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    Summary
    EudraCT Number:2007-007698-22
    Sponsor's Protocol Code Number:R2-CHOP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-007698-22
    A.3Full title of the trial
    A PHASE IB/II STUDY OF ESCALATING DOSES OF REVLIMID IN ASSOCIATION WITH R-CHOP (R2-CHOP) IN THE TREATMENT OF B-CELL LYMPHOMA
    A.3.2Name or abbreviated title of the trial where available
    R2-CHOP
    A.4.1Sponsor's protocol code numberR2-CHOP
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGELARC
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    B cell lymphoma
    MedDRA Classification
    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 Phase Ib part of the study is to determine the recommended dose (RD) of lenalinomide (Revlimid) when administered in association with R-CHOP.
    The primary objective of the Phase II part of the study is to assess the efficacy of the association of Revlimid and R-CHOP in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To assess the safety of the association,
    • To assess the efficacy of the association: overall response rate and complete response rate, progression free survival, response duration and overall survival.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A PHASE IB STUDY OF ESCALATING DOSES OF REVLIMID IN ASSOCIATION WITH R-CHOP (R2-CHOP) IN THE TREATMENT OF B-CELL LYMPHOMA :
    The primary objective of the Phase Ib part of the study is to determine the recommended dose (RD) of lenalinomide (Revlimid) when administered in association with R-CHOP.
    The secondary objectives of this study are:
    • To assess the safety of the association,
    • To assess the efficacy of the association: overall response rate and complete response rate, progression free survival, response duration and overall survival.

    A PHASE II STUDY OF REVLIMID IN ASSOCIATION WITH R-CHOP (R2-CHOP) IN THE TREATMENT OF B-CELL LYMPHOMA :
    The primary objective of the Phase II part of the study is to assess the efficacy of the association of Revlimid and R-CHOP in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment.
    The secondary objectives of this study are:
    • To assess the safety of the association,
    • To assess the efficacy of the association: overall response rate and complete response rate, progression free survival, response duration and overall survival.
    E.3Principal inclusion criteria
    • Phase IB: Patients with one of the following B-cell Lymphoma, CD 20 positive:
    o Mantle cell, Marginal zone, follicular
    o Histological transformation from low grade to high grade
    o Diffuse large B cell

    • Phase II: Patients with follicular lymphoma, WHO grade 1, 2 or 3a with at least one of the following signs requiring initiation of treatment:
    o Bulky disease according to the GELF criteria: nodal or extra-nodal mass >7cm in its greater diameter
    o B symptoms
    o Elevated serum LDH or beta 2-microglobulin
    o Involvement of at least 3 nodal sites (each >3cm)
    o Symptomatic spleen enlargement
    o Compressive syndrome
    o Pleural or peritoneal effusion
    • Aged from 18 to 70 years
    • WHO performance status 0, 1 or 2
    • Signed inform consent
    • Life expectancy of ≥ 90 days (3 months).
    • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
    • Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
    † A female patient is considered to have childbearing potential unless she meets at least one of the following criteria 1) Age > 50 years and naturally amenorrhoeic for > 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential); or 2) Premature ovarian failure confirmed by a specialist gynaecologist or 3) Previous bilateral salpingo-oophorectomy, or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis.
    E.4Principal exclusion criteria
    • Previous treatment with immunotherapy or chemotherapy except:
    o Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion
    o Rituximab alone during less than three months, if stopped more than one year before inclusion
    • Previous radiotherapy except if localized to one lymph node area
    • Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative
    • Central nervous system or meningeal involvement
    • Contraindication to any drug contained in the chemotherapy regimen
    • HIV disease, active hepatitis B or C
    • Any serious active disease or co-morbid medical condition (according to investigator’s decision)
    • Any of the following laboratory abnormalities.
    o Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
    o Platelet count < 100,000/mm3 (60 x 109/L).
    o Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
    o Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia.
    • Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min
    • 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) unless the subject has been free of the disease for ≥ 3 years
    • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
    • Pregnant or lactating females.
    • Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide.
    • Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
    • Subjects with ≥ Grade 2 neuropathy.
    • Prior use of lenalidomide.
    Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the phase IB part of the study is the determination of the Recommended Dose of lenalidomide (Revlimid) in combination with R-CHOP regimen. Therefore, primary analysis will be based on safety parameters and particulary on incidence of DLTs as defined in section 7.3. Frequency of patients with DLT during the first 2 cycles of R2-CHOP will be reported by dose level.
    Toxicities related to study regimen and occurring during the assessment period will be reviewed to confirm if they were dose limiting according to protocol and initial patient condition (pre-existing signs and symptoms, medical history). A listing will provide the description of DLTs observed by dose level.

    The primary endpoint for the phase II part of the study is the Complete Response Rate (CR+CRu) at the end of treatment. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin’s lymphoma (Cheson, 1999, section 11.2.1). Response at the end of treatment will be assessed at the end of complete treatment if patient received all planned cycles or at withdrawal. Patient without response assessment (due to whatever reason) will be considered as non-responder. A descriptive analysis will also be performed considering as non-responders all patients who relapsed or died during treatment phase even if they were prematurely withdrawn as responder.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    determination of the Recommended Dose of lenalidomide (Revlimid) in combination with R-CHOP regimen
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned20
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    Last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state110
    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 Decision2008-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-23
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