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    The EU Clinical Trials Register currently displays   37995   clinical trials with a EudraCT protocol, of which   6234   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:2013-003369-33
    Sponsor's Protocol Code Number:Uni-Koeln-1698
    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:2015-07-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-003369-33
    A.3Full title of the trial
    JeRiCHO (JAK-inhibition in recurrent classical Hodgkin Lymphoma): A phase II, open-label, prospective, non-randomized, multicenter clinical trial with the JAK-inhibitor ruxolitinib in patients with relapsed or refractory Hodgkin Lymphoma (HL).
    JeRiCHO (JAK-inhibition in recurrent classical Hodgkin Lymphoma): Eine Phase II, unverblindete, prospektive, nichtrandomisierte, multizentrische klinische Studie mit dem JAK-Inhibitor Ruxolitinib für Patienten mit rezidiviertem oder refraktärem Hodgkin Lymphom (HL).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    JeRiCHO: A study to improve the treatment of relapsed or refractory Hodgkin Lymphoma with JAK-inhibitor (Ruxolitinib).
    JeRiCHO: EIne Studie zur Verbesserung der Behandlung von rezidivierten oder refraktären Hodgkin Lymphom Patienten mit dem JAK-Inhibitor (Ruxolitinib).
    A.3.2Name or abbreviated title of the trial where available
    JeRiCHO (JAK-inhbition in recurrent classical Hodgkin Lymphoma)
    JeRiCHO (JAK-Inhibiton bei rezidiviertem Hodgkin Lymphom)
    A.4.1Sponsor's protocol code numberUni-Koeln-1698
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02164500
    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 cologne
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGerman Hodgkin Study Group
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGleueler Straße 269-273
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50935
    B.5.3.4CountryGermany
    B.5.4Telephone number004922147888200
    B.5.5Fax number004922147888188
    B.5.6E-mailghsg@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 Yes
    D.2.1.1.1Trade name Jakavi 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRuxolitinib
    D.3.4Pharmaceutical form 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 INNRuxolitinib
    D.3.9.1CAS number 1092939-17-7
    D.3.9.3Other descriptive nameRUXOLITINIB PHOSPHATE
    D.3.9.4EV Substance CodeSUB32897
    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
    relapsed or refractory
    Hodgkin Lymphoma
    rezidiviertes oder refraktäres Hodgkin Lymphom
    E.1.1.1Medical condition in easily understood language
    reappearance of Hodgkin Lymphoma that did not respond to therapy
    Rückfall eines Hodgkin Lymphoms oder Hodgkin Lymphom, das auf Therapie nicht ansprach
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 determine the overall response rate (ORR, complete response [CR] + partial response [PR]) in patients with relapsed or refractory HL
    E.2.2Secondary objectives of the trial
    • To determine the safety profile of ruxolitinib in patients with relapsed or refractory HL
    • To estimate progression-free survival (PFS) and overall survival (OS)
    • To explore biomarkers predictive of response to ruxolitinib
    • To assess quality of life (QoL) before and during treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with relapsed or refractory HL after any polychemotherapy regimen including HDCT and ASCT who are not eligible for (another) HDCT and ASCT; age: 18 to 99 years; ECOG ≤ 2, no major organ dysfunction (except HL related), written informed consent; Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L, platelets ≥ 100 x 109/L; Total bilirubin ≤ 2 x ULN (if >2 x ULN direct bilirubin is required and should be ≤1.5 x ULN); ASAT ≤ 3 x ULN (≤ 5 x ULN if liver involvement is present); serum creatinine ≤ 2 x ULN; ≥2 weeks since last tumor therapy
    E.4Principal exclusion criteria
    Patients who have a history of another primary malignancy ≤ 2 years; Female patients who are pregnant or breast feeding; Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study drug start; Patients with a known history of HIV seropositivity, chronic active hepatitis
    E.5 End points
    E.5.1Primary end point(s)
    • ORR after two cycles (based on PET-CT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After two cycles
    E.5.2Secondary end point(s)
    • Adverse events during therapy
    • ORR after two cycles (based on CT only)
    • Treatment administration (dose reductions, duration of treatment)
    • Progression free survival (PFS)
    • Overall Survival (OS)
    • Best response during therapy (based on PET-CT)
    • Exploratory description of biomarkers
    • QoL before therapy and at the restaging after two cycles
    E.5.2.1Timepoint(s) of evaluation of this end point
    During an directly after therapy.
    Restagings are performed every three months.
    All patients will be followed for 12 months after off-treatment visit.
    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.8.2.4Number of treatment arms in the trial1
    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 concerned5
    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
    Remission status of all patients achieving at least SD will be followed for 12 months after off-treatment visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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 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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state37
    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)
    Treatment after discontinuation of the study drug will be continued according to local standards.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation German Hodgkin Study Group
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-30
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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