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    Summary
    EudraCT Number:2012-001580-68
    Sponsor's Protocol Code Number:Ro-CHOP_study
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-001580-68
    A.3Full title of the trial
    Phase 3 Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin¬ CHOP (Ro-CHOP) versus CHOP in subjects with Previously Untreated Peripheral T-Cell Lymphoma.
    Etude de phase III multicentrique randomisée pour comparer l’efficacité et la tolerance de l’association romidepsine CHOP (Ro-CHOP) versus CHOP chez des patients atteints d’un lymphome T périphérique non préalablement traité.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin¬ CHOP (Ro-CHOP) versus CHOP in subjects with Previously Untreated Peripheral T-Cell Lymphoma.
    Etude multicentrique randomisée pour comparer l’efficacité et la tolerance de l’association romidepsine CHOP (Ro-CHOP) versus CHOP chez des patients atteints d’un lymphome T périphérique non préalablement traité.
    A.3.2Name or abbreviated title of the trial where available
    Ro-CHOP_study
    A.4.1Sponsor's protocol code numberRo-CHOP_study
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLYSARC
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointAnne Viola
    B.5.3 Address:
    B.5.3.1Street AddressLYSARC - CH Lyon Sud - Bâtiment 2D
    B.5.3.2Town/ cityPierre Bénite Cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number33472 66 93 33
    B.5.5Fax number33426 07 40 13
    B.5.6E-mailaffaires-reglementaires@lysarc.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Istodax
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/328
    D.3 Description of the IMP
    D.3.1Product nameromidepsin
    D.3.2Product code FK228
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROMIDEPSIN
    D.3.9.1CAS number 128517-07-7
    D.3.9.4EV Substance CodeSUB26362
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Peripheral T-Cell Lymphoma
    Lymphome T périphérique
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    Lymphome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10034623
    E.1.2Term Peripheral T-cell lymphoma unspecified
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL)
    L’objectif principal de l’étude est de comparer l’efficacité de la romidepsine associée au CHOP versus CHOP seule chez des sujets atteints d’un lymphome T périphérique (PTCL) non préalablement traité
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare Ro-CHOP and CHOP alone in terms of:
    • Overall survival
    • Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999)
    • Duration of response
    • Time to progression
    • Time to treatment failure
    • Safety
    • Quality of Life (QoL)
    • Response rates by PTCL histological subtypes
    • Response rate by standard prognostic parameters
    Les objectifs secondaires sont pour comparer Ro-CHOP et CHOP seul en termes de:
    • Survie globale
    • Taux de réponse global (ORR [PR+CR+CRu]) (selon les critères de réponse pour les lymphomes de Cheson 1999)
    • Durée de la réponse
    • Temps jusqu’à progression
    • Temps jusqu’à échec du traitement
    • Tolérance
    • Qualité de vie (QoL)
    • Taux de réponse par sous-types histologiques de PTCL
    • Taux de réponse par paramètres pronostiques standard
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must satisfy all following criteria to be enrolled in the study:
    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 WHO classification (2008;2011) may be included, whatever the Ann Arbor stage (l-lV):
    a. Nodal types:
    i. PTCL, not otherwise specified
    ii. Angioimmunoblastic T-cell lymphoma
    iii. Anaplastic large cell lymphoma, 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 CD8+ aggresive epidermotropic lymphoma
    vi. Primary cutaneous CD4+ small/medium T-cell lymphoma
    c. Other non classifiable peripheral T-cell lymphoma
    5. 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).
    Les patients doivent satisfaire les critères suivants pour être inclus dans l’étude:
    1. Hommes ou femmes entre 18 et 80 ans.
    2. Avoir compris et signé un consentement éclairé avant que toute procédure ou évaluations reliées à l’étude ne soit conduite.
    3. Etre capable d’adhérer au schéma de visites prévues dans le protocole et autre exigence du protocole.
    4. Patients atteints d’un lymphome T périphérique histologiquement prouvé non préalablement traité. Les sous-types suivants définis par la classification OMS (2008;2011) peuvent être inclus, quelque soit le stade Ann Arbor (l-lV):
    a. Types « ganglionnaire »:
    i. PTCL
    ii. Lymphome T angioimmunoblastique
    iii. Lymphome anaplasique à grandes cellules, ALK-négatif

    b. Types « extranodaux »:
    i. Lymphome T associé à une entéropathie
    ii. Lymphome T hépatosplénique
    iii. Lymphome T type panniculite sous-cutanée
    iv. Lymphome T cutané gamma-delta
    v. Lymphome cutané épidermotropique agressif à cellules T CD8+
    vi. Lymphome cutané à petites/moyennes cellules T CD4+
    c. Autre lymphome T périphérique non classifiable
    5. ECOG performance status 0, 1 ou 2.
    6. Test de grossesse négatif pour les femmes en âge de procréer.
    7. Les femmes en âge de procréer doivent utiliser une méthode efficace de contraception (contraception hormonale, stérilet, diaphragme avec spermicide, préservatif avec spermicide ou abstinence) pendant la durée du traitement et 1 mois après; les hommes doivent utiliser une méthode de contraception pendant la durée du traitement et 3 mois après.
