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

January 9, 2023 updated by: The Lymphoma Academic Research Organisation

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
421

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • ZNA Stuivenberg
      • Brugge, Belgium
        • A.Z. Sint Jan AV
      • Bruxelles, Belgium
        • Institut Jules Bordet
      • Bruxelles, Belgium
        • UCL Louvain Saint Luc
      • Bruxelles, Belgium
        • ULB - Hôpital Erasme
      • Charleroi, Belgium
        • Grand Hôpital de Charleroi
      • Haine Saint Paul, Belgium
        • Hopital Jolimont
      • Jette, Belgium
        • AZ VUB
      • Kortrijk, Belgium
        • Az Groeninge
      • Liege, Belgium
        • CHU de Liege
      • Liege, Belgium
        • CHC - Clinique Saint Joseph
      • Yvoir, Belgium
        • Chu Mont Godinne
  • France
      • Amiens, France
        • CHU d'Amiens
      • Angers, France
        • CHU d'Angers
      • Annecy, France
        • CH de Annecy
      • Avignon, France
        • CH Henri Duffaut
      • Bayonne, France
        • CH Côte Basque
      • Besançon, France
        • Chu Jean Minjoz
      • Bordeaux, France
        • Institut Bergonie
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Bordeaux, France
        • CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie
      • Boulogne-sur-mer, France
        • CH du Dr Duchenne
      • Bourg en Bresse, France
        • CH de Bourg en Bresse
      • Béziers, France
        • CH de Béziers
      • Caen, France
        • Centre Francois Baclesse
      • Caen, France
        • Institut d'Hematologie de Basse-Normandie
      • Chalon sur Saône, France
        • CH de Chalon sur Saone
      • Chambéry, France
        • Ch De Chambery
      • Clamart, France
        • Hôpital Antoine Béclère
      • Clermont-Ferrand, France
        • CHU Estaing
      • Colmar, France
        • Hopital PASTEUR
      • Corbeil Essonnes, France
        • CH Sud Francilien de Corbeil
      • Créteil, France
        • CHU Henri Mondor
      • Dijon, France
        • CHU de DIJON
      • Dunkerque, France
        • CH de Dunkerque
      • Grenoble, France
        • CHU de Grenoble
      • La Roche sur Yon, France
        • CHD La Roche sur Yon
      • Le Chesnay, France, 78157
        • Centre Hospitalier de Versailles - André Mignot
      • Le Kremlin Bicêtre, France
        • Hôpital Kremlin Bicêtre
      • Le Mans, France
        • CH du Mans
      • Le Mans, France
        • Clinique Victor Hugo
      • Lens, France
        • CH de Lens
      • Lille, France, 59037
        • CHRU de Lille - Hôpital Claude Hurriez
      • Lille, France
        • Hopital Saint Vincent de Paul
      • Lille, France
        • CH de Saint Quentin
      • Limoges, France
        • CHU de Limoges
      • Lyon, France
        • Centre Léon Bérard
      • Mantes-La-Jolie, France
        • CH de Saint Germain
      • Mantes-la-Jolie, France
        • Chi Poissy /Saint- Germain-En-Laye
      • Marseille, France
        • Institut Paoli Calmettes
      • Meaux, France
        • CH de Meaux
      • Metz, France
        • CHR de Metz
      • Montpellier, France
        • Hopital Saint Eloi
      • Mulhouse, France
        • CHU de Mulhouse
      • Nancy, France
        • CHU Nancy Brabois
      • Nantes, France
        • CHU Hotel Dieu Nantes
      • Nice, France
        • Centre Antoine Lacassagne
      • Nice, France
        • Chu de Nice
      • Nimes, France
        • CHU de Nimes - Caremeau
      • Paris, France, 75743
        • Hôpital Necker
      • Paris, France
        • Hopital de la Pitie Salpetriere
      • Paris, France
        • Hopital Saint Antoine
      • Paris, France
        • Hopital Saint Louis
      • Paris, France
        • Institut Curie
      • Perpignan, France
        • CH de Perpignan
      • Pessac, France
        • Centre Francois Magendie
      • Pierre Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France
        • CHU De Poitiers
      • Reims, France
        • CHU Robert Debré
      • Rennes, France
        • Chu Pontchaillou
      • Roubaix, France
        • CH de Roubaix
      • Rouen, France
        • Centre Henri Becquerel
      • Saint Cloud, France
        • Institut Curie - Centre Rene Huguenin
      • Toulouse, France
        • CHU de Toulouse
      • Tours, France, 37044
        • Chu Bretonneau
      • Valence, France
        • CH Valence
      • Valenciennes, France
        • Ch de Valenciennes
      • Vannes, France
        • Ch de Bretagne Atlantique
      • Villejuif, France
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany
        • Vivantes Klinikum Neukölln
      • Berlin, Germany
        • Charité Medical School Campus Benjamin Franklin
      • Berlin, Germany
        • Charité Medical School Campus Virchow-Klinikum
      • Berlin, Germany
        • Helios Hospital Berlin-Buch
      • Dortmund, Germany
        • St Johannes-Hospital
      • Dresden, Germany
        • Universitätsklinikum Carl Gustav Carus der TU Dresden
      • Düsseldorf, Germany
        • Klinik Universitätsklinikum Düsseldorf
      • Essen, Germany
        • University of Duisburg-Essen
      • Frankfurt am Main, Germany
        • Krankenhaus Nordwest
      • Freiburg, Germany
        • Universitätklinikum Freiburg Klinik für Innere medizin I
      • Greifswald, Germany
        • Universitätsmedizin Greifswald
      • Göttingen, Germany
        • UniversitätsKrebszentrum Göttingen - G-CCC
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Homburg, Germany
        • Universitätsklinikum des Saarlandes
      • Köln, Germany
        • Uniklinik Koln
      • Leipzig, Germany
        • Klinikum St. Georg gGmbH
      • Oldenburg, Germany
        • Klinikum Oldenburg gGmbH
      • Ulm, Germany
        • Universitatsklinikum Ulm
  • Italy
      • Bologna, Italy
        • Istituto di Ematologia "Saragnoli" Policlinico San'Orsola-Malpighi, Bologna
      • Brescia, Italy
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Catania, Italy
        • Ospedale Ferrarotto
      • Cuneo, Italy
        • Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo
      • Firenze, Italy
        • Azienda Ospedaliera Universitaria Careggi
      • Napoli, Italy
        • Ematologia Oncologica Istituto Pascale
      • Reggio Calabria, Italy
        • Azienda Ospedaliera Bianchi Melacrino Morelli
      • Roma, Italy
        • Ematologia Università La Sapienza
      • Torino, Italy
        • AOU San Giovanni Battista
      • Udine, Italy
        • Clinica Ematologica di Udine
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Dong-A Univ. Hospital
      • Goyang-si, Korea, Republic of
        • National Cancer Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Asian Medical Center
      • Seoul, Korea, Republic of
        • Korean Cancer Center Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital Yonsei University
  • Portugal
      • Lisbon, Portugal
        • Instituto Português Oncologia
  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
      • Singapore, Singapore
        • National Cancer Centre Singapore
      • Singapore, Singapore
        • National University Cancer Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • ICO L'Hospitalet
      • Barcelone, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Girona, Spain
        • ICO - Institut Català d'Oncologia - Hospital Doctor Josep Trueta
      • Jerez de la Frontera, Spain
        • Hospital de Jerez de la Frontera
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Murcia, Spain
        • H. Morales Messeguer
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Salamanca, Spain
        • Hospital Clínico Universitario de Salamanca
      • Sevilla, Spain
        • H. Virgen del Rocío
      • Valencia, Spain
        • Hospital Arnau de Vilanova de Valencia
      • Valencia, Spain
        • Hospital Universitario Dr. Peset de Valencia
      • Valladolid, Spain
        • Hospital Clinico Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females of 18 years of age to 80 years of age.
  2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
  3. Able to adhere to the study visit schedule and other protocol requirements.

