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    Summary
    EudraCT Number:2010-023022-20
    Sponsor's Protocol Code Number:CLL2S
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-01
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-023022-20
    A.3Full title of the trial
    A Phase I/II, Multi-centre Trial to Assess the Safety, Efficacy, and Pharmacokinetics of Eltrombopag, Administered to Thrombocytopenic Chronic Lymphocytic Leukemia Patients Prior to Alkylating Agents and/or Purine Analogue-based Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial to assess the safety and efficacy of the medication Eltrombopag, indicated for patients with chronic lymphocytic leukemia along with low platelet counts who are planned to recieve a chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    CLL 2S Trial of the GCLLSG
    A.4.1Sponsor's protocol code numberCLL2S
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01397149
    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 SponsorUniversitätsklinikum Ulm
    B.1.3.4CountryGermany
    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 supportGlaxoSmithKline GmbH & Co KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDeutsche CLL Studiengruppe (DCLLSG)
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKlinik I für Innere Medizin, Uniklinik Köln
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50924
    B.5.3.4CountryGermany
    B.5.4Telephone number+4922147888220
    B.5.5Fax number+4922147886886
    B.5.6E-mailcllstudie@uk-koeln.de
    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 No
    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 nameEltrombopag
    D.3.2Product code SB497115
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNELTROMBOPAG
    D.3.9.1CAS number 496775-61-2
    D.3.9.2Current sponsor codeSB497115
    D.3.9.4EV Substance CodeSUB30140
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.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 No
    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 nameEltrombopag
    D.3.2Product code SB497115
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNELTROMBOPAG
    D.3.9.1CAS number 496775-61-2
    D.3.9.2Current sponsor codeSB497115
    D.3.9.4EV Substance CodeSUB30140
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboCoated tablet
    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 placeboCoated tablet
    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
    CLL patients with thrombocytopenia and indication for chemotherapeutic treatment with alkylating agents and/or purine analogues
    E.1.1.1Medical condition in easily understood language
    CLL patients with low platelet counts and indication for chemotherapeutic standard treatment
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008977
    E.1.2Term Chronic lymphocytic leukemia recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Phase I:
    The primary objective is to find the safe and potentially efficacious dose of eltrombopag to achieve a durable increase in platelet count.
    Phase II:
    The primary objective of phase II is to confirm the effect of the selected dose from Phase I in correcting thrombocytopenia to enable patients to receive alkylating agents and/or purine analogue-based therapy.
    E.2.2Secondary objectives of the trial
    •Safety and tolerability of eltrombopag by evaluating adverse events and changes from baseline in vital signs and clinical laboratory parameters (compared to placebo, phase II)
    •To evaluate the incidence and durability of platelet response (compared to placebo, phase II)
    •To determine the incidence and severity of bleeding events (WHO bleeding scale, compared to placebo, phase II)
    •To analyze the pharmacokinetics and the relationship between pharmacokinetics and pharmacodynamics of eltrombopag and platelet counts (compared to placebo, phase II)
    •To determine the effect of eltrombopag on the use of platelet transfusion(s) to treat thrombocytopenia (compared to placebo, phase II)
    •To evaluate chemotherapy dose delay/dose reduction in eltrombopag groups compared to placebo (phase II)
    •To examine the eltrombopag effect in relation to data on the cause of thrombocytopenia
    •CLL overall response rate & time to progression
    •To evaluate trough-level pharmacokinetics of eltrombopag
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Confirmed diagnosis of CLL (based on immunophenotyping performed at the central reference laboratory of the GCLLSG in Cologne)
    •Platelet count <50 000/µl at time of screening (measured and confirmed once)
    •Patient is planned to receive alkylating agents, bendamustine and/or fludarabine-based therapy
    •ECOG Performance Status of 0-2
    •Age ≥ 18 years
    •Signed written informed consent, according to ICH-GCP, and national/local regulation, prior to performing any study-specific procedures
    •Negative pregnancy test and willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
    •Able to understand and comply with protocol requirements and instructions and intend to complete the study as planned.
    •Adequate renal function (creatinine must not exceed the upper limit of normal (ULN) reference range by more than 50%) at study entry
    •Adequate liver function: bilirubin £ 1.5 times the upper limit of normal. ALT or AST £3 times the upper limit of normal without liver involvement with CLL and £5 times the upper limit of normal in case of the liver involvement with CLL
    •Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range with no history of hypercoagulable state
    •Total albumin must not be below the lower limit of normal (LLN) by more than 20%
    E.4Principal exclusion criteria
    •Thrombocytopenia that is primarily caused by ITP
    •Refractory CLL: defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months of last anti-leukemic therapy , including fludarabine and/or bendamustine. NOTE: Subjects refractory to rituximab monotherapy as last therapy are permitted
    •No prior therapy for CLL
    •Active autoimmune hemolytic anemia (AIHA) requiring corticosteroid therapy >100mg equivalent to hydrocortisone, or chemotherapy
    •Platelet count > 50 000/µl at screening
    •Richter’s transformation
    •CNS involvement of B-CLL
    •Active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
    •Past or current malignancy other than CLL (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless tumor was successfully treated with curative intent at least 2 years prior to trial entry
    •Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months, congestive heart failure, etc.
    •History of significant cerebrovascular disease
    •Recurring venous thrombosis or pulmonary embolism
    •Glucocorticoids unless given in doses ≤ 100 mg/day hydrocortisone (or equivalent dose of other glucocorticoids) and for exacerbations other than CLL (e.g. asthma)
    •Known HIV positivity
    •Active hepatitis B, C
    •Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of eltrombopag.
    •Subjects known or suspected of not being able to comply with a study protocol
    •Patients with recent history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the preceding 6 months
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: dose-escalation trial (4 doses of eltrombopag: 75mg, 150mg, 225mg, 300mg) to find an appropriate, feasible dose to achieve an increase in platelet count from <50.000/µ to ≥100.000/µl. An empirical, two-step escalation design with 3 to 6 patients on each dose level is used.
    Phase II: the platelet stimulation efficacy of the determined dose level will be estimated. Platelet responders are defined as achieving platelet counts ≥100.000/µl prior to cycle 1 of chemotherapy and platelet counts ≥75.000/µl in the subsequent 3 cycles (or 3 month in case of continuous chemotherapy).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: for the decision on a definite MTD at least 6 patients have to be treated on the respective dose level for 2 weeks, with a maximum of one case of dose limiting toxicity. In case of toxicity in 2 cases or more, the next lower dose is declared as MTD (or the trial terminated completely if this happens on the first dose level).
    Phase II: two stage design: The evaluation after the recruitment of 19 patients has to reveal at least 4 platelet responders to continue the trial with the recruitment of 20 additional patients. If at least 9 responders are among the 39 eltrombopag patients, treatment will be considered promising
    E.5.2Secondary end point(s)
    Comparison of:
    •adverse event/toxicity rates
    •number of bleeding events according to WHO bleeding scale
    •rate of patients with chemotherapy dose delay/reduction
    •CLL overall best response rate
    •platelets nadir
    •durations of thrombocytopenia
    •number of platelet transfusions
    •progression-free survival of CLL disease
    •duration of platelet response
    •pharmacokinetical analyses
    E.5.2.1Timepoint(s) of evaluation of this end point
    End points of trial will be evaluated whenever they occur (adverse events) as well as at patient visits during and after study treatment (follow-up).
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Combined Phase I/II study - pharmacology
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.1.7.1Other trial design description
    combined Phase I/II study (open/double blind)
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Phase I: the trial terminates completely if a non-acceptable toxicity in 2 cases or more are observed on the first dose level.
    Phase II: Within this 2-stage design the trial will be stopped althogether if treatment with eltrombopag shows no promising response after the first stage of recruiting (= first 19 eltrombopag patients). Promising response is specified with at least 4 patients with platelet responses.
    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 months6
    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 months6
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 82
    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 patients will recieve the state-of-the-art standard treatment for CLL.
    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 Decision2012-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-06
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