    8. Espérance de vie ≥ 90 jours (3 mois).
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a patient from enrollment:
    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:
    a. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
    b. Extranodal T-cell/NK-cell lymphoma, nasal type
    c. Anaplastic large cell lymphoma, ALK-positive type
    d. Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome)
    e. Primary cutaneous CD30+ T-cell lymphoproliferative disorder
    f. 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 without HBV DNA positive blood are eligible after advice from hepatologist and initiation of prophylactic treatment if needed. Subjects with non-active hepatitis C (with normal transaminases) are eligible. Patients with HBc Ab+/ HBs Ab+/ HBs Ag- and HBV DNA- should be referred to an hepatologist and a prophylactic treatment should be initiated if needed
    12. Any of the following laboratory abnormalities, except if secondary to the lymphoma:
    a. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
    b. Platelet count < 100,000/mm3 (100 x 109/L), or < 75,000/mm3 if bone marrow is involved,
    c. Serum SGOT/AST or SGPT/ALT ≥ 3.0 x upper limit of normal (ULN),
    d. Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
    e. K+ and Mg2+ levels < 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:
    a. Patients with congenital long QT syndrome,
    b. Corrected QT interval > 480 msec (using the Fridericia formula),
    c. Myocardial infarction within 6 months of cycle 1 day 1,
    d. History of or concomitant significant cardiovascular disease,
    e. Ejection fraction <45% by MUGA scan or by echocardiogram.
    17. Concomitant use of drugs that may cause a significant prolongation of the QTc.
    18. Patients who have received more than 200 mg/m2 doxorubicin.
    19. Concomitant use of strong CYP3A4 inhibitors (see Appendix)
    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.
    1. Toute condition médicale significative, anomalie biologique, ou maladie psychiatrique qui empêcherait la participation du patient à l’étude.
    2. Toute condition qui empêcherait l’interprétation des données de l’étude.
    3. Tout autre type de lymphome, comme le lymphome B.
    4. Les types de lymphome T suivants:
    a. Lymphome/leucémie T de l’adulte (Lymphome T lié au HTLV-1)
    b. Lymphome extranodal T/NK, type nasal
    c. Lymphome anaplasique à grandes cellules, ALK-positive
    d. Lymphome T cutané (mycosis fongoïdes, syndrome de Sézary)
    e. Papulose lymphomatoïde et autres proliférations cutanées à cellules T CD30+
    f. Lymphome T cutané anaplasique
    5. Antécédents de traitement du PTCL par immunothérapie ou chimiothérapie excepté un traitement par corticostéroïdes de court terme (durée <= à 8 jours) avant randomisation
    6. Antécédents de radiothérapie pour le PTCL excepté si localisée à une aire ganglionnaire
    7. Les patients prévus pour une transplantation autologue ou allogénique comme consolidation en première ligne
    8. Envahissement méningé ou du SNC
    9. Contre indication à toute molécule de la chimiothérapie.
    10. Sujet HIV positif
    11. Sujets avec une hépatite B ou C active. Les porteurs chroniques d’hépatite B sans ADN viral dans le sang sont éligibles après consultation par l'hépatologue et induction d'un traitement prophylactique si nécessaire. Les sujets avec une hépatite C non active (avec transaminases normales) sont éligibles. Les patients avec sérologie HBc Ab+/ HBs Ab+/ HBs Ag- et non porteurs d'ADN viral de l'hépatite B devraient être orientés vers un hépatologue et un traitement prophylactique devrait être initié si nécessaire.
    12. Toute anomalie biologique suivante, excepté si secondaire au lymphome :
    a. Nombre absolu de neutrophiles (ANC) < 1,500 cellules/mm3 (1.5 x 109/L),
    b. Nombre de plaquettes < 100,000/mm3 (100 x 109/L), ou < 75,000/mm3 si la moelle osseuse est envahie,
    c. SGOT/AST ou SGPT/ALT sérique ≥ 3.0 x limite supérieure de la normale (ULN),
    d. Bilirubine totale sérique > 2 x ULN, excepté en cas d’anémie hémolytique,
    e. Niveau de K+ et Mg2+ < LLN, excepté si corrigé selon le protocole avant le début de la perfusion de romidepsin
    13. Créatinine sérique > 2.0 x ULN
    14. Antécédent de cancer autre que le lymphome (excepté carcinome basocellulaire ou cutané de la peau ou carcinome in situ du col ou du sein ou cancer de la prostate non traité sans prévision de traitement) sauf si le patient est dépourvu de la maladie depuis 3 ans
    15. Toute condition médicale sérieuse, anomalie biologique ou maladie psychiatrique qui empêcherait le patient de signer son consentement de façon éclairée
    16. Toute anomalie cardiaque connue comme:
    a. les patients avec un syndrome du QT long congénital
    b. Intervalle QT corrigé > 480 msec (d’après la formule de Fridericia)
    c. Infarctus du myocarde dans les 6 mois avant le 1er jour du 1er cycle
    d. Antécédent de ou maladie cardiovasculaire significative concomitante
    e. Fraction d’éjection <45% par scan MUGA ou par échocardiogramme;
    17. Utilisation concomitante de molécules susceptibles de provoquer un allongement significatif du QTc
    18. Patients ayant reçu plus de 200 mg/m2 de doxorubicine
    19. Utilisation concomitante d’inhibiteurs forts du CYP3A4
    20. Utilisation concomitante de warfarine à dose thérapeutique du fait d’une potentielle interaction. L’utilisation de faible dose de warfarine ou autre anticoagulant pour maintenir la perméabilité de l’accès au port veineux et canules est permise.
