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    Summary
    EudraCT Number:2007-005009-24
    Sponsor's Protocol Code Number:INO-0107
    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:2009-08-12
    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 number2007-005009-24
    A.3Full title of the trial
    An international randomised, multicentre, parallel-group, Phase III comparative study of inolimomab against usual care in the treatment of Primary Steroid Refractory Acute Graft versus Host Disease (aGvHD) following allogeneic Stem Cell Transplantation in adult patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III study in adults comparing inolimomab with standard of care in the treatment of acute graft versus host disease
    A.4.1Sponsor's protocol code numberINO-0107
    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 SponsorEUSA pharma SAS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEUSA Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEUSA Pharma
    B.5.2Functional name of contact pointPhilippe GARD
    B.5.3 Address:
    B.5.3.1Street AddressLes Jardins d'Eole, 3 allee des Sequoias
    B.5.3.2Town/ cityLimonest
    B.5.3.3Post code69760
    B.5.3.4CountryFrance
    B.5.4Telephone number33437 49 85 85
    B.5.6E-mailphilippe.gard@eusapharma.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/028
    D.3 Description of the IMP
    D.3.1Product nameLeukotac
    D.3.2Product code Inolimomab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNinolimomab
    D.3.9.1CAS number 152981-31-2
    D.3.9.2Current sponsor codeB-B10, BT 563
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    Treatment of primary steroid refractory acute Graft versus Host Disease after allogeneic haematopoietic stem cell transplantation in adult patients
    E.1.1.1Medical condition in easily understood language
    acute graft versus host disease
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10066260
    E.1.2Term Acute graft versus host disease
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Therapy success defined as overall survival at one year without replacement of the baseline allocated treatment
    E.2.2Secondary objectives of the trial
    -To determine Overall Response Rate (CR + PR) at D29
    -To evaluate duration of the response
    -To determine the effect of inolimomab and usual care on the survival rate at D100, 6 months after randomisation and 1-year post-transplant
    -To determine the effect of inolimomab and usual care on the Transplant Related Mortality and the Disease Free Survival at D100, 6 months and 1 year after randomisation
    -To determine incidence of chronic GvHD, infections (bacterial and fungal) and Post-Transplant Lymphoproliferative disease and relapse of hematological malignancy
    -To determine the patients viral status evolution (CMV and EBV reactivation and other viral infections)
    -To determine the total amount of steroids used up to 1 year post randomisation
    -To determine duration of hospital stay up to 1 year post randomisation
    -Safety profile and presence of HAMAs
    -To study pharmacokinetics of inolimimab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. age > or = 18 years
    2. first allogeneic bone marrow or peripheral Stem Cell Transplantation from HLA-matched sibling donor or 10/10 HLA unrelated donor or 9/10 HLA donor for treatment of hematological malignancy or aplastic anaemia
    3. patients can have received either a myeloablative or reduced-intensity conditioning regimen. Patients who have received a reduced-intensity conditioning regimen can be included if their first acute GvHD episode is within 6 months after the HSCT (within 100 days for the patients with standard myeloablative conditioning regimen)
    4. patients must be in Complete Remission or in chronic Phase (concerning the CML) or at least in stable disease (concerning CLL, high and low grade NHL, HL, myeloma, myeloproliferative diseases and myelodysplasia) from the underlying hematological malignancy at the time of SCT. Patients with aplastic anaemia requiring allogeneic transplantation.
    5. GvHD prophylaxis with: short regimens (D1, D3 and D6 or D1, D3, D6 and D11) of methotrexate and cyclosporine or tacrolimus OR MMF (D-1 to D28) and cyclosporine (or tacrolimus) OR MMF (D-1 to D90) in case of HLA unrelated donor OR cyclosporine (or tacrolimus) alone for patients receiving in-vivo T-cells depleted graft (with ATG) OR Sirolimus at the following dosage: Day -3: 1 dose of 6 mg (upload dose); Day -2: 1 dose of 2 mg; then dose adaptation to reach values between 5-15 ng/ml and this to day 100 for related donors and to day 180 for MUD transplants. After that a gradual reduction to 0.
    6. patient with the first episode of grade II to IV aGvHD (according to modified Glucksberg scoring system) developed within 100 days after HSCT and patients who have received a reduced-intensity conditioning regimen if their first acute GvHD episode is within 6 months after the HSCT (within 100 days for the patients with standard myeloablative conditioning regimen)
    7. patient who already received MP (2mg/kg) as treatment and must have shown a resistance as defined by one of the following items: GvHD progressing after 3 days of MP treatment OR GvHD persisting after 7 days of MP treatment OR During the decrease of corticosteroids, in case of rebound of GvHD with grade equal or greater than II and as the dose of corticosteroids is still equal or more than 1 mg/kg/D
    8. male and female patients must observe adequate birth control measures
    9. patients must give written informed consent before completing any study related procedure which means assessment or evaluation that would not form part of the normal medical practice care of the patient
    E.4Principal exclusion criteria
    1. post donor lymphocyte infusion GvHD
    2. During the decrease of corticosteroids, in case of rebound of GvHD with grade inferior to II and/or if the dose of corticosteroids is less than 1 mg/kg/D
    3. non 9/10 or 10/10 HLA- matched donor(sibling or unrelated)
    4. transplantation other than haematological malignancy
    5. cord blood transfusion
    6. patients who have received prophylactic regimens of GvHD with corticosteroids
    7. patient on mechanical ventilatory support
    8. progression of the malignancy at the time of inclusion
    9. serum creatinemia >30 mg/l
    10. patient with vasopressor treatment
    11. uncontrolled infection(s) within 72 hours prior to study entry despite adapted treatment.Neither continuation of antibiotics for a controlled infection nor prophylactic/empiric antiobiotics warrant exclusion
    12. pregnant or lactating females
    13. use of any investigational drug for the treatment of acute GvHD within 14 days prior to study entry
    14. any history of hypersensitivity/allergy to murine products and any other component of study drug
    15. positive HIV serology
    16. ECOG >3
    17. ASAT or ALAT > 10xULN
    18. Serum albumin < or = 15g/l
    19. minor patient and those incapable of giving informed consent
    E.5 End points
    E.5.1Primary end point(s)
    therapy success defined as overall survival at one year without replacement of the baseline allocated treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    E.5.2Secondary end point(s)
    survival evaluation at Day 100, 6 months, 1year; evaluation of transplant related mortality, evaluation of disease-free survival at Day100, 6 months, 1 year; assessment of response at Days 9,17,29,100; GvHD grading at Day 29, wks 5-9,Days 60,100 and 1 year; complete blood count, liver function test; evaluation of complications of HCT; evaluation of hematological malignancy

    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 9, 17, 29, 100; Weeks 5-9, 14, 18, 24, 26, 34, 42, 50, 1 year
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    standard of care
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Last patient last visit
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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.1.1.1In 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.1.2.1Number of subjects for this age range: 63
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Return to standard of care in consultation with Investigator
    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 Decision2009-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
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