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    Summary
    EudraCT Number:2012-001580-68
    Sponsor's Protocol Code Number:Ro-CHOP
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-30
    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 ConcernedAustria - BASG
    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 patients with previously untreated peripheral T-cell lymphoma.
    Randomisierte Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit von Romidepsin in Verbindung mit CHOP-Chemotherapie (Ro-CHOP) gegenüber CHOP allein bei Patienten mit zuvor unbehandeltem peripheren T-Zell-Lymphom.
    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 patients with previously untreated peripheral T-cell lymphoma.
    Randomisierte Studie zum Vergleich der Wirksamkeit und Sicherheit von Romidepsin in Verbindung mit CHOP-Chemotherapie (Ro-CHOP) gegenüber CHOP allein bei Patienten mit zuvor unbehandeltem peripheren T-Zell-Lymphom.
    A.3.2Name or abbreviated title of the trial where available
    Ro-CHOP
    A.4.1Sponsor's protocol code numberRo-CHOP
    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 pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressLYSARC - CH Lyon Sud - Batiment 2D
    B.5.3.2Town/ cityPierre-Bénite Cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+330472 66 93 33
    B.5.5Fax number+330426 07 40 55
    B.5.6E-mailro-chop-study@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.3.9.3Other descriptive nameIstodax
    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.
    Peripheres T-Zell-Lyphom.
    E.1.1.1Medical condition in easily understood language
    Lymphoma.
    Lymphom.
    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).
    Das primäre Ziel der Studie ist es, die Wirksamkeit der Verabreichung von Romidepsin zusammen mit CHOP im Vergleich zur alleinigen Gabe von CHOP bei Patienten mit zuvor unbehandelten peripheren T-Zell-Lymphom (PTCL) zu vergleichen.
    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
    Die sekundären Ziele sind der Vergleich von Ro-CHOP CHOP allein in Bezug auf:
    • Gesamtüberleben
    • Gesamtansprechrate (ORR [PR + CR + CRu]) (gemäß den Ansprechkriterien für maligne Lymphome 1999)
    • Dauer des Ansprechens
    • Zeit bis zur Progression
    • Zeit bis zum Therapieversagen
    • Sicherheit
    • Lebensqualität (QoL)
    • Ansprechraten nach histologischen PTCL-Subtypen
    • Ansprechrate nach prognostischen Standardparametern
    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).
    Die Patienten müssen alle folgenden Kriterien erfüllen, um an der Studie teilnehmen zu können:
    1. Männer und Frauen zwischen 18 und 80 Jahren.
    2. Verstehen und freiwilliges Unterzeichnen einer Einverständniserklärung, bevor studienbezogene Untersuchungen/Verfahren durchgeführt werden.
    3. Fähigkeit, sich an den Behandlungsplan und andere Protokollanforderungen halten zu können.
    4. Patienten mit histologisch nachgewiesenem peripheren T-Zell-Lymphom (PTCL), das zuvor nicht behandelt wurde; die folgenden Subtypen gemäß WHO-Klassifizierung (2008; 2011) können unabhängig vom Ann-Arbor-Stadium (I-IV) aufgenommen werden:
    a. Nodale Typen:
    i. PTCL, nicht anderweitig spezifiziert
    ii. Angioimmunoblastisches T-Zell-Lymphom
    iii. Anaplastisches großzelliges Lymphom, ALK-negativ
    b. Extranodale Typen:
    i. Enteropathie-assoziiertes T-Zell-Lymphom
    ii. Hepatosplenisches T-Zell-Lymphom
    iii. Subkutanes, Panniculitis-ähnliches T-Zell-Lymphom
    iv. Primäres kutanes Gamma-Delta-T-Zell-Lymphom
    v. Primäres kutanes CD8-positives aggressives epidermotropisches Lymphom
    vi. Primäres kutanes CD4-positives kleines/mittelgroßes T-Zell-Lymphom
    c. Sonstiges, nicht klassifizierbares peripheres T-Zell-Lymphom
    5. ECOG-Leistungsstatus 0, 1 oder 2
    6. Negativer Schwangerschaftstest für Frauen im gebärfähigen Alter
    7. Patientinnen im gebärfähigen Alter müssen eine zuverlässige Verhütungsmethode (d. h. hormonelles Verhütungsmittel, Spirale, Diaphragma mit Spermizid, Kondom mit Spermizid oder Enthaltsamkeit) während der Behandlungsphase und 1 Monat danach anwenden; männliche Patienten müssen eine zuverlässige Verhütungsmethode während der Behandlungsphase und 3 Monate danach anwenden.
