An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
- Trial number:
- NCT05011058
- Trial phase:
- 2
- Study type:
- Targeted therapy
- Overall status:
- Recruiting
Study start date
May, 2021
Scientific title
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
Key
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
Study design
Primary purpose:
Treatment, Allocation:
N/A, Intervention model:
Single Group Assignment, Intervention model description:
This is an open-label, single-arm study utilizing a basket trial design., Masking:
None (Open Label),
Conditions
Epstein-Barr Virus Associated Lymphoproliferative Disorder, EBV-Related PTLD, EBV Related Non-Hodgkin's Lymphoma, EBV-Positive DLBCL, NOS, EBV Associated Lymphoma, EBV Related PTCL, NOS
Other study ID numbers
VT3996-202
Choose trial site (103)
The University of Alabama at Birmingham Comprehensive Cancer Center
1824 6th Ave S, Birmingham, AL 35233, USA
University of California Irvine
Irvine, CA 92697, USA
UCSF Hematology and Blood and Marrow Transplant
400 Parnassus Ave Fourth Floor, San Francisco, CA 94143, USA
The Oncology Institute of Hope and Innovation
21605 Hawthorne Blvd Suite 200, Torrance, CA 90503, USA
University of Colorado Cancer Center
1665 Aurora Court Anschutz Cancer Pavilion, Aurora, CO 80045, USA
Mid Florida Hematology and Oncology Center
2776 Enterprise Rd, Orange City, FL 32763, USA
University of Maryland Medical Center
22 S Greene St, Baltimore, MD 21201, USA
Roswell Park Comprehensive Cancer Center
665 Elm St, Buffalo, NY 14203, USA
Icahn School of Medicine at Mount Sinai
1 Gustave L. Levy Pl, New York, NY 10029, USA
Sidney Kimmel Cancer Center - Jefferson Health
233 S 10th St, Philadelphia, PA 19107, USA
Medical University of South Carolina
171 Ashley Ave Suite 419, MSC, # 403, Charleston, SC 29425, USA
The University of Texas MD Anderson Cancer Center
1515 Holcombe Blvd, Houston, TX 77030, USA
Cross Cancer Institute
11560 University Ave, Edmonton, AB T6G 1Z2, Canada
Princess Margaret Cancer Centre
610 University Ave, Toronto, ON M5G 2C1, Canada
Hôpital Maisonneuve-Rosemont
5415 Bd de l'Assomption, Montréal, QC H1T 2M4, Canada
Institut Bergonié
229 Cr de l'Argonne, 33000 Bordeaux, France
Hôpital Universitaire Pitié Salpêtrière
47-83 Bd de l'Hôpital, 75013 Paris, France
Centre Hospitalier Universitaire Limoges
2 Av. Martin Luther King, 87000 Limoges, France
Hôpital Haut-Lévêque
Av. du Haut Lévêque, 33604 Pessac, France
Centre Hospitalier Départemental Vendée
Centre Hospitalier Départemental Vendée, Bd Stéphane Moreau, 85000 La Roche-sur-Yon, France
Hôpital Saint-Eloi
80 Av. Augustin Fliche, 34090 Montpellier, France
Centre Hospitalier Lyon-Sud
165 Chem. du Grand Revoyet, 69310 Pierre-Bénite, France
Klinikum Oldenburg
Rahel-Straus-Straße 10, 26133 Oldenburg, Germany
Universitätsklinikum Essen
Hufelandstraße 55, 45147 Essen, Germany
Klinikum Chemnitz
Flemmingstraße 2, 09116 Chemnitz, Germany
Ospedale Casa Sollievo della Sofferenza
Viale Cappuccini, sn, 71013 San Giovanni Rotondo FG, Italy
Istituto Clinico Humanitas
Via Alessandro Manzoni, 56, 20089 Rozzano MI, Italy
Centro di Riferimento Oncologico
Via Franco Gallini, 2, 33081 Aviano PN, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
Via Giuseppe Massarenti, 9, 40138 Bologna BO, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Piazzale Spedali Civili, 1, 25123 Brescia BS, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Piazza dell'Ospedale Maggiore, 3, 20162 Milano MI, Italy
Istituto Europeo di Oncologia
Via Giuseppe Ripamonti, 435, 20141 Milano MI, Italy
Fondazione IRCCS Policlinico San Matteo
Viale Camillo Golgi, 19, 27100 Pavia PV, Italy
Arcispedale Santa Maria Nuova
Viale Risorgimento, 80, 42123 Reggio Emilia RE, Italy
Keimyung University Dongsan Hospital
1035 Dalgubeol-daero, Sindang-dong, Dalseo-gu, Daegu, South Korea
Inje University Busan Paik Hospital
75 Bokji-ro, Busanjin-gu, Busan, South Korea
Kyungpook National University Hospital
130 Dongdeok-ro, Samdeog-dong, Jung-gu, Daegu, South Korea
Gachon University Gil Medical Center
21 Namdong-daero 774beon-gil, Guwol-dong, Namdong-gu, Incheon, South Korea
Severance Hospital
50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
222 Banpo-daero, Banpo-dong, Seocho-gu, Seoul, South Korea
National Cancer Centre Singapore
11 Hospital Cres, Singapore 169610
Singapore General Hospital
31 Third Hospital Ave, Singapore 168753
Taipei Veterans General Hospital
No. 201, Section 2, Shipai Rd, Beitou District, Taipei City, Taiwan 112
Kaohsiung Chang Gung Memorial Hospital
No. 123號, Dapi Rd, Niaosong District, Kaohsiung City, Taiwan 833
Kaohsiung Medical University Chung-Ho Memorial Hospital
No. 100號, Ziyou 1st Rd, Sanmin District, Kaohsiung City, Taiwan 80756
China Medical University Hospital
No. 91號, Xueshi Rd, North District, Taichung City, Taiwan 404
National Cheng Kung University Hospital
No. 138號, Shengli Rd, North District, Tainan City, Taiwan 704
National Taiwan University Hospital
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
Chang Gung Memorial Hospital - Linkou Branch
No. 5, Fuxing St, Guishan District, Taoyuan City, Taiwan 333
Cardiff and Vale University Health Board
Heath Park, Cardiff CF14 4XW, UK
The Clatterbridge Cancer Centre NHS Foundation Trust
Clatterbridge Rd, Birkenhead, Wirral CH63 4JY, UK
University College London Hospitals NHS Foundation Trust
12 Queen Square, London WC1N 3BG, UK
The Christie NHS Foundation Trust
Wilmslow Rd, Manchester M20 4BX, UK
National Cancer Centre Singapore
University of Arizona Cancer Center
3838 N Campbell Ave, Tucson, AZ 85719, USA
Scripps MD Anderson Cancer Center
4060-4040 Fourth Ave, San Diego, CA 92103, USA
Norton Cancer Institute
4950 Norton Healthcare Blvd Suite 300, Louisville, KY 40241, USA
St. Vincent Healthcare Cancer Center
2223 Shiloh Rd, Billings, MT 59106, USA
Seattle Cancer Care Alliance
Seattle, WA 98109, USA
Universitätsklinikum Würzburg
Josef-Schneider-Straße 2, 97080 Würzburg, Germany
Oncocare Cancer Center
6 Napier Rd, #02-17/18/19 Gleneagles Medical Centre, Singapore 258499
Tan Tock Seng Hospital Singapore
David Geffen School of Medicine - UCLA
885 Tiverton Dr, Los Angeles, CA 90095, USA
Winship Cancer Institute of Emory University
1365 Clifton Rd Building C, Atlanta, GA 30322, USA
Dartmouth Hitchcock Medical Center
Lebanon, NH 03766, USA
John Theurer Cancer Center: Hackensack Univeristy
92 2nd St, Hackensack, NJ 07601, USA
Memorial Sloan Kettering Cancer Center - New York
