Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Summary

The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.

Conditions

• Peripheral T-cell Lymphoma

Interventions

DRUG

Belinostat

Sponsors & Collaborators

• Valerio Therapeutics

  collaborator INDUSTRY

• Spectrum Pharmaceuticals, Inc

  lead INDUSTRY

Principal Investigators

• Peter Brown, MD · H:S Rigshospitalet, Department of Hematology, Denmark

• Pier L Zinzani, MD · Università di Bologna, Italy

• André Bosly, MD · Cliniques Universitaires UCL Mont Godinne, Belgium

• Georges Fillet, MD · University of Liege, Belgium

• Eric van den Neste, MD · Clinique Universitaier Saint Luc, Belgium

• Nicolas Monier, MD · Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France

• Elisabeth Perez, MD · Groupe Hospitalier Sud Réunion, France

• Maria Delioukina, MD · City of Hope National Medical Center, USA

• Adam Lerner, MD · Boston Medical Center, USA

• Lydia Dreosti, MD · Pretoria Academic Hospital, South Africa

• D. Moodley, MD · Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa

• Hanneke C. Kluin-Nelemans, MD · University Medical Center Groningen UMCG, The Netherlands

• G. Sissolak, MD · Tygerberg Hospital, Cape Town, South Africa

• L. Verdonk, MD · Isala Clinics, Zwolle, The Netherlands

• O. Visser, MD · VU Medical Center, Amsterdam, The Netherlands

• Owen A. O'Connor, MD · New York University Cancer Institute, USA

• Sarit Assouline, MD · McGill University, Department of Oncology Clinical Research Program, Montreal, Canada

• Juan Manuel Sancho Cia, MD · ICO Hospital Germans Trias i Pujol, Badalona, Spain

• Consolación Rayon, MD · Hospital Universitario Central de Asturias, Oviedo, Spain

• Sonia Gonzales, MD · Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain

• Lorenz Trümper, MD · Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany

• Andreas Viardot, MD · Universitätsklinikum Ulm, Ulm, Germany

• Georg Hess, MD · Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany

• Hans-Heinrich Wolf, MD · Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany

• Andreas Neubauer, MD · University Hospital Marburg, Marburg, Germany

• Michele Frank, MD · Cascade Cancer Center

• Madeleine Duvic, MD · UT - M. D. Anderson Cancer Center

• Andrei Shustov, MD · Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance

• Melissa Runge-Morris, MD · Barbara Ann Karmanos Cancer Institute

• Nalini Janakiraman, MD · Henry Ford Health System

• Amanda Cashen, MD · Wasington University School of Medicine- Division of Oncology

• Beata Holkova, MD · Massey Cancer Center

• Mohammad Tirgan, MD · Hematology Associates

• Bernard Poiesz, MD · Upstate Medical Univeristy Syracuse

• Charles Farber, MD · Morristown Memorial Hospital

• Zale Bernstein, MD · Erie County Medical Center (Roswell Park)

• Ralph Boccia, MD · Center for Cancers and Blood Disorders

• David Grinblatt, MD · Kellogg Cancer Care Center

• Laura Blakely, MD · Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)

• David Dennis, MD · Boca Raton Clinical Research Associates

• Fernando Camacho, MD · Bronx River Medical Associates, PC

• Eliot Epner, MD · Penn State Hershey Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-15

Primary Completion

2013-11-05

Completion

2014-10-27

FDA Drug

Yes

Countries

• United States
• Belgium
• Canada
• Croatia
• Denmark
• France
• Germany
• Hungary
• Israel
• Italy
• Netherlands
• Poland
• Russia
• Slovakia
• South Africa
• Spain
• United Kingdom

Study Locations