    8. Lebenserwartung von ≥ 90 Tagen (3 Monaten).
    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.
    Das Vorhandensein eines der folgenden Kriterien führt zum Ausschluss eines Patienten:
    1. Jede signifikante Erkrankung, Laboranomalie oder psychiatrische Krankheit, die die Teilnahme des Patienten an der Studie behindern würde.
    2. Alle Bedingungen, die die Fähigkeit, Daten aus der Studie zu interpretieren, beeinflussen würde.
    3. Andere Arten von Lymphomen, z. B. B-Zell-Lymphom.
    4. Die folgenden Arten von T-Zell-Lymphomen:
    a. Adultes T-Zell-Lymphom/Leukämie (HTLV-1-bezogenes T-Zell-Lymphom)
    b. Extranodales T-Zell-/NK-Zell-Lymphom, nasal
    c. Anaplastisches großzelliges Lymphom, ALK-positiv
    d. Kutanes T-Zell-Lymphom (Mycosis fungoides, Sézary-Syndrom)
    e. Primäre kutane CD30-positive T-Zell-lymphoproliferative Störung
    f. Primäres kutanes anaplastisches T-Zell-Lymphom
    5. Vorherige Behandlung für PTCL mit Immuntherapie oder Chemotherapie außer kurzfristigen Kortikosteroiden (Dauer von ≤ 8 Tagen) vor der Randomisierung
    6. Vorherige Strahlentherapie für PTCL, außer wenn dieses sich in einem Lymphknotenbereich befindet
    7. Patienten, die für eine autologe oder allogene Transplantation als Erstlinien-Konsolidierung vorgesehen sind
    8. Beteiligung der Meningen des zentralen Nervensystems,
    9. Gegenanzeige gegenüber einem im Chemotherapieplan enthaltenen Wirkstoff
    10. HIV-positive Probanden
    11. Patienten mit aktiver Hepatitis B oder C, chronische Träger einer Hepatitis B ohne HBV DNA-positivem Blut können teilnehmen, nach Beratung durch einen Hepatologen und Initiierung von prophylaktischen Behandlung, wenn nötig. Patienten mit nicht-aktiven Hepatitis C (mit normalen Transaminasen) können teilnehmen. Patienten mit HBc Ab + / HBs Ab + / HBs-Ag- und HBV DNA sollte einem Hepatologen vorgestellt werden und eine prophylaktische Behandlung sollte, wenn nötig eingeleitet werden.
    12. Jede der folgenden Laboranomalien, außer wenn diese mit dem Lymphom in Verbindung stehen:
    a. Absolute Neutrophilenzahl (ANC) < 1.500 Zellen/mm³ (1,5 x 109/L)
    b. Thrombozytenzahl < 100.000/mm³ (100 x 109/L) oder < 75.000/mm³, wenn das Knochenmark betroffen ist
    c. Serum SGOT/AST oder SGPT/ALT ≥ 3,0 x obere Normgrenze (ULN)
    d. Serum-Gesamtbilirubin > 2-Fache des ULN, außer im Fall einer hämolytischen Anämie
    e. K+- und Mg²+-Werte < LLN, es sei denn, diese wurden gemäß Protokollrichtlinie vor Beginn der Romidepsin-Infusion korrigiert
    13. Serumkreatinin > 2,0 x ULN
    14. Vorgeschichte von Malignitäten außer einem Lymphom (mit Ausnahme des Basalzell- oder Plattenepithelkarzinoms der Haut oder des In-situ-Karzinoms der Zervix oder Brust oder unbehandelter Prostatakrebs ohne Behandlungsplan, sofern der Patient ≥ 3 Jahre krankheitsfrei ist
    15. Jede schwere Erkrankung, Laboranomalie oder psychiatrische Krankheit, die den Patienten an der Unterzeichnung der Einverständniserklärung hindern würde
    16. Alle bekannten Herzanomalien, wie zum Beispiel:
    a. Patienten mit angeborenem langem QT-Syndrom
    b. Korrigiertes QT-Intervall > 480 msec (mithilfe der Fridericia-Formel)
    c. Myokardinfarkt innerhalb von 6 Monaten vor Zyklus 1, Tag 1
    d. Vorgeschichte begleitender signifikanter Herz-Kreislauf-Erkrankungen
    e. Ejektionsfraktion < 45 % anhand Radionuklidventrikulographie oder Echokardiogramm;
    17. Gleichzeitige Einnahme von Arzneimitteln, die zu einer signifikanten Verlängerung von QTc führen kann
    18. Patienten, die mehr als 200 mg/m² Doxorubicin erhalten
    19. Gleichzeitige Einnahme von starken CYP3A4-Hemmern
    20. Gleichzeitige Einnahme von therapeutischem Warfarin aufgrund einer möglichen Wirkstoffwechselwirkung. Die Einnahme einer geringen Dosis Warfarin oder eines anderen Antikoagulans, um die Durchgängigkeit eines Venenzugangsports und von Kanülen aufrechtzuerhalten, ist zugelassen.