1275 York Ave, New York, NY 10065, USA
Harold C. Simmons Comprehensive Cancer Center
6202 Harry Hines Blvd, Dallas, TX 75235, USA
BC Cancer Agency
Vancouver, BC, Canada
Paoli-Calmettes Institute
232 Bd de Sainte-Marguerite, 13009 Marseille, France
Henri Mondor University Hospital
1 Rue Gustave Eiffel, 94000 Créteil, France
University Hospital of Göttingen
Göttingen, Germany
Martin-Luther-Universität
06108 Halle (Saale), Germany
Universitatsmedizin Mannheim
Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
Fondazione Policlinico Universitario Agostino Gemelli
00168 Rome, Metropolitan City of Rome Capital, Italy
Hospitalet de Llobregat
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario 12 de Octubre
Av. de Córdoba, s/n, 28041 Madrid, Spain
Jimenez Diaz Foundation University Hospital
Av. de los Reyes Católicos, 2, 28040 Madrid, Spain
Mackay Memorial Hospital - Taipei
No. 92號, Section 2, Zhongshan N Rd, Zhongshan District, Taipei City, Taiwan 104
Chang Gung Memorial Hospital - Linkou Branch
No. 5, Fuxing St, Guishan District, Taoyuan City, Taiwan 333
Kings College Hospital
Denmark Hill, London SE5 9RS, UK
Duke Cancer Institute
2 Seeley Mudd, 10 Bryan Searle Drive, Durham, NC 27710, USA
Box Hill Hospital
8 Arnold St, Box Hill VIC 3128, Australia
The Alfred Hospital
55 Commercial Rd, Melbourne VIC 3004, Australia
Evangelisches Diakonie Hospital (DIAKO)
Gröpelinger Heerstraße 406-408, 28239 Bremen, Germany
Klinik für Innere Medizin, Uniklinik Köln
Kerpener Str. 62, 50937 Köln, Germany
Universitätsklinikum Leipzig
Liebigstraße 20, 04103 Leipzig, Germany
Queen Mary Hospital/University of Hong Kong
Queen Mary Hospital Main Block, Pok Fu Lam Rd, Pok Fu Lam, Hong Kong
Samsung Medical Center
81 Irwon-ro, Gangnam-gu, Seoul, South Korea
Ohio State University: Wexner Medical Center
410 W 10th Ave, Columbus, OH 43210, USA
CEPEVILLE - Instituto Joinvilense de Hematologia e Oncologia
3 - R. Dr. Plácido Gomes, 488 - Anita Garibaldi, Joinville - SC, 89202-050, Brazil
Ruschel Medicina e Pesquisa Clinica
R. Guilhermina Guinle, 151 - Botafogo, Rio de Janeiro - RJ, 22270-060, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Av. Príncipe de Gales, 821 - Vila Principe de Gales, Santo André - SP, 09060-650, Brazil
CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center
R. Prof. Antônio Prudente, 211 - Liberdade, São Paulo - SP, 01509-001, Brazil
HCFMUSP - Hospital das Clínicas da Faculdade de Medicina Universidade de São Paulo
Rua Francisco Dias Velho, 1058 - Vila Cordeiro, São Paulo - SP, 04581-001, Brazil
Klinik für Hämatologie und Onkologie, UKSH Campus Lübeck
Ratzeburger Allee 160, 23562 Lübeck, Germany
Hadassah Medical Center, Ein Kerem Hospital
Kalman Ya'akov Man St, Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Weizmann St 6, Tel Aviv-Yafo, Israel
University of Malaya
Universiti Malaya, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Sarawak General Hospital / Hospital Umum Sarawak
Jalan Hospital, 93586 Kuching, Sarawak, Malaysia
The Royal Marsden NHS Foundation Trust
Stewart's Grove, London SW3 6JJ, UK
City of Hope
1500 E Duarte Rd, Duarte, CA 91010, USA
University of Michigan Health System
1500 E Medical Center Dr, Ann Arbor, MI 48109, USA