    21. Infection active cliniquement significative
    22. Utilisation de toute thérapie anti cancéreuse standard ou expérimentale dans les 28 jours précédant l’initiation du traitement (Jour 1)
    23. Femmes enceintes ou allaitantes ou femmes en âge de procréer non prêtes à utiliser une méthode adéquate de contraception pour la durée de l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) assessed according to progression criteria for malignant lymphoma 1999 by a Response adjudication committee.
    Survie sans progression, évaluée selon les critères de progression pour les lymphomes (1999) par une revue centralisée de l'imagerie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessment (clinical examination, laboratory tests, pelvis, abdominal, chest and cervical CT scan, bone marrow examination) will be performed at baseline, at mid-treatment after 3 cycles (CT scan only) and 4 weeks after the last treatment dose. To ensure comparability, baseline and on-study methods for response assessment will be performed using identical techniques.
    Follow-up assessment, including CT Scan, will be clinical visit every 3 months the first year, then every 4 months the 2nd year, and every 6 months thereafter.
    L’évaluation de la tumeur (examen clinique, tests de laboratoire, CT scan (cervical, pelvien, abdominal et thoracique), biopsie de moelle osseuse) sera réalisée en baseline, en milieu de traitement après 3 cycles (seulement par un CT scan) et 4 semaines après la dernière dose administrée. Pour assurer la comparabilité, l’évaluation de la réponse à la baseline et en fin de traitement devra être réalisée avec les mêmes techniques.
    Une visite clinique pour l’évaluation du suivi sera faite tous les 3 mois pendant la première année, tous les 4 mois pendant la deuxième année et tous les 6 mois par la suite pendant au moins 6 ans.
    E.5.2Secondary end point(s)
    • Overall survival
    • Overall Response Rate (ORR [PR+CR+CRu]) (according to the Response criteria for malignant lymphoma 1999)
    • Duration of response
    • Time to progression
    • Time to treatment failure
    • Safety
    • Quality of Life (QoL)
    • Response rates by PTCL histological subtypes
    • Response rate by standard prognostic parameters
    • Survie globale
    • Taux de réponse global (ORR [PR+CR+CRu]) (selon les critères de réponse pour les lymphomes de Cheson 1999)
    • Durée de la réponse
    • Temps jusqu’à progression
    • Temps jusqu’à échec du traitement
    • Tolérance
    • Qualité de vie (QoL)
    • Taux de réponse par sous-types histologiques de PTCL
    • Taux de réponse par paramètres pronostiques standard
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Overall survival: 2 years after the end of treatment
    • Overall Response Rate (ORR [PR+CR+CRu]): at the end of treatment
    • Duration of response: all duration of the study
    • Time to progression: all duration of the study
    • Time to treatment failure: all duration of the study
    • Safety: all duration of the study
    • Quality of Life (QoL) :At randomization, at D1 of cycle 4, at evaluation at the end of treatment, and during follow-up every 3 months the first year, every 4 months the second year and every year during follow-up period until primary analysis
    • Response rates by PTCL histological subtypes:at the end of treatment
    • Response rate by standard prognostic parameters: at the end of treatment
    • Survie globale: 2 ans après la fin de traitement
    • Taux de réponse global (ORR [PR+CR+CRu]): en fin de traitement
    • Durée de la réponse: tout au long de l'étude
    • Temps jusqu’à progression: tout au long de l'étude
    • Temps jusqu’à échec du traitement: tout au long de l'étude
    • Tolérance: tout au long de l'étude
    • Qualité de vie (QoL): en baseline, au J1 du C4, en fin de traitement, et pendant le suivi tous les trois mois pendant la première année, tous les quatre mois pendant la deuxième année, puis tous les ans par la suite jusqu'à l'analyse principale
    • Taux de réponse par sous-types histologiques de PTCL: en fin de traitement
    • Taux de réponse par paramètres pronostiques standard: en fin de traitement
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    association of romidepsin and CHOP versus CHOP alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    France
    Germany
    Italy
    Korea, Democratic People's Republic of
    Portugal
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be the end of follow up so approximately 5 years after the last patient randomized.
    La fin de l'essai sera à la fin du suivi protocolaire soit approximativement 5 ans après le dernier patient randomisé.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 420
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    no difference
    pas de différence
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-13
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