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    Summary
    EudraCT Number:2010-024297-19
    Sponsor's Protocol Code Number:TJB1016P1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-01-18
    Trial 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 number2010-024297-19
    A.3Full title of the trial
    Allogeneic hematopoietic cell transplantation from HLA-matched donors after reduced-intensity conditioning: a phase II randomized study comparing 2 GVHD prophylaxis regimen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two methods for the prevention of graft-versus-host reactions after bone marrow transplantation.
    A.3.2Name or abbreviated title of the trial where available
    Comparison of Two GVHD Prophylaxis Regimens
    A.4.1Sponsor's protocol code numberTJB1016P1
    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 SponsorCHU de Liege
    B.1.3.4CountryBelgium
    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 organisation
    B.5.2Functional name of contact point
    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 Rapamune
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberImmunosuppressant, EU/1/01/171/009-010
    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 RoleComparator
    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 CELLCEPT
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberImmunosuppressant, EU/1/96/005
    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
    Hematologic malignancies treated by reduced-intensity conditioning allogeneic transplants.
    E.1.1.1Medical condition in easily understood language
    Patients with cancer of the blood, bone marrow or lymph nodes treated with a low dose of chimiotherapy before bone marrow transplantation from a genetic similar donor.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10001756
    E.1.2Term Allogenic bone marrow transplantation therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10018799
    E.1.2Term GVHD
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The present project aims at comparing two postgrafting immunosuppressive regimens (Tac+MMF vs Tac+Sirolimus) after Flu-TBI or Flu-Bu-ATG. The hypothesis is that the Tac+Sirolimus regimen will be associated with better progression-free survival (due to a lower incidence of relapse/progression).To compare for 1-year progression-free survival between the 2 arms in the whole group of patients and separately in those conditioned with Flu-TBI or Flu-Bu-ATG.
    Following the interim analysis of October 2014, the protocol has been amended to allow inclusion only after Flu-TBI conditioning since November the 3rd, 2014.
    E.2.2Secondary objectives of the trial
    Comparing
    1.relapse rate, nonrelapse mortality, and OS in the 2 arms 1, 2 and 5 years after HSCT in all the patients and separately in those conditioned with Flu-TBI or Flu-Bu-ATG.
    2.PFS in the 2 arms 2 and 5 years after HSCT, in all the patients and separately in those with Flu-TBI or Flu-Bu-ATG.
    3.hematopoietic engraftment; evaluation 1-year of graft rejection in the 2 arms, in all the patients and separately in those with Flu-TBI or Flu-Bu-ATG.
    4.6-mo of grades II-IV and III-IV acute GVHD in the 2 arms, in all the patients and separately in those with Flu-TBI or Flu-Bu-ATG.
    5.1-yr of chronic GVHD in the 2 arms, in all the patients and separately in those with Flu-TBI or Flu-Bu-ATG.
    6.quality and timing of immunologic reconstitution in the 2 arms, in all the patients and separately in those with Flu-TBI or Flu-Bu-ATG.
    7.1-yr infections in the 2 arms, in all the patients and separately in those with Flu-TBI or Flu-Bu-ATG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Hematological malignancies confirmed histologically and not rapidly progressing:
    - AML in CR (defined as ≤ 5% marrow blasts and absence of blasts in the peripheral blood);
    - MDS with ≤ 5% marrow blasts and absence of blasts in the peripheral blood;
    - CML in CP;
    - MPS not in blast crisis and not with extensive marrow fibrosis,
    - ALL in CR;
    - Multiple myeloma not rapidly progressing;
    - CLL;
    - Non-Hodgkin’s lymphoma (aggressive NHL should have chemosensitive disease);
    - Hodgkin’s disease with chemosensitive disease.
    Clinical situations:
    •Theoretical indication for a standard allo-transplant, but not feasible because:
    - Age > 50 yrs;
    - Unacceptable end organ performance;
    - At the physician’s decision;
    - Patient’s refusal.
    •Indication for a standard auto-transplant:
    -perform mini-allotransplantation 2-6 months after standard autotransplant.

    •Other inclusion criteria
    -Male or female; fertile patients must use a reliable contraception method;
    -Age ≤75 yrs (children of any age are allowed in the protocol);
    -Informed consent given by patient or his/her guardian if of minor age.

    E.4Principal exclusion criteria
    •Any condition not fulfilling inclusion criteria;
    •HIV positive;
    •Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT;
    •Life expectancy severely limited by disease other than malignancy;
    •Administration of cytotoxic agent(s) for “cytoreduction” within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);
    •CNS involvement with disease refractory to intrathecal chemotherapy.
    •Terminal organ failure, except for renal failure (dialysis acceptable)
    -a.Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction <35%; uncontrolled arrhythmia, uncontrolled hypertension;
    -b.Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen;
    -c.Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL, and symptomatic biliary disease;
    •Uncontrolled infection;
    •Karnofsky Performance Score <70%;
    •Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;
    •Patient is a female who is pregnant or breastfeeding;
    •Any condition precluding the use of sirolimus or MMF.

    E.5 End points
    E.5.1Primary end point(s)
    Comparing the 1-year progression-free survival between the Tracolimus plus Mycophenolate Mofetil arm and the Tracolimus plus Sirolimus arm in the whole group of patients and separately in those conditioned with Flu-TBI or Flu-Bu-ATG before grafting.
    E.5.1.1Timepoint(s) of evaluation of this end point
    100 and 180 days post-engraftment.
    The evaluation will continue the 2, 3, 4 and 5 year after post-engraftment.
    E.5.2Secondary end point(s)
    All the following comparisons will be done in the 2 arms, in the whole group of patients and separately in those conditioned with Flu-TBI or Flu-Bu-ATG:
    1-Comparing relapse rate, nonrelapse mortality, and overall survival 1, 2 and 5 years after HSCT.
    2-Comparing progression-free survival 2 and 5 years after HSCT.
    3-Comparing hematopoietic (whole blood and T cell chimerism) engraftment and to evaluate the 1-year incidence of graft rejection.
    4-Comparing the 6-mo incidence of grades II-IV and III-IV acute GVHD.
    5-Comparing the 1-yr incidence of chronic GVHD..
    6-Comparing the quality and timing of immunologic reconstitution.
    7- Comparing the 1-yr incidences of bacterial, fungal and viral infections.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of engraftment:
    a) peripheral blood :
    -Days 28, 42, 60, 100, 180 and 365 post-transplant : whole blood and CD3+ cells.
    b) whole bone marrow :
    -Days 42, 100, 180 and 365 post-transplant.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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
    Mycophenolate mofetil
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Five years after the last patient will be included in the trial and be transplanted
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    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.1.3Elderly (>=65 years) Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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 Decision2011-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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