Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

421

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

December 13, 2019

Study Completion Date

December 13, 2022

Conditions
Peripheral T-cell Lymphoma
Interventions
DRUG

Romidepsin + CHOP

Ro-CHOP administered in 3 week cycles for 6 cycles or until progression Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.

DRUG

CHOP

CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles.

Trial Locations (131)

37044

CHU Bretonneau, Tours

59037

CHRU de Lille - Hôpital Claude Hurriez, Lille

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75743

Hôpital Necker, Paris

78157

Centre Hospitalier de Versailles - André Mignot, Le Chesnay

Unknown

ZNA Stuivenberg, Antwerp

A.Z. Sint Jan AV, Bruges

Institut Jules Bordet, Brussels

UCL Louvain Saint Luc, Brussels

ULB - Hôpital Erasme, Brussels

Grand Hôpital de Charleroi, Charleroi

Hôpital Jolimont, Haine-Saint-Paul

AZ VUB, Jette

AZ Groeninge, Kortrijk

CHC - Clinique Saint Joseph, Liège

CHU de Liege, Liège

CHU Mont Godinne, Yvoir

CHU d'Amiens, Amiens

CHU d'Angers, Angers

CH de Annecy, Annecy

CH Henri Duffaut, Avignon

CH Côte Basque, Bayonne

CHU Jean Minjoz, Besançon

CH de Béziers, Béziers

CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie, Bordeaux

Institut Bergonié, Bordeaux

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

CH du Dr Duchenne, Boulogne-sur-Mer

CH de Bourg en Bresse, Bourg-en-Bresse

Centre François Baclesse, Caen

Institut d'Hématologie de Basse-Normandie, Caen

CH de Chalon sur Saône, Chalon-sur-Saône

CH de Chambéry, Chambéry

Hôpital Antoine Béclère, Clamart

CHU Estaing, Clermont-Ferrand

Hôpital Pasteur, Colmar

CH Sud Francilien de Corbeil, Corbeil-Essonnes

CHU Henri Mondor, Créteil

CHU de Dijon, Dijon

CH de Dunkerque, Dunkirk

CHU de Grenoble, Grenoble

CHD La Roche sur Yon, La Roche-sur-Yon

Hôpital Kremlin Bicêtre, Le Kremlin-Bicêtre

CH du Mans, Le Mans

Clinique Victor Hugo, Le Mans

CH de Lens, Lens

CH de Saint Quentin, Lille

Hôpital Saint Vincent de Paul, Lille

CHU de Limoges, Limoges

Centre Léon Bérard, Lyon

CH de Saint Germain, Mantes-la-Jolie

Chi Poissy /Saint- Germain-En-Laye, Mantes-la-Jolie

Institut Paoli Calmettes, Marseille

CH de Meaux, Meaux

CHR de Metz, Metz

Hôpital Saint Eloi, Montpellier

CHU de Mulhouse, Mulhouse

CHU Nancy Brabois, Nancy

CHU Hôtel Dieu Nantes, Nantes

Centre Antoine Lacassagne, Nice

CHU de Nice, Nice

CHU de Nîmes - Caremeau, Nîmes

Hôpital de la Pitié Salpétrière, Paris

Hôpital Saint Antoine, Paris

Hôpital Saint Louis, Paris

Institut Curie, Paris

CH de Perpignan, Perpignan

Centre François Magendie, Pessac

CHU de Poitiers, Poitiers

CHU Robert Debré, Reims

CHU Pontchaillou, Rennes

CH de Roubaix, Roubaix

Centre Henri Becquerel, Rouen

Institut Curie - Centre René Huguenin, Saint-Cloud

CHU de Toulouse, Toulouse

CH Valence, Valence

CH de Valenciennes, Valenciennes

CH de Bretagne Atlantique, Vannes

Institut Gustave Roussy, Villejuif

Charité Medical School Campus Benjamin Franklin, Berlin

Charité Medical School Campus Virchow-Klinikum, Berlin

HELIOS Hospital Berlin-Buch, Berlin

Vivantes Klinikum Neukölln, Berlin

Uniklinik Köln, Cologne

St Johannes-Hospital, Dortmund

Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden

Klinik Universitätsklinikum Düsseldorf, Düsseldorf

University of Duisburg-Essen, Essen

Krankenhaus Nordwest, Frankfurt am Main

Universitätklinikum Freiburg Klinik für Innere medizin I, Freiburg im Breisgau

UniversitätsKrebszentrum Göttingen - G-CCC, Göttingen

Universitätsmedizin Greifswald, Greifswald

Asklepios Klinik St. Georg, Hamburg

Universitätsklinikum des Saarlandes, Homburg

Klinikum St. Georg gGmbH, Leipzig

Klinikum Oldenburg gGmbH, Oldenburg

Universitätsklinikum Ulm, Ulm

"Istituto di Ematologia Saragnoli Policlinico San'Orsola-Malpighi, Bologna", Bologna

Azienda Ospedaliera Spedali Civili di Brescia, Brescia

Ospedale Ferrarotto, Catania

Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo, Cuneo

Azienda Ospedaliera universitaria Careggi, Florence

Ematologia Oncologica Istituto Pascale, Napoli

Azienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria

Ematologia Università La Sapienza, Roma

AOU San Giovanni Battista, Torino

Clinica Ematologica di Udine, Udine

Instituto Português Oncologia, Lisbon

National Cancer Centre Singapore, Singapore

National University Cancer Hospital, Singapore

Singapore General Hospital, Singapore

Dong-A Univ. Hospital, Busan

National Cancer Center, Goyang-si

Asian Medical Center, Seoul

Korean Cancer Center Hospital, Seoul

Samsung Medical Center, Seoul

Severance Hospital Yonsei University, Seoul

Hospital Clínic de Barcelona, Barcelona

Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital del Mar, Barcelona

ICO l'Hospitalet, Barcelona

ICO - Institut Català d'Oncologia - Hospital Doctor Josep Trueta, Girona

Hospital de Jerez de la Frontera, Jerez de la Frontera

Hospital Universitario 12 de Octubre, Madrid

H. Morales Messeguer, Murcia

Hospital Universitario Central de Asturias, Oviedo

Hospital Clínico Universitario de Salamanca, Salamanca

H. Virgen del Rocío, Seville

Hospital Arnau de Vilanova de Valencia, Valencia

Hospital Universitario Dr. Peset de Valencia, Valencia

Hospital Clinico Universitario de Valladolid, Valladolid

All Listed Sponsors
lead

The Lymphoma Academic Research Organisation

OTHER

NCT01796002 - Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma | Biotech Hunter | Biotech Hunter