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    Summary
    EudraCT Number:2012-004246-15
    Sponsor's Protocol Code Number:HIJAK
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-004246-15
    A.3Full title of the trial
    A Phase II study of oral JAK1/JAK2 inhibitor INC424 in adult patients with relapsed/refractory classical Hodgkin’s lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to obtain preliminary efficacy data of oral JAK1/JAK2 inhibitor INC424 in adult patients with relapsed/refractory classical Hodgkin’s lymphoma
    A.4.1Sponsor's protocol code numberHIJAK
    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 SponsorLYSARC
    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 supportNOVARTIS PHARMA S.A.S
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointElise Hutasse - Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressCentre Hospitalier Lyon Sud - Secteur Sainte Eugénie - Pavillon 6D
    B.5.3.2Town/ cityPierre Bénite Cedex
    B.5.3.3Post codeF-69495
    B.5.3.4CountryFrance
    B.5.4Telephone number33472669333
    B.5.5Fax number33426074055
    B.5.6E-mailelise.hutasse@lysarc.org
    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
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/572
    D.3 Description of the IMP
    D.3.1Product nameruxolitinib
    D.3.2Product code INC424
    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.3.9.2Current sponsor codeINC424
    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 classical Hodgkin's lymphoma
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory classical Hodgkin's lymphoma
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 100000013069
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib measured by overall response rate (ORR) by IWG criteria (Cheson 2007) occurring after 6 months of oral JAK1/2 inhibitor ruxolitinib treatment in patients with advanced HL for whom no treatment with proven efficacy is available
    E.2.2Secondary objectives of the trial
    - To assess the safety of oral JAK1/2 inhibitor ruxolitinib treatment in Hodgkin Lymphoma
    - To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib measured by overall response rate (ORR) by IWG criteria (Cheson 2007) occurring after 2 and 4 cycles of oral JAK1/2 inhibitor ruxolitinib treatment
    - To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib measured by overall response rate (ORR) by IWG criteria (Cheson 1999) occurring after 2, 4 and 6 cycles of oral JAK1/2 inhibitor ruxolitinib treatment
    - To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib measured by the time to response, the duration of response, progression free survival rates after 6 and 12 months, overall survival according to IWG criteria (Cheson 1999)
    - To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib on systemic symptoms such as fever, sweating, fatigue, itching
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    anatomophatological study on tumoral biopsies :
    - FISH: JAK2 copies and rearrangements
    - Immunohistochemistry: JAK2 overexpression
    E.3Principal inclusion criteria
    - Patients ≥ 18 years with classical HL relapsing or refractory after at least 1 prior systemic therapy. Patients must have relapsed after high-dose therapy with ASCT, or have been deemed ineligible for high-dose therapy with ASCT
    - ECOG performance status < 3
    - Measurable nodal disease: 1 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan cannot be performed).
    - Patient has the following laboratory values:
    • Absolute neutrophil count (ANC) ≥ 1.0 x 109/L [SI units 1.0 x 109/L]
    • Platelet count ≥ 75 x 109/L
    • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    • Serum bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome)
    • AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN or ≤ 5.0 x ULN if the transaminase elevation is due to liver disease involvement
    - Signed written informed consent
    - Life expectancy ≥ 3 months
    - Corrected QT interval < 450 mSec
    - Men and women of childbearing potential must agree to use an adequate method of contraception during the study treatment and for at least 1 week after the last study drug administration
    - The patient must be covered by a social security system (for inclusions in France)
    E.4Principal exclusion criteria
    - Previous treatment with ruxolitinib or another JAK inhibitor
    - Contraindication to ruxolitinib
    - Patient received chemotherapy or radiotherapy or any investigational drug within 14 days prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1
    - Patient treated with allogeneic hematopoietic stem cell transplant who is currently on, or has received immunosuppressive therapy within 90 days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD).
    - Patient with prior history of another active primary malignancy ≤ 2 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
    - Any serious active disease or co-morbid medical condition that, according to the investigator’s decision, will substantially increase the risk associated with the subject’s participation in the study.
    - Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody.
    - HIV, HCV or HTLV serology positivity and/or documented infection with active hepatitis B
    - Prior history of CNS involvement with lymphoma
    - Pregnant or lactating woman
    - Adult patient unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is to assess the efficacy of oral JAK1/2 inhibitor by measuring the Overall Response Rate using the IWG criteria (International Workshop to Standardize Response criteria for NHL, Cheson 2007).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessment of response will be done after 6 cycles of treatment.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints will assess:
    • the Overall Response Rate (ORR) at 6 cycles according to Cheson 1999
    • Complete Response Rate at 2,4 and 6 cycles according to Cheson 2007
    • Complete Response Rate at 2,4 and 6 cycles according to Cheson 1999
    • Best Response Rate at 6 cycles according to Cheson 2007
    • Best Response Rate at 6 cycles according to Cheson 1999
    • Time to response
    • Duration of response
    • Progression Free Survival (PFS)
    • Overall Survival (OS)
    • Evaluation of systemic symptoms (sweating, fever, pruritus/itching, fatigue)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • the ORR at 6 cycles
    • Complete Response Rate at 2,4 and 6 cycles
    • Complete Response Rate at 2,4 and 6 cycles
    • Best Response Rate at 6 cycles
    • Best Response Rate at 6 cycles
    • Time to response will be assessed from randomization into the study to the time of attainment of PR or CR according to IWG criteria 2007
    • Duration of response will be measured from the time of attainment of CR or PR according to IWG criteria 2007 (Cheson 2007)
    • Progression Free Survival (PFS) will be measured from randomization into the study to the first observation of disease progression/relapse
    • Overall Survival (OS) will be measured from randomization into the study to the date of death from any cause
    • Evaluation of systemic symptoms (sweating, fever, pruritus/itching, fatigue) at each cycle
    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 No
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 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
    The end of the trial is defined as the last visit of the last subject of the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 33
    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)
    Patients will be treated according to local practice
    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 LYSA (The Lymphoma Study Association)
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-12
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