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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-009372-13
    Sponsor's Protocol Code Number:2009-01b
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-09-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-009372-13
    A.3Full title of the trial
    A phase II, multi-center, open-label, repeat-dose study of Lenalidomide (Revlimid ®) plus low-dose Dexamethasone in patients with refractory B-cell lineage acute lymphoblastic leukemia or in relapse after two lines of treatment
    (RV-405 LAL)
    A.3.2Name or abbreviated title of the trial where available
    RV-405 LAL
    A.4.1Sponsor's protocol code number2009-01b
    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 SponsorInstitut de Cancérologie de la Loire
    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 25 mg capsules
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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 Information not present in EudraCT
    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
    Treatment for B-cell Acute lymphoblastic leukemia in relapse.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of lenalidomide plus low-dose dexamethasone : CR (complete response), CRp(complete response without platelet reconstitution), PR (partial response), and overall response (CR+CRp+PR)
    E.2.2Secondary objectives of the trial
    • To assess the safety of lenalidomide plus dexamethasone: adverse events (type, frequency, severity of adverse events, and relationship of adverse events to study drug).
    • To determine the time to response.
    • To determine the duration of response.
    • To determine the progression-free survival.
    • To determine the QOL: European Organization for Research and Treatment of Cancer QOL questionnaire for patients with cancer (EORTC QLQ-C30).
    • To determine the feasibility of SCT, in case of response, after one or more cycles of lenalidomide plus dexamethasone therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Documented B-cell lineage ALL (non-Ph+), which under WHO guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma.
    • Must have failed to at least two treatments regimens for B-lineage ALL. The inclusion of a patient can be allowed after contacting the principal investigator. Similarly, the inclusion of a patient with Ph+ ALL can be possible or must be refractory to chemotherapy. The inclusion of a patient with Ph+ All can be possible after contacting the principal investigator in presence of a T315I mutation and absence of investigational trial targeting this abnormality.
    • Performance status of  2 by ECOG criteria.
    • Any age  18 years is allowed.
    • Life expectancy of at least 3 months.
    • Adequate liver function (AST and/or ALT not > 3 times upper limits of normal).
    • Adequate kidney function (calculated creatinine clearance > 50 ml/min).
    • Signed informed consent prior to start of any study-specific procedures
    * Negative Pregnancy test performed in the 3 days prior to the study
    * Effective contraception without interruption for female subject of childbearing potential
    E.4Principal exclusion criteria
    • Active serious infection not controlled by oral or intravenous antibiotics.
    • Treatment with any investigational antileukemic agent or chemotherapy agent in at least 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given.
    • Rapidly progressive disease with compromised organ function judged to be life-threatening by the Investigator.
    • Patients with clinical evidence of active CNS disease.
    • Pregnant and/or lactating female.
    • Patients with known HIV infection.
    • Patients with known active hepatitis B and/or hepatitis C infection.
    • Hypersensitive or intolerant to any component of the study drug formulation.
    E.5 End points
    E.5.1Primary end point(s)
    Bone marrow aspirate will be performed at the end of each cycle in order to assess response to therapy and document leukemic status. Efficacy of the lenalidomide-dexamethasone combination in inducing remissions will be assessed primarily by the calculation of three response rates: CR, CRp, and RP. <response rates will be presented with 95% confidence intervals (two-tailed).

    A response to treatment will be defined as the following:
    • CR is defined as no evidence of circulating blasts or extramedullary disease, a bone marrow with  5% blasts, and recovery of peripheral counts (platelets  100,000/mm3 and absolute neutrophil count  1000/mm3).
    • CRp is defined as meeting all criteria for CR except for recovery of platelet counts to  100,000/mm3.
    • PR is defined as complete disappearance of circulating blasts, a bone marrow with > 5% to  25% blasts, and appearance of normal progenitor cells or a bone marrow with  5% blasts that did not qualify for CR or CRp.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Information not present in EudraCT
    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 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 concerned4
    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
    Conditions of the end of the study include the discovery of an unexpected, serious or unacceptable risk to the patients enrolled in the study. The Data and Safety monitoring board (DSMB), consisting of independent clinical oncologists will evaluate safety and efficacy data in an ongoing, periodic manner. Safety reviews will occur at scheduled intervals no less than four per year. A formal review meeting will be held following first cycle of treatment in five patients.
    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 months6
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    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 Decision2009-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-24
    P. End of Trial
    P.End of Trial StatusOngoing
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