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    Summary
    EudraCT Number:2009-013619-36
    Sponsor's Protocol Code Number:SINTRA-REV
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-07
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2009-013619-36
    A.3Full title of the trial
    Multicenter, randomized, double-blind, phase III study of REVLIMID
    (Lenalidomide) versus placebo in patients with low risk myelodysplastic syndrome (low and intermediate-1 IPSS) with alteration in 5q- and anemia without the need of transfusion.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter, randomized, double-blind, phase III study of REVLIMID
    (Lenalidomide) versus placebo in patients with low risk myelodysplastic syndrome (low and intermediate-1 IPSS) with alteration in 5q- and anemia without the need of transfusion.
    A.3.2Name or abbreviated title of the trial where available
    SINTRA-REV
    A.4.1Sponsor's protocol code numberSINTRA-REV
    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 SponsorFundación General de la Universidad de Salamanca
    B.1.3.4CountrySpain
    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 supportFundación General de la Universidad de Salamanca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación General de la Universidad de Salamanca
    B.5.2Functional name of contact pointMiguel Angel Salinero Rodero
    B.5.3 Address:
    B.5.3.1Street AddressC/ Fonseca, 2
    B.5.3.2Town/ citySalamanca
    B.5.3.3Post code37002
    B.5.3.4CountrySpain
    B.5.4Telephone number0034923 29 47 72
    B.5.5Fax number0034923 29 47 02
    B.5.6E-mailsalinero@usal.es
    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 5 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/192
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    D.3.2Product code Revlimid
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeLEN
    D.3.9.3Other descriptive nameRevlimid
    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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients who are 18 years old or older, who suffer from low risk myelodysplastic syndrome associated to the loss of 5q without transfusion requirements
    E.1.1.1Medical condition in easily understood language
    Patients who are 18 years old or older, who suffer from low risk myelodysplastic syndrome associated to the loss of 5q without transfusion requirements
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10067096
    E.1.2Term 5q minus myelodysplastic syndrome
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess if treatment with Revlimid (Lenalidomide) extends the period until the progression to MDS del(5q) considered as transfusión independent, documented verification that the patient suffering from anemia due to MDS requires transfusion of at least 2 UCH/56
    days (2 months) with a minimum follow up of 112 days (4 months). Revlimid will be compared to the current standard treatment for patients with low risk MDS associated with the loss of 5q without transfusion dependent anemia, which is the therapeutic abstention and monitoring until its progression.
    E.2.2Secondary objectives of the trial
    - Erythroid response
    - Duration of the red blood cells transfusion independency
    - Change of hemoglobin concentration (Hb) in relation to baseline levels of patients who show erythroid response.
    - Variation in platelets absolute count in relation to baseline levels.
    - Variation in neutrophils absolute count in relation to baseline levels.
    - Cytogenetic response according to the Criteria of the MDS International Work Team.
    - Bone marrow response.
    - To assess the safety and tolerance of the Lenalidomide scheme, measured according to the incidence of clinical and laboratory toxicity.
    - Global survival, Event Free Survival and Rate of Transformation to Acute Leukemia.
    - Time from diagnose to transfusion independence.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TP53 gene biological substudy
    versión 01, dated April 24th 2013
    - Primary objective: Describe the mutational status of TP53 in patients included in SINTRA-REV study, at the time of diagnosis and anually during trial treatment and follow up.
    - Secondary objective: try to correlate TP53 mutational status with Lenalidomide treatment response as well as disease evolution.
    E.3Principal inclusion criteria
    - The patient must, to the understanding of the investigator, be capable of meeting all requirements of the clinical trial.
    - The patient will have to freely sign the informed consent before undergoing any test of the trial which does not form part of the normal care of patients, knowing the patient that he/she can leave the trial at any time, without this damaging in any way his/her subsequent medical attention.
    - Age > 18 years.
    - The patient will have to have a diagnose of low risk MDS (low and intermediate-1 IPSS) associated to the loss of 5q, either as isolated abnormality or accompanied by other additional cytogenetic abnormalities.
    - MDS del(5q) with anemia (Hb ? 12 g/dL) transfusion independent, documented confirmation of not having received any transfusion of packed red blood cells due to his/her baseline disease (MDS).
    - The patient will have a general state measured according to the ECOG scale ? 2.
    - Be capable of meeting all scheduled visits of the study.
    - All woman patient with childbearing potential will have to understand the teratogenic risk of the drug under study and commit herself to and be capable of fulfilling it, to use an effective contraceptive method.
    E.4Principal exclusion criteria
    - Any organic disease or psychiatric disorder which made possible that the patient did not sign nor understood the informed consent.
    - Having received any treatment for MDS.
    - MDS del(5q) with transfusion dependent anemia, documented confirmation that the patient has received some CH transfusion due to the baseline disease (MDS).
    - Pregnant women or on lactation period.
    - Any of the following lab abnormalities: Absolute count of neutrophils < 500/mm3, Platelet count < 25000/mm3, GOT or GPT in serum > 3 times the normal higher threshold, Total serum bilirubin > 2 times the normal higher threshold.
    - Prior history of other malign disease different to MDS (except for carcinoma of baseline cells or skin squamous, or cervix or breast in situ carcinoma) unless the patient is free from disease for more than 5 years.
    - Know hypersensibility or history of uncontrollable side effects to Lenalidomide.
    - Major surgery within the 4 weeks prior to the inclusion in the trial.
    - The patient has received any agent under research in the 30 days prior to the inclusion.
    - Known positivity for HIV; active or chronic hepatitis A, B or C infection (including patients who are tested anti-HBC positive and/or HBsAg positive) – serological testing for hepatitis A, B, C required.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy end point:
    - Progression free survival time until MDS with transfusion dependent anemia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression of disease will be confirmed when a patient becomes transfussion dependent due to MDS.
    E.5.2Secondary end point(s)
    - Erythroid response
    - Duration of the red blood cells transfusion independency
    - Change of hemoglobin concentration (Hb) in relation to baseline levels of patients who show erythroid response.
    - Variation in platelets absolute count in relation to baseline levels.
    - Variation in neutrophils absolute count in relation to baseline levels.
    - Cytogenetic response according to the Criteria of the MDS International Work Team.
    - Bone marrow response.
    - To assess the safety and tolerance of the Lenalidomide scheme, measured according to the incidence of clinical and laboratory toxicity.
    - Global survival, Event Free Survival and Rate of Transformation to Acute Leukemia.
    - Time from diagnose to transfusion independence.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cointinuosly through the study visits
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    After the 2 years treatment period, patients will begin long period follow up phase for 2 additional years.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 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 2014-11-07. 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 60
    F.4.2.2In the whole clinical trial 60
    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)
    Regular clinical practice
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-02
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