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    Summary
    EudraCT Number:2011-001356-10
    Sponsor's Protocol Code Number:Revail
    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:2011-10-24
    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 number2011-001356-10
    A.3Full title of the trial
    STUDY OF THE EFFICACY AND SAFETY OF FIRST LINE TREATMENT
    WITH CHOP AND LENALIDOMIDE (Rev-CHOP) IN PATIENTS AGED
    FROM 60 TO 80 YEARS WITH PREVIOUSLY UNTREATED
    ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF THE EFFICACY AND SAFETY OF TREATMENT
    WITH CHOP AND LENALIDOMIDE (Rev-CHOP) WITH PREVIOUSLY UNTREATED
    ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL).
    A.3.2Name or abbreviated title of the trial where available
    Revail
    A.4.1Sponsor's protocol code numberRevail
    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.4.2CountryFrance
    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 Manager
    B.5.3 Address:
    B.5.3.1Street AddressCentre Hospitalier Lyon-Sud Secteur Sainte-Eugénie Pavillon 6D
    B.5.3.2Town/ cityPierre-Bénite Cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)472669333
    B.5.5Fax number+33(0)472669371
    B.5.6E-mailchloe.gourc-berthod@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 Revlimid (lenalidomide)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    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 Revlimid (lenalidomide)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Angioimmunoblastic T-cell Lymphoma (AITL)
    E.1.1.1Medical condition in easily understood language
    T lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002449
    E.1.2Term Angioimmunoblastic T-cell lymphoma
    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
    Complete Metabolic Response (CMR) rate at the end of treatment defined
    according to Lugano Classification (Cheson et al, 2014, PET-CT-Based response)
    E.2.2Secondary objectives of the trial
    - Complete response (CR) rate at the end of treatment according to the IWC
    (International Harmonization Project – Cheson 2007,) as assessed by site
    Investigator.
    - Progression-free survival at 2 years (2y-PFS), events being relapse for complete responders, disease progression, and death from any cause.
    - Overall survival (OS) and event-free survival (EFS)
    - To evaluate the role of PET in defining an accurate staging
    - To evaluate the tumor metabolic activity based on FDG avidity measured by SUV max at baseline and the decrease of SUV max at the end of treatment
    - To correlate response rate, survival and biological factors (phenotype, EBV status, T/B clonality, circulating cytokine dosages).
    - An additional objective is to favour the banking of tumor cells suspensions (from lymph node biopsies, PB, effusions,…)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with histologically proven T-cell angioimmunoblastic lymphoma (AITL)
    • Age from 60 to 80 years.
    • ECOG performance status 0 to 2.
    • No previous therapy (except corticosteroids providing they have been initiated less than 15 days before inclusion).
    • Spontaneous life expectancy > 1 month.
    • Written informed consent. The Lenalidomide Information Sheet (in appendix of the Patient Informed Consent Form) given to each patient receiving lenalidomide study therapy, must be read prior to starting treatment and at each new supply of study drug.
    • Male patients must:
    Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
    Agree to not give semen or sperm during study drug therapy and for a period after end of study drug therapy.
    • All patients must:
    Have an understanding that the study drug could have a potential teratogenicity.
    Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
    Agree not to share study medication with another person.
    Be counselled about pregnancy precautions and risks of foetal exposure.
    E.4Principal exclusion criteria
    • Other categories of T-cell lymphoma.
    • Central nervous system involvement by lymphoma.
    • Any previous therapy for lymphoma except short-term corticosteroids (maximum 10 days) before inclusion.
    • Contra-indication to any drug included in the CHOP regimen.
    • Serious medical or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator’s decision).
    • Active bacterial, viral or fungal infection, in particular active hepatitis B or C and HIV positive serological test.
    • Impaired renal function (Creatinine clearance < 50 ml/min),as calculated by the Cockcroft-Gault formula) or impaired liver function tests (total bilirubin level > 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma.
    • Poor bone marrow reserve as defined by neutrophils < 1.0 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration.
    • Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix.
    • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
    • Hypersensitivity to the active substance or to any of the excipients.
    • Pregnant and lactating woman
    • Females of Childbearing potential (FCBP*) according to the PPP (in appendix 18.13 of the protocol)
    *A FCBP isa female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the Complete Response (CR) rate at the end of treatment according to Cheson 2007 criteria and based on PET scan independent central review.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of treatment
    E.5.2Secondary end point(s)
    - Efficacy endpoints
    Secondary efficacy endpoints will include:

    * PROGRESSION-FREE SURVIVAL (PFS)
    Progression-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse or death from any cause, whichever occurs first.
    Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.

    * OVERALL SURVIVAL (OS)
    Overall survival will be measured from the date of inclusion to the date of death from any cause. Patients alive will be censored at their last follow-up date. Patients who are alive or lost to follow-up at the time of analysis will be censored at the date of the last contact.

    * EVENT-FREE SURVIVAL (EFS)
    Event-Free Survival will be measured from the date of inclusion to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause. Responding patients and patients who are lost to follow up will be censored at their last tumor assessment date.

    - Safety endpoints
    All subjects who received at least one dose of Revlimid will be considered evaluable and analyzed for safety.
    Analysis of safety will be performed by summarizing adverse events, laboratory data, physical examination findings and vital signs. When applicable, summary of safety data will also be performed by cycle.

    - Exploratory analyses
    All other analyses (like subgroup analyses, role of PET scan, biological studies, prognostic factors) will be considered as exploratory analyses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of treatment
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Patients will be followed until 18 months after the last patient inluded.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months78
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months78
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    Treatment will not be different than the current practice in this population in case of progression or relapse.
    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 Decision2011-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-21
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