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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05011058
Other study ID # VT3996-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 28, 2021
Est. completion date December 2026

Study information

Verified date May 2024
Source Viracta Therapeutics, Inc.
Contact Strait Hicklin
Phone 858-400-8470
Email ClinicalTrials@Viracta.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nanatinostat in combination with valganciclovir
Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles Other name: VRx-3996 Drug: Valganciclovir, 900 mg orally once daily in 28 day cycles

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Viracta Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France,  Germany,  Hong Kong,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome

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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