  4. 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

  5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  6. Negative pregnancy test for Females of ChildBearing Potential (FCBP)
  7. 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.
  8. Life expectancy of ≥ 90 days (3 months).

Exclusion Criteria:

  1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
  2. Any condition that confounds the ability to interpret data from the study.
  3. Other types of lymphomas, e.g. B-cell lymphoma

  4. The following types of T cell lymphomas:

    1. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
    2. Extranodal T-cell/Natural Killer (NK)-cell lymphoma, nasal type
    3. Anaplastic large cell lymphoma, ALK-positive type
    4. Cutaneous T cell lymphoma (mycosis fungoid, Sézary syndrome)
    5. Primary cutaneous cluster of differentiation antigen 30 positive (CD30+) T-cell lymphoproliferative disorder
    6. Primary cutaneous anaplastic T-cell lymphoma
  5. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
  6. Previous radiotherapy for PTCL except if localized to one lymph node area
  7. Patients planned for autologous or allogeneic transplant as consolidation in first line
  8. Central nervous system -meningeal involvement
  9. Contraindication to any drug contained in the chemotherapy regimen,
  10. Subjects with HIV positivity
  11. 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.

  12. Any of the following laboratory abnormalities, except if secondary to the lymphoma:

    1. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
    2. Platelet count < 100,000/mm3 (100 x 109/L), or < 75,000/mm3 if bone marrow is involved,
    3. Serum Aspartate Aminotransferase (ASAT/AST) or Alanine Aminotransferase (ALAT/ALT) ≥ 3.0 x Upper Limit of Normal (ULN),
    4. Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
    5. K+ and Mg2+ levels < Lower Limit of Normal (LLN), except if corrected per protocol guidance before beginning the romidepsin infusion
  13. Serum creatinine > 2.0 x ULN
  14. 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
  15. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form

  16. Any known cardiac abnormalities such as:

    1. Patients with congenital long QT syndrome
    2. Corrected QT interval > 480 msec (using the Fridericia formula)
    3. Myocardial infarction within 6 months of cycle 1 day 1
    4. History of or concomitant significant cardiovascular disease
    5. Ejection fraction <45% by multigated acquisition (MUGA) scan or by echocardiogram;
  17. Concomitant use of drugs that may cause a significant prolongation of the corrected QT interval (QTc)
  18. Patients who have received more than 200 mg/m2 doxorubicin
  19. Concomitant use of strong CYP3A4 inhibitors
  20. 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.
  21. Clinically significant active infection
  22. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug
  23. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Romidepsin plus CHOP

Patients 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.
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.
Active Comparator: Standard: CHOP
Patients in control Arm receive cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
Drug: CHOP
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary efficacy endpoint is Progression Free Survival
Time Frame: 60 months
The primary efficacy endpoint is Progression Free Survival (PFS) using the response criteria for malignant lymphoma (1999) by a Response Adjudication Committee
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Lymphoma Academic Research Organisation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Emmanuel BACHY, Professor, CH Lyon Sud, Pierre Bénite, France
  • Study Chair: Vincent CAMUS, MD, Centre Henri Becquerel, Rouen, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ro-CHOP Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral T-cell Lymphoma

Clinical Trials on Romidepsin + CHOP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings