Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Romidepsin CHOP (Ro-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma
1 other identifier
interventional
421
8 countries
131
Brief Summary
Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response Adjudication Committee (RAC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2013
Longer than P75 for phase_3
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 31, 2013
CompletedFirst Posted
Study publicly available on registry
February 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2022
CompletedJanuary 10, 2023
January 1, 2023
7 years
January 31, 2013
January 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint is Progression Free Survival
The primary efficacy endpoint is Progression Free Survival (PFS) using the response criteria for malignant lymphoma (1999) by a Response Adjudication Committee
60 months
Study Arms (2)
Experimental: Romidepsin plus CHOP
EXPERIMENTALPatients in experimental arm receive romidepsin plus CHOP (Ro-CHOP) administered in 3 week cycles for 6 cycles. Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.
Standard: CHOP
ACTIVE COMPARATORPatients in control Arm receive cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
Interventions
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.
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles.
Eligibility Criteria
You may qualify if:
- Males and females of 18 years of age to 80 years of age.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the World Health Organization (WHO) classification (2008;2011) may be included, whatever the Ann Arbor stage (I - IV):
- a. Nodal types: i. PTCL, not otherwise specified ii. Angioimmunoblastic T-cell lymphoma iii. Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK)-negative type
- b. Extra-nodal types: i. Enteropathy-associated T-cell lymphoma ii. Hepato-splenic T-cell lymphoma iii. Subcutaneous panniculitis-like T-cell lymphoma iv. Primary cutaneous gamma-delta T-cell lymphoma v. Primary cutaneous cluster of differentiation 8 positive (CD8+) aggressive epidermotropic lymphoma vi. Primary cutaneous cluster of differentiation 4 positive (CD4+) small/medium T-cell lymphoma
- c. Other non classifiable peripheral T-cell lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Negative pregnancy test for Females of ChildBearing Potential (FCBP)
- Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
- Life expectancy of ≥ 90 days (3 months).
You may not qualify if:
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
- Any condition that confounds the ability to interpret data from the study.
- Other types of lymphomas, e.g. B-cell lymphoma
- The following types of T cell lymphomas:
- Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
- Extranodal T-cell/Natural Killer (NK)-cell lymphoma, nasal type
- Anaplastic large cell lymphoma, ALK-positive type
- Cutaneous T cell lymphoma (mycosis fungoid, Sézary syndrome)
- Primary cutaneous cluster of differentiation antigen 30 positive (CD30+) T-cell lymphoproliferative disorder
- Primary cutaneous anaplastic T-cell lymphoma
- Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
- Previous radiotherapy for PTCL except if localized to one lymph node area
- Patients planned for autologous or allogeneic transplant as consolidation in first line
- Central nervous system -meningeal involvement
- Contraindication to any drug contained in the chemotherapy regimen,
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (131)
ZNA Stuivenberg
Antwerp, Belgium
A.Z. Sint Jan AV
Bruges, Belgium
Institut Jules Bordet
Brussels, Belgium
UCL Louvain Saint Luc
Brussels, Belgium
ULB - Hôpital Erasme
Brussels, Belgium
Grand Hôpital de Charleroi
Charleroi, Belgium
Hôpital Jolimont
Haine-Saint-Paul, Belgium
AZ VUB
Jette, Belgium
AZ Groeninge
Kortrijk, Belgium
CHC - Clinique Saint Joseph
Liège, Belgium
CHU de Liege
Liège, Belgium
CHU Mont Godinne
Yvoir, Belgium
CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
CH de Annecy
Annecy, France
CH Henri Duffaut
Avignon, France
CH Côte Basque
Bayonne, France
CHU Jean Minjoz
Besançon, France
CH de Béziers
Béziers, France
CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie
Bordeaux, France
Institut Bergonié
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
CH du Dr Duchenne
Boulogne-sur-Mer, France
CH de Bourg en Bresse
Bourg-en-Bresse, France
Centre François Baclesse
Caen, France
Institut d'Hématologie de Basse-Normandie
Caen, France
CH de Chalon sur Saône
Chalon-sur-Saône, France
CH de Chambéry
Chambéry, France
Hôpital Antoine Béclère
Clamart, France
CHU Estaing
Clermont-Ferrand, France
Hôpital Pasteur
Colmar, France
CH Sud Francilien de Corbeil
Corbeil-Essonnes, France
CHU Henri Mondor
Créteil, France
CHU de Dijon
Dijon, France
CH de Dunkerque
Dunkirk, France
CHU de Grenoble
Grenoble, France
CHD La Roche sur Yon
La Roche-sur-Yon, France
Centre Hospitalier de Versailles - André Mignot
Le Chesnay, 78157, France
Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, France
CH du Mans
Le Mans, France
