgkin, DLBCL)
EBV+ lymphoproliferative disorders other than the above

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
EBV+ DLBCL, NOS: Must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy
PTLD: Must have received immunotherapy with an anti-CD20 agent.
Hodgkin lymphoma: Must have received at least one course of anthracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
For ENKTL and PTCL patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. ENKTL patients must have failed an asparaginase-containing regimen.
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 Lugano 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 18 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 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 More Info
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
Norton Cancer Institute
Louisville Kentucky, 40241, United States More Info
University of Maryland Medical Center
Baltimore Maryland, 21201, 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 More Info
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14203, United States More Info
Icahn School of Medicine at Mount Sinai
New York New York, 10029, 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
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
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 More Info
Hôpital Saint-Eloi
Montpellier Cedex 5 Provence Alpes Cote d'Azur, , France More Info
Centre Hospitalier Lyon-Sud
Pierre-Bénite Rhone-Alps, , 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 More Info
Universitatsmedizin Mannheim
Mannheim , , Germany 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
Keimyung University Dongsan Hospital
Daegu Gyeongsangbugdo, , Korea, Republic of More Info
Inje University Busan Paik Hospital
Busan , , Korea, Republic of More Info
Kyungpook National University Hospital
Daegu , , Korea, Republic of More Info
Gachon University Gil Medical Center
Incheon , , Korea, Republic of More Info
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , , Korea, Republic of More Info
National Cancer Centre Singapore
Singapore , , Singapore More Info
Oncocare Cancer Center
Singapore , , Singapore More Info
Singapore General Hospital
Singapore , , Singapore More Info
Hospital Universitario 12 de Octubre
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
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan City , , Taiwan More Info
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool , , 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.

How clear is this clinincal trial information?

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