EBV-Positive DLBCL, NOS Clinical Trial
— NAVAL-1Official title:
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 2026 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Australia | Box Hill Hospital | Melbourne | Victoria |
Australia | The Alfred Hospital | Melbourne | Victoria |
Brazil | 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 | |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Hôpital Maisonneuve-Rosemont | Montréal | Quebec |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Canada | BC Cancer Agency | Vancouver | British Columbia |
France | Institut Bergonié | Bordeaux Cedex | Aquitaine |
France | Centre Hospitalier Départemental Vendée | La Roche-sur-Yon | Pays De La Loire |
France | Centre Hospitalier Universitaire Limoges | Limoges cedex | Limousin |
France | Paoli-Calmettes Institute | Marseille | |
France | Hôpital Saint-Eloi | Montpellier Cedex 5 | Provence Alpes Cote d'Azur |
France | Henri Mondor University Hospital | Paris | |
France | Hôpital Universitaire Pitié Salpêtrière | Paris | Ile-de-France |
France | Hôpital Haut-Lévêque | Pessac | Nouvelle-Aquitaine |
France | Centre Hospitalier Lyon-Sud | Pierre-Bénite | Rhone-Alps |
Germany | Evangelisches Diakonie Hospital (DIAKO) | Bremen | |
Germany | Klinikum Chemnitz | Chemnitz | Saxony |
Germany | Universitätsklinikum Essen | Essen | Nordrhein-Westfalen |
Germany | Martin-Luther-Universität | Halle | |
Germany | Universitätsklinikum Leipzig | Leipzig | |
Germany | Universitatsmedizin Mannheim | Mannheim | |
Germany | Klinikum Oldenburg | Oldenburg | Niedersachsen |
Germany | Universitätsklinikum Würzburg | Würzburg | Bavaria |
Hong Kong | Queen Mary Hospital/University of Hong Kong | Hong Kong | |
Israel | Hadassah Medical Center, Ein Kerem Hospital | Jerusalem | |
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 | Istituto Clinico Humanitas | Rozzano | Milan |
Italy | Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia |
Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
Korea, Republic of | Keimyung University Dongsan Hospital | Daegu | Gyeongsangbugdo |
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 | |
Malaysia | University of Malaya | Kuala Lumpur | |
Malaysia | Sarawak General Hospital / Hospital Umum Sarawak | Kuching | |
Singapore | National Cancer Centre Singapore | Singapore | |
Singapore | Oncocare Cancer Center | Singapore | |
Singapore | Singapore General Hospital | Singapore | |
Spain | Hospitalet de Llobregat | Barcelona | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Jimenez Diaz Foundation University Hospital | Madrid | |
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 | Mackay Memorial Hospital - Taipei | Taipei | |
Taiwan | National Taiwan University Hospital | Taipei City | |
Taiwan | Taipei Veterans General Hospital | Taipei City | Taipei |
Taiwan | Chang Gung Memorial Hospital - Linkou Branch | Taoyuan City | |
United Kingdom | 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 States | University of Michigan Health System | Ann Arbor | Michigan |
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | University of Colorado Cancer Center | Aurora | Colorado |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | St. Vincent Healthcare Cancer Center | Billings | Montana |
United States | The University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Roswell Park Comprehensive Cancer Center | Buffalo | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Ohio State University: Wexner Medical Center | Columbus | Ohio |
United States | Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas |
United States | City of Hope | Duarte | California |
United States | Duke Cancer Institute | Durham | North Carolina |
United States | John Theurer Cancer Center: Hackensack Univeristy | Hackensack | New Jersey |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | David Geffen School of Medicine - UCLA | Los Angeles | California |
United States | Norton Cancer Institute | Louisville | Kentucky |
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 | University of California Irvine | Orange | California |
United States | Mid Florida Hematology and Oncology Center | Orange City | Florida |
United States | Sidney Kimmel Cancer Center - Jefferson Health | Philadelphia | Pennsylvania |
United States | Scripps MD Anderson Cancer Center | San Diego | California |
United States | UCSF Hematology and Blood and Marrow Transplant | San Francisco | California |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | The Oncology Institute of Hope and Innovation | Torrance | California |
United States | University of Arizona Cancer Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Viracta Therapeutics, Inc. |
United States, Australia, Brazil, Canada, France, Germany, Hong Kong, Israel, Italy, Korea, Republic of, Malaysia, Singapore, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) | Assessed by an Independent Review Committee (IRC) per the 2007 International Working Group Response Criteria (IWGRC) | Approximately 3 years | |
Secondary | Duration of response (DOR) | Approximately 3 years | ||
Secondary | Time to next anti-lymphoma treatment (TTNLT) | Approximately 3 years | ||
Secondary | Progression-free survival (PFS) | Approximately 3 years | ||
Secondary | Time to progression (TTP) | Approximately 3 years | ||
Secondary | Overall survival | Approximately 3 years | ||
Secondary | Incidence and severity of treatment-emergent adverse events | Approximately 28 days following the last dose | ||
Secondary | Pharmacokinetic parameter - time to maximum plasma concentration [tmax], | Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) | ||
Secondary | Pharmacokinetic parameter - maximum plasma concentration [Cmax] | Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) | ||
Secondary | Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC] | Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days) |
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