Clinique Victor Hugo
Le Mans, France
CH de Lens
Lens, France
CHRU de Lille - Hôpital Claude Hurriez
Lille, 59037, France
CH de Saint Quentin
Lille, France
Hôpital Saint Vincent de Paul
Lille, France
CHU de Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
CH de Saint Germain
Mantes-la-Jolie, France
Chi Poissy /Saint- Germain-En-Laye
Mantes-la-Jolie, France
Institut Paoli Calmettes
Marseille, France
CH de Meaux
Meaux, France
CHR de Metz
Metz, France
Hôpital Saint Eloi
Montpellier, France
CHU de Mulhouse
Mulhouse, France
CHU Nancy Brabois
Nancy, France
CHU Hôtel Dieu Nantes
Nantes, France
Centre Antoine Lacassagne
Nice, France
CHU de Nice
Nice, France
CHU de Nîmes - Caremeau
Nîmes, France
Hôpital Necker
Paris, 75743, France
Hôpital de la Pitié Salpétrière
Paris, France
Hôpital Saint Antoine
Paris, France
Hôpital Saint Louis
Paris, France
Institut Curie
Paris, France
CH de Perpignan
Perpignan, France
Centre François Magendie
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Poitiers
Poitiers, France
CHU Robert Debré
Reims, France
CHU Pontchaillou
Rennes, France
CH de Roubaix
Roubaix, France
Centre Henri Becquerel
Rouen, France
Institut Curie - Centre René Huguenin
Saint-Cloud, France
CHU de Toulouse
Toulouse, France
CHU Bretonneau
Tours, 37044, France
CH Valence
Valence, France
CH de Valenciennes
Valenciennes, France
CH de Bretagne Atlantique
Vannes, France
Institut Gustave Roussy
Villejuif, France
Charité Medical School Campus Benjamin Franklin
Berlin, Germany
Charité Medical School Campus Virchow-Klinikum
Berlin, Germany
HELIOS Hospital Berlin-Buch
Berlin, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
Uniklinik Köln
Cologne, Germany
St Johannes-Hospital
Dortmund, Germany
Universitätsklinikum Carl Gustav Carus der TU Dresden
Dresden, Germany
Klinik Universitätsklinikum Düsseldorf
Düsseldorf, Germany
University of Duisburg-Essen
Essen, Germany
Krankenhaus Nordwest
Frankfurt am Main, Germany
Universitätklinikum Freiburg Klinik für Innere medizin I
Freiburg im Breisgau, Germany
UniversitätsKrebszentrum Göttingen - G-CCC
Göttingen, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Universitätsklinikum des Saarlandes
Homburg, Germany
Klinikum St. Georg gGmbH
Leipzig, Germany
Klinikum Oldenburg gGmbH
Oldenburg, Germany
Universitätsklinikum Ulm
Ulm, Germany
Istituto di Ematologia "Saragnoli" Policlinico San'Orsola-Malpighi, Bologna
Bologna, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
Ospedale Ferrarotto
Catania, Italy
Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo
Cuneo, Italy
Azienda Ospedaliera universitaria Careggi
Florence, Italy
Ematologia Oncologica Istituto Pascale
Napoli, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, Italy
Ematologia Università La Sapienza
Roma, Italy
AOU San Giovanni Battista
Torino, Italy
Clinica Ematologica di Udine
Udine, Italy
Instituto Português Oncologia
Lisbon, Portugal
National Cancer Centre Singapore
Singapore, Singapore
National University Cancer Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Dong-A Univ. Hospital
Busan, South Korea
National Cancer Center
Goyang-si, South Korea
Asian Medical Center
Seoul, South Korea
Korean Cancer Center Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital Yonsei University
Seoul, South Korea
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
ICO l'Hospitalet
Barcelona, Spain
ICO - Institut Català d'Oncologia - Hospital Doctor Josep Trueta
Girona, Spain
Hospital de Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
H. Morales Messeguer
Murcia, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
H. Virgen del Rocío
Seville, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Spain
Hospital Universitario Dr. Peset de Valencia
Valencia, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
Related Publications (2)
Camus V, Thieblemont C, Gaulard P, Cheminant M, Casasnovas RO, Ysebaert L, Damaj GL, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Gutierrez N, Penarrubia MJ, Staber PB, Trotman J, Huttmann A, Stefoni V, Tucci A, Fogarty P, Farhat H, Abraham J, Abarah W, Belmecheri F, Ribrag V, Delfau-Larue MH, Cottereau AS, Itti E, Li J, Delarue R, de Leval L, Morschhauser F, Bachy E. Romidepsin Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Final Analysis of the Ro-CHOP Trial. J Clin Oncol. 2024 May 10;42(14):1612-1618. doi: 10.1200/JCO.23.01687. Epub 2024 Feb 16.
PMID: 38364196DERIVEDBachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Garcia-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Huttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. doi: 10.1200/JCO.21.01815. Epub 2021 Nov 29.
PMID: 34843406DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Emmanuel BACHY, Professor
CH Lyon Sud, Pierre Bénite, France
- STUDY CHAIR
Vincent CAMUS, MD
Centre Henri Becquerel, Rouen, France
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 21, 2013
Study Start
January 1, 2013
Primary Completion
December 13, 2019
Study Completion
December 13, 2022
Last Updated
January 10, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share