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Peripheral T-cell LymphomaPhase 3NCT01796002

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

A Phase 3 study testing Romidepsin + CHOP and CHOP in people with Peripheral T-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 131 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Peripheral T-cell Lymphoma
What is being tested?
Romidepsin + CHOP and CHOP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
421 participants
Where
131 sitesin 8 countries
Study dates
Jan 2013to 13 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
  • Nodal types: i. PTCL, not otherwise specified ii. Angioimmunoblastic T-cell lymphoma iii. Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK)-negative type
  • 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
Show all 11Show fewer
  • 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).

Who cannot join

  • 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
Show all 39Show fewer
  • 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,
  • Subjects with HIV positivity
  • Subjects with active hepatitis B or C. Chronic carriers of Hepatitis B virus (HBV) without HBV DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible.
  • Any of the following laboratory abnormalities, except if secondary to the lymphoma:
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
  • Platelet count < 100,000/mm3 (100 x 109/L), or < 75,000/mm3 if bone marrow is involved,
  • Serum Aspartate Aminotransferase (ASAT/AST) or Alanine Aminotransferase (ALAT/ALT) ≥ 3.0 x Upper Limit of Normal (ULN),
  • Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
  • K+ and Mg2+ levels < Lower Limit of Normal (LLN), except if corrected per protocol guidance before beginning the romidepsin infusion
  • Serum creatinine > 2.0 x ULN
  • Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
  • Any known cardiac abnormalities such as:
  • Patients with congenital long QT syndrome
  • Corrected QT interval > 480 msec (using the Fridericia formula)
  • Myocardial infarction within 6 months of cycle 1 day 1
  • History of or concomitant significant cardiovascular disease
  • Ejection fraction <45% by multigated acquisition (MUGA) scan or by echocardiogram;
  • Concomitant use of drugs that may cause a significant prolongation of the corrected QT interval (QTc)
  • Patients who have received more than 200 mg/m2 doxorubicin
  • Concomitant use of strong CYP3A4 inhibitors
  • Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
  • Clinically significant active infection
  • Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug
  • Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.

Trial locations and contacts

131 sites in 8 countries.

131 sites in 8 countries

France67 sites

  • 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

  • Centre Hospitalier de Versailles - André Mignot

    Le Chesnay, 78157

  • Hôpital Kremlin Bicêtre

    Le Kremlin-Bicêtre

  • CH du Mans

    Le Mans

  • Clinique Victor Hugo

    Le Mans

  • CH de Lens

    Lens

  • CHRU de Lille - Hôpital Claude Hurriez

    Lille, 59037

  • 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 Necker

    Paris, 75743

  • 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

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • 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

  • CHU Bretonneau

    Tours, 37044

  • CH Valence

    Valence

  • CH de Valenciennes

    Valenciennes

  • CH de Bretagne Atlantique

    Vannes

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Germany18 sites

  • 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

Other trials in Germany

Spain14 sites

  • 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

Other trials in Spain

Belgium12 sites

  • 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

Other trials in Belgium

Italy10 sites

  • 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

    Naples

  • Azienda Ospedaliera Bianchi Melacrino Morelli

    Reggio Calabria

  • Ematologia Università La Sapienza

    Roma

  • AOU San Giovanni Battista

    Torino

  • Clinica Ematologica di Udine

    Udine

Other trials in Italy

South Korea6 sites

  • 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

Other trials in South Korea

Singapore3 sites

  • National Cancer Centre Singapore

    Singapore

  • National University Cancer Hospital

    Singapore

  • Singapore General Hospital

    Singapore

Other trials in Singapore

Portugal1 site

  • Instituto Português Oncologia

    Lisbon

Other trials in Portugal

About this study

Official title: 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

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).

Read the detailed description

This is a randomized multi-center phase III study, to compare efficacy and safety of Ro-CHOP with standard CHOP regimen in patients with previously untreated, histologically proven PTCL. Given the nature of the experimental agent, this study is an open-label study. Patients are randomized 1:1 to receive either (Arm A) cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles [22] or (Arm B) romidepsin CHOP (Ro-CHOP) administered in 3 week cycles for 6 cycles. In the Ro-CHOP arm, romidepsin will be administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks. In this study, patients will advance through three phases of the study: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary withdrawal. Patients will be followed for survival until the earliest of either 80% of patients have died or 3 years from the last patient randomized. Three years after the primary analysis an update of the database will be done and a rerun of the analysis will be performed.

Being tested
Romidepsin + CHOP, CHOP
Keywords
PTCL
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Romidepsin + CHOPDrug

    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.

  • CHOPDrug

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

Study groups in NCT01796002
Study groupRoleWhat they receive
Experimental: Romidepsin plus CHOPExperimentalPatients 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.
Receives: Drug: Romidepsin + CHOP
Standard: CHOPActive comparatorPatients in control Arm receive cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
Receives: Drug: CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completion13 Dec 2019
  4. Study completion13 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01796002
Sponsor's protocol ID
Ro-CHOP Study
Status last verified
Jan 2023
First submitted
31 Jan 2013
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38364196

  • Bachy 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.

    PubMed 34843406

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Romidepsin + CHOP and CHOP in people with Peripheral T-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 131 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in France, Germany, Spain, Belgium, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy endpoint is Progression Free Survival (time frame: 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01796002, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.

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