    21. Klinisch signifikante aktive Infektion
    22. Einnahme eines standardmäßigen oder experimentellen Anti-Krebs-Medikaments innerhalb von 28 Tagen nach Beginn (Tag 1) der Einnahme des Prüfpräparats
    23. Schwangere oder stillende Frauen oder Frauen im gebärfähigen Alter, die nicht bereit sind, eine zuverlässige Verhütungsmethode während der Studie anzuwenden
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for comparison is Progression Free Survival (PFS) using the assessment of the progressive disease according to malignant lymphoma criteria by a RAC.
    Das progressionsfreie Überleben (PFS) wird anhand der Beurteilung der progressiven Erkrankung nach malignen Lymphomen Kriterien von einem Komitee (RAC) bewertet.
    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.
    Tumorbewertung (klinische Untersuchung, Labortests, Becken, Bauch, Brust und Hals-CT-Untersuchung, Untersuchung des Knochenmarks) werden zu Beginn der Studie, in der Mitte nach 3 Zyklen (nur CT scan) und 4 Wochen nach der letzten Behandlungsdosis durchgeführt. Um die Vergleichbarkeit der Methoden zur Reaktionsbeurteilung zu Beginn der Studie und währenddessen zu gewährleisten, werden diese unter Verwendung von identischen Techniken durchgeführt.
    Für die Follow-up-Bewertung, einschließlich CT Scan, wird ein klinischer Besuch alle 3 Monate im ersten Jahr, dann alle 4 Monate im 2. Jahr und danach alle 6 Monate notwendig sein.
    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
    • Gesamtüberleben
    • Gesamtansprechrate (ORR [PR + CR + CRu]) (gemäß den Ansprechkriterien für maligne Lymphome 1999)
    • Dauer des Ansprechens
    • Zeit bis zur Progression
    • Zeit bis zum Therapieversagen
    • Sicherheit
    • Lebensqualität (QoL)
    • Ansprechraten nach histologischen PTCL-Subtypen
    • Ansprechrate nach prognostischen Standardparametern
    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
    • Gesamtüberleben: 2 Jahre nach dem Ende der Behandlung
    • Gesamtansprechrate (ORR [PR + CR + CRu]): am Ende der Behandlung
    • Dauer des Ansprechens: während der Dauer der Studie
    • Zeit bis zur Progression: während der Dauer der Studie
    • Zeit bis zum Therapieversagen: während der Dauer der Studie
    • Sicherheit: während der Dauer der Studie
    • Lebensqualität (QoL): Bei der Randomisierung, an D1 des Zyklus 4, bei der Auswertung am Ende der Behandlung und während des Follow-up alle 3 Monate das erste Jahr, alle 4 Monate das zweite Jahr und jedes Jahr während des Follow-up Zeit bis zur Primäranalyse
    • Ansprechraten von histologischen PTCL-Subtypen: am Ende der Behandlung
    • Ansprechrate durch prognostischen Standardparametern: am Ende der Behandlung
    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
    Romidepsin zusammen mit CHOP im Vergleich zur Gabe von CHOP alleine
    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 concerned4
    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
    Austria
    Belgium
    Czech Republic
    France
    Germany
    Italy
    Korea, Democratic People's Republic of
    Portugal
    Singapore
    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.
    Das Ende der Studie wird auch gleichzeitig das Ende des Follow-up sein, ca. 5 Jahre nachdem der letzte Patient randomisiert wurde.
    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
    E.8.9.2In all countries concerned by the trial months6
    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 state15
    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.
    Keine Unterschiede.
    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 Decision2015-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-13
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