Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

June 3, 2021

Primary Completion Date

May 10, 2023

Study Completion Date

September 8, 2025

Conditions
Relapsed/Refractory Peripheral T-Cell LymphomaAdult T Cell Leukemia/Lymphoma
Interventions
DRUG

Valemetostat Tosylate

Oral administration of valemetostat tosylate at a dose of 200 mg once daily starting at Cycle 1, Day 1 (continuous for 28-day cycles), until disease progression or unacceptable toxicity

Trial Locations (60)

3121

Epworth Healthcare, Richmond

10002

National Taiwan University Hospital - Hematology And Oncology, Taipei

10065

Memorial Sloan-Kettering Cancer Center at Memorial Hospital, New York

Weill Cornell Medicine, New York

19104

University of Pennsylvania Perelman Center for Advanced Medicine, Philadelphia

20900

PO San Gerardo, ASST Monza, Monza

21079

CHU de Dijon, Dijon

24127

ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo, Bergamo

27710

Duke Cancer Center, Durham

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28046

Hospital Universitario La Paz, Madrid

30322

Emory University Hospital - Winship Cancer Institute, Atlanta

31100

Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole), Toulouse

33305

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology, Taoyuan

40138

A.O.di Bologna Policl.S.Orsola, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

55901

Mayo Clinic - Rochester, Rochester

59037

CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang, Lille

60611

Northwestern University - Feinberg School of Medicine, Chicago

63110

Washington University School of Medicine, St Louis

69008

Centre Lyon Berard - Medical Oncology, Lyon

69495

Centre Hospitalier Lyon Sud - Hématologie, Pierre-Bénite

70403

National Cheng Kung University Hospital - Internal Medicine, Tainan City

75010

APHP - Hopital Saint Louis, Paris

75015

Hôpital Necker, Paris

80045

University Of Colorado Cancer Center, Aurora

80131

Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori, Napoli

83301

Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology, Kaohsiung City

91010

City Of Hope National Medical Center, Duarte

94143

University of California San Francisco, San Francisco

94304

Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY, Palo Alto

02115

Dana Farber Cancer Institute, Boston

07601

Hackensack University Medical Center - John Theurer Cancer Center, Hackensack

V5Z 4E6

BC Cancer - Vancouver Centre, Vancouver

K1H 8L6

Ottawa Hospital Research Institute, Ottawa

M5G 1Z5

University Health Network Princess Margaret Hospital, Toronto

06120

Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV, Halle

06132

Ospedale S.Maria della Misericordia, AO di Perugia, Università degli Studi di Perugia, Perugia

460-0001

National Hospital Organization Nagoya Medical Center - Hematology, Nagoya

467-8602

Nagoya City University Hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa

060-8648

Hokkaido University Hospital - Medical Oncology Center, Sapporo

104-0045

National Cancer Center Hospital, Chuo Ku

812-0054

Kyushu University Hospital, Fukuoka

890-8520

Kagoshima University Hospital, Kagoshima

602-8566

University Hospital - Kyoto Prefectural University of Medicine, Kyoto

852-8501

Nagasaki University Hospital, Nagasaki

700-8558

Okayama University Hospital, Okayama

2333ZA

Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center), Leiden

6229 HX

Universiteit Maastricht Academisch Ziekenhuis Maastricht, Maastricht

03722

Severance Hospital, Yonsei University Health System, Seoul

03080

Seoul National University Hospital - Department of Internal, Seoul

05505

Asan Medical Center - Oncology, Seoul

06351

Samsung Medical Center - Hematology-Oncology, Seoul

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08029

ICO Hospital Duran i Reynals, Barcelona

08035

Hospital Universitario Vall d'Hebrón, Barcelona

NW1 2PG

University College London Hospital, London

NG5 1PB

Nottingham City Hospital - Clinical Haematology, Nottingham

OX3 7LE

Churchill Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY