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    The EU Clinical Trials Register currently displays   42880   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-006177-32
    Sponsor's Protocol Code Number:CC-5013-MCL-003
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-10-16
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-006177-32
    A.3Full title of the trial
    A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, FIRST LINE MAINTENANCE STUDY OF LENALIDOMIDE (REVLIMID®) IN PATIENTS WITH MANTLE-CELL LYMPHOMA
    A.3.2Name or abbreviated title of the trial where available
    The RENEW trial
    A.4.1Sponsor's protocol code numberCC-5013-MCL-003
    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 SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 5mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    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) 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.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 10mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    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) 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.IMP: 3
    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 15mg, hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.2Current sponsor codeCC-5013
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mantle-Cell Lymphoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).
    E.2.2Secondary objectives of the trial
    To evaluate the safety of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with MCL who are not candidates for transplantation and have achieved partial or complete response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must understand and voluntarily sign an informed consent form

    2. Must be ≥ 18 years of age at the time of signing the informed consent form

    3. Must be able to adhere to the study visit schedule and other protocol requirements

    4. Histologically-proven mantle cell non-Hodgkin’s lymphoma, including evidence of cyclin D1 overexpression by immunohistochemistry. In patients whose tumors are negative for the cyclin D1 overexpression, evidence of overexpression of cyclin D2 or D3 by immunohistochemistry will be acceptable

    5. Must have received one of the following first-line induction chemotherapy regimens with rituximab:
    a. A combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid. For example: R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), R-CHOP 14, R-CHOP 21; (minimum of 6 full dosed cycles up to maximum 8 cycles). Regimens containing cytarabine, or methotrexate are not allowed.
    b. Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide) (minimum of 6 full dosed cycles)
    c. Patients who have been treated with less than 6 cycles of R-CHOP or R-FC, but received ≥4 cycles, can be considered eligible if dose reduction or treatment discontinuation occurred due to severe drug related toxicity, including, but not limited to: cardiac insufficiency, neurotoxicity, drug induced or worsened diabetes mellitus, repetitive febrile neutropenia and severe infections despite appropriate growth factor support, life threatening allergic reactions and the physician considers that adequate treatment has been delivered
    d. Clinically appropriate dose modifications of vincristine or prednisone in the first-line induction chemotherapy regimen will be allowed if occurred in cycles ≥4

    6. Must have completed the first-line induction chemotherapy regimen and achieved a PR or better response as assessed by 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007)

    7. Must have completed last dose of first-line induction chemotherapy no less than 4 weeks (28 days) and no later than 12 weeks (84 days) prior to randomization

    8. Patients whom the physician considers ineligible for transplant at the time of enrollment because of one of the following reasons:
    a. Age ≥ 65 years
    b. Comorbidity for patients < 65 years
    Comorbidity is defined as any condition including laboratory abnormalities or clinical symptoms such as e.g. cardiac insufficiency and severe pulmonary diseases that places the patient at an unacceptable risk if he/she undergoes transplant
    c. Patient declines transplant

    9. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at the time of screening

    10. Female of child bearing potential must:
    a. Have two negative medically supervised urine pregnancy test prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the patient practices complete and continued sexual abstinence
    b. Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy

    11. Male patients must:
    a. 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
    b. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy

    12. All patients must:
    a. Have an understanding that the study drug could have a potential teratogenic risk
    b. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy
    c. Agree not to share study medication with another person
    d. Be counseled about pregnancy precautions and risks of fetal exposure.
    E.4Principal exclusion criteria
    1. Histology other than MCL, for example transformed lymphoma, Burkitt lymphoma, diffuse large B-cell lymphoma (DLBCL), T-cell lymphoma

    2. Patients who do not have archival tumor samples and who do have no tumor accessible for biopsy are not eligible into the study

    3. Patients who have received more than 1 line of induction chemotherapy

    4. Patients who received 1st line induction therapy other than those specified in inclusion criteria or had treatment modification as follows:
    a. Addition of new drugs to the first-line induction chemotherapy specified in inclusion criteria will not be allowed. For example, addition of cytarabine or methotrexate to R-CHOP/R-CHOP-like etc will not be allowed
    b. Switching of regimens in the middle of induction treatment will not be allowed. For example, CHOP to FC or CHOP to CVP (cyclophosphamide, vincristine, and prednisone), etc will not be allowed
    c. Use of any agents as "maintenance" following completion of initial combination chemotherapy are not allowed

    5. Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible

    6. Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy

    7. Any of the following laboratory abnormalities:
    a. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)
    b. Platelet count < 60,000/mm3 (60 x 109/L)
    c. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
    d. Serum bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma

    8. Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min

    9. Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma

    10. Patients should not be receiving corticosteroids except for prednisone ≤ 10 mg/day or equivalent for purposes other than treating MCL

    11. Patients at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis

    12. Prior history of malignancies other than MCL unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
    a. Basal cell carcinoma of the skin
    b. Squamous cell carcinoma of the skin
    c. Carcinoma in situ of the cervix
    d. Carcinoma in situ of the breast
    e. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)

    13. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form

    14. Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible

    15. Pregnant or lactating females

    16. Uncontrolled intercurrent illness including, but not limited to:
    a. Ongoing or active infection requiring parenteral antibiotics
    b. Uncontrolled diabetes mellitus as defined by the investigator
    c. Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart Association Classification for Heart Disease)
    d.Unstable angina pectoris, angioplasty, stenting, or myocardial infarctions within 6 months
    e. Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. Patients with controlled atrial fibrillation that is asymptomatic are eligible

    17. Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide

    18. Desquamating (blistering) rash while taking thalidomide

    19. Prior use of lenalidomide

    20. Use of any standard or experimental anti-cancer drug therapy or radiation within 3 weeks of the initiation (Day 1) of study drug therapy

    21. Participation in another clinical trial during the screening/baseline phase and treatment phase of the study
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 EEA97
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Study will be terminated when either 80% of patients have died or 5-years after last patient is randomised, whichever comes first
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-10-16. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 333
    F.4.2.2In the whole clinical trial 450
    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)
    See protocol
    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 Decision2009-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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