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    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-005101-29
    Sponsor's Protocol Code Number:KCH-MDS-04-1.0
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-005101-29
    A.3Full title of the trial
    THE EFFICACY AND SAFETY OF LENALIDOMIDE (Revlimid®) MONOTHERAPY IN RED BLOOD CELL TRANSFUSION DEPENDENT SUBJECTS WITH MYELODYSPLASTIC SYNDROME ASSOCIATED WITH A DEL (5q) CYTOGENETIC ABNORMALITY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of the study is to determine if the drug lenalidomide (Revlimid®) is able to improve anaemia (low red blood count) and reduce the number of blood transfusions that you require because of Myelodysplastic Syndrome (MDS). The other purpose of the study is to evaluate the effect of the study drug (lenalidomide) on the genetic abnormality (changes in the cell characteristics) associated with MDS.
    A.3.2Name or abbreviated title of the trial where available
    Revlimid in MDS with 5q- cytogenetic abnormality
    A.4.1Sponsor's protocol code numberKCH-MDS-04-1.0
    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 SponsorKing's College Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportKing's College Hospital NHS Foundation Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointProfessor Ghulam Mufti
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Haematological Medicine, King's College Hospital, Denmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00440203299 3080
    B.5.5Fax number00440207346 3514
    B.5.6E-mailghulam.mufti@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportKing's College Hospital NHS Foundation Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProfessor Ghulam Mufti
    B.5.3 Address:
    B.5.3.1Street AddressDenmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402032993080
    B.5.5Fax number004402073463514
    B.5.6E-mailghulam.mufti@kcl.ac.uk
    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 Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameRevlimid
    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
    Myelodysplastic Syndrome (MDS) associated with a Del (5q) cytogenetic abnormality
    E.1.1.1Medical condition in easily understood language
    MDS is a disease of the bone marrow, in which the production of blood cells slows down considerably. This syndrome carries a risk of developing leukaemia.
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10067097
    E.1.2Term 5q minus MDS
    E.1.2System Organ Class 100000004864
    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 treatments to achieve haematopoietic improvement in subjects with low- or intermediate-1 risk International Prognostic Scoring System1 (IPSS) myelodysplastic syndrome (MDS) associated with a del 5q cytogenetic abnormality
    To evaluate the efficacy of lenalidomide to achieve haematopoietic improvement in patients with isolated del5q with blasts <20%
    E.2.2Secondary objectives of the trial
    To evaluate the safety of lenalidomide treatments in MDS subjetcs with a del5q cytogenetic abnormality.
    To attempt to determine further the genetic and cellular changes involved with the development of the 5q- syndrome and the effects of lenalidomide (Revlimid®) upon these cells
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Understand and voluntarily sign an informed consent form.
    2. Age >18 years at the time of signing the informed consent form.
    3. Able to adhere to the study visit schedule and other protocol requirements.
    4. Diagnosis of low- or intermediate-1-risk (IPSS) MDS associated with a del(5q) cytogenetic abnormality. The del(5q) cytogenetic abnormality may be an isolated finding or may be associated with other cytogenetic abnormalities and if del5q is an isolated aberration the patient could have up to 20% blasts.
    5. RBC transfusion-dependent anaemia defined as having at least 2 separate transfusion events within the past 112 days.
    6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix I).
    7. Women of childbearing potential (WCBP)† must:
    o Understand the study drug is expected to have a teratogenic risk
    o Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout the entire duration of study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception
    o Implant
    o Levonorgestrel-releasing intrauterine system (IUS)
    o Medroxyprogesterone acetate depot
    o Tubal sterilisation
    o Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
    o Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
    o Understand that even if she has amenorrhea, she must follow all the advice on effective contraception.She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy
    o Agree to have medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml between 14 and 10 days prior to starting drug therapy. In addition, agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml on the day of drug dispensing (prior to starting drug therapy) or within the 24 hours prior to the study visit once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment
    o WCBP must undergo pregnancy testing at intervals described in Appendix 4. These pregnancy tests should be performed on the day of drug dispensing (prior to prescribing lenalidomide) or within the 24 hours prior to the study visit. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
    • Male subjects must
    o Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study drug therapy if their partner is of childbearing potential and has no contraception.
    o Agree not to donate semen or sperm during study drug therapy and for 28 days after end of study drug therapy.
    • All subjects must
    o Agree to abstain from donating blood while taking study drug therapy and for 28 days following discontinuation of study drug therapy.
    8. Laboratory test results within these ranges:
    • Absolute neutrophil count > 0.5 x 109/L
    • Platelet count > 25 x 109/L
    • Serum creatinine < 2.0 mg/dl
    • Total bilirubin < 1.5 mg/dl
    • AST (SGOT) and ALT (SGPT) < 3 x ULN.
    9. Disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in-situ” of the cervix or breast.
    10. Agree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist
    E.4Principal exclusion criteria
    1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
    2. Pregnant or lactating females.
    3. Prior > grade 3 (National Cancer Institute [NCI] Common Toxicity Criteria [CTC]) allergic reaction to thalidomide (Appendix 3).
    4. Prior > grade 3 (NCI CTC) rash or any desquamation (blistering) while taking thalidomide (Appendix 3).
    5. Clinically significant anaemia due to factors such as iron, B12 or folate deficiencies, autoimmune or hereditary haemolysis or gastrointestinal bleeding (if a marrow aspirate is not evaluable for storage iron, transferrin saturation must be > 20 % and serum ferritin not less than 50 ng/ml).
    6. Use of haematopoietic growth factors within 7 days of the first day of study drug treatment. Use of G-CSF is permitted.
    7. Concurrent use of erythropoietin
    8. Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisolone) within 28 days of the first day of study lenalidomide treatment.
    9. Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study lenalidomide treatment.
    10. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for >5 years.
    11. Any prior use of lenalidomide
    12. Concurrent use of other anti-cancer agents or treatments. Patients must not have received any form of chemotherapy for at least 4 weeks prior to study entry and must have fully recovered from haematological toxicity associated with this therapy.
    13. Known positive for HIV or infectious hepatitis, type A, B or C.
    E.5 End points
    E.5.1Primary end point(s)
    Red blood cell (RBC) transfusion independence.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects may remain in the study until bone marrow disease progression or progression/relapse following erythroid haematological improvement
    E.5.2Secondary end point(s)
    • Cytogenetic response
    • >50 % decrease in RBC transfusion requirements
    • Change of haemoglobin concentration from baseline
    • Safety (type, frequency, severity, and relationship of adverse events to lenalidomide)
    • Platelet response
    • Neutrophil response
    • Bone marrow response
    • Duration of response
    • Gene expression profiling of patients with the 5q- syndrome and effects of lenalidomide on gene expression profiles.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects may remain in the study until bone marrow disease progression or progression/relapse following erythroid haematological improvement
    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 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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.7Trial has a data monitoring committee No
    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 last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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 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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 state48
    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)
    Upon discontinuation of treatment with IMP, patients' care will return as per standard clinical practice. Patients will be followed up three monthly as part of survival contact.
    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 Decision2005-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-23
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