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    Summary
    EudraCT Number:2012-002795-13
    Sponsor's Protocol Code Number:RG_12-129
    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:2012-10-24
    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 number2012-002795-13
    A.3Full title of the trial
    A phase II trial of Cyclosporin A in Early Adverse Risk CLL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early phase trial of Cyclosporin A in patients with early stage Chronic Lymphocytic Leukaemia (CLL) who do not currently require treatment.
    A.3.2Name or abbreviated title of the trial where available
    CyCLLe
    A.4.1Sponsor's protocol code numberRG_12-129
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN61297219
    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 SponsorUniversity of Birmingham
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointSonia Fox
    B.5.3 Address:
    B.5.3.1Street AddressCRCTU, University of Birmingham,
    B.5.3.2Town/ cityEdgbaston, Birmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214143289
    B.5.5Fax number01214143700
    B.5.6E-mails.fox.2@bham.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 Neoral Soft Gelatin Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK Ltd
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNeoral Soft Gelatin Capsules
    D.3.2Product code Ciclosporin A
    D.3.4Pharmaceutical form Capsule, soft
    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 INNCiclosporin A
    D.3.9.1CAS number 59865-13-3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Lymphocytic Leukaemia
    E.1.1.1Medical condition in easily understood language
    Leukaemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10068919
    E.1.2Term B-cell chronic lymphocytic leukemia
    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 investigate the effects of CsA on tumour kinetics in patients with CLL.
    E.2.2Secondary objectives of the trial
    • Toxicity of CsA in patients with CLL (toxicities will be measured and graded according to CTCAE criteria v4).
    • Spontaneous intra-patient variation in the proliferation (growth), release and loss of CLL cells from the circulation.
    • Time to the maximum release of labelled CLL cells into the circulation with CsA therapy.
    • Rate of loss of labelled CLL cells from the circulation with CsA therapy
    • Complete response rate* - Complete Remission after 8 weeks and 6 months CsA
    • Overall response rate* (Complete Remission + Partial Remission) after 8 weeks and 6 months of CsA

    Translational outcome measures:
    • Stability of unsorted CLL cells for 2H-Glu proliferation assays to assess the feasibility of future multi-site studies, i.e. do the samples need to be sorted at site and frozen or could they be sorted centrally with 24 hours without loss of quality.

    If funding allows, the following translational outcome will be assessed:
    Effect of CsA on:
    Phenotype and activation sta
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Stage A or B CLL (Binet system) not requiring therapy by conventional criteria
    • ≤ 2 lines of previous therapy for CLL
    • Age ≥18
    • ECOG performance status ≤2
    • Life expectancy >12 months
    • No therapy for CLL in previous 3 months (including glucocorticoids)
    • CD38+ve; ≥ 7%
    • Normal renal function (eGFR >60mls/min)
    • Normal liver function (AST and / or ALT <1.5 ULN)
    • Negative serology for Hepatitis B, C and HIV
    • Valid informed consent
    E.4Principal exclusion criteria
    • Active infection
    • Active autoimmune disease (requiring therapy)
    • Diabetes Mellitus
    • Previous myocardial infarction or history of cardiac dysrhythmia.
    • Uncontrolled hypertension
    • Taking medication known to cause serious interaction with CsA where the interaction cannot be prevented by monitoring and adjusting CsA level
    • Fludarabine refractory disease (Non response to or relapse within 6 months of fludarabine containing regimen)
    • Previous bone marrow transplant
    • History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
    • Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
    • Patients and partners of childbearing potential not willing to use effective contraception during and for 3 months after therapy
    E.5 End points
    E.5.1Primary end point(s)
    Change in proliferation rate of CLL cells from day 0 of cycle 2 to day 56 (after 4 weeks of CsA therapy) will measured by deuterated glucose incorporation
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome will be evaluated after all patients have received treatment with Cyclosporin A for 4 weeks.
    E.5.2Secondary end point(s)
    Secondary outcome measures:
    • Toxicity of CsA in patients with CLL (toxicities will be measured and graded according to CTCAE criteria v4).
    • Spontaneous intra-patient variation in the proliferation, release (optional) and loss of CLL cells from the circulation.
    • Effect of CsA on the release of labelled CLL cells into the circulation (optional).
    • Effect of CsA on the loss of labelled CLL cells from the circulation
    • Complete response rate* - Complete Remission after 8 weeks and 6 months CsA
    • Overall response rate* (Complete Remission + Partial Remission) after 8 weeks and 6 months of CsA
    *Response as defined by the guidelines from the International Workshop on Chronic Lymphocytic Leukemia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary outcome will be analysed 2 months after the last patient has completed Cyclosporin A therapy.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Biological Study
    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 No
    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) 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 concerned2
    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
    LVLS plus 6 months for final data cleaning
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    The intervention will be provided from standard hospital stock during the trial. The local investigator will decide on the best course of treatment once the research has finished. This may involve an additional 4 months of Cyclosporin A therapy if clinically indicated.
    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 Decision2012-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-04
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