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    Summary
    EudraCT Number:2012-005535-90
    Sponsor's Protocol Code Number:BHS-TC-10
    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:2013-06-25
    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 number2012-005535-90
    A.3Full title of the trial
    Sequential administration of 5-azacytidine (AZA) and donor lymphocyte infusion (DLI) for patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) in relapse after allogeneic stem cell transplantation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Administration of 5-azacytidine and lymphocytes in patients in relapse after treatment by transplantation for a hematological cancer.
    A.4.1Sponsor's protocol code numberBHS-TC-10
    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 Mont-Godinne
    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 supportCelgene Europe Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCliniques Universitaires Saint-Luc
    B.5.2Functional name of contact pointPoiré Xavier
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Hippocrate, 10
    B.5.3.2Town/ cityWoluwe-Saint-Lambert
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032027641809
    B.5.6E-mailXavier.Poire@uclouvain.be
    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 Vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Lyophilisate for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    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
    Acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) in relapse after allogeneic stem cell transplantation
    E.1.1.1Medical condition in easily understood language
    Hematological cancer in relapse after transplantation
    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 10059034
    E.1.2Term Acute myeloid leukaemia recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 100000004851
    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 response rate to DLI by the combination with azacytidine in the population of patients with relapsed AML and MDS after allo-SCT.
    E.2.2Secondary objectives of the trial
    - To evaluate disease-free survival at 2 years.
    - To evaluate overall survival at 2 years.
    - To assess the toxicity profile (hematological and non-hematological).
    - To assess the incidence and severity of GvHD.
    - To assess the incidence and severity of infections.
    - To compare the study cohort to an historical group of patients with similar characteristics.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Influence of the therapy on immune reconstitution and on Treg expansion.
    E.3Principal inclusion criteria
    Patients :
    -Age ≥ 18 years.
    -Be able to understand and sign informed consent.
    -Fertile patients must use a reliable contraception method.

    Disease status at transplantation :
    -Acute myelogenous leukemia (AML) in first or subsequent complete remission (< 5% marrow blasts).
    -Myelodysplastic syndrome (MDS) with less than 10% marrow blasts at the time of transplantation.

    Transplantation :
    -Allogeneic transplantation using a sibling or unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of one allele or one antigen or 1 antigen + 1 allele or 1 antigen + 1 DQB1 antigen or 2 alleles mismatches.
    -Standard or reduced-intensity conditioning.
    -Second transplantation is allowed.
    -Donor is willing to donate lymphocytes.

    Clinical situation:
    -Cytologic relapse after allo-stem cell transplantation defined as the recurrence of more than 5% blasts on bone marrow aspiration (AML) or evidence of MDS
    -Immunophenotypic relapse defined as the recurrence of an abnormal phenotype on flow cytometry in bone marrow aspirate.
    -Cytogenetic or molecular relapse defined as the persistence or recurrence of a cytogenetic abnormality or molecular marker in bone marrow aspiration or peripheral blood. WT1 expression is not considered as reliable marker for relapse in this protocol but FLT3-ITD, NPM1, CEBPA, or translocation-specific markers (such as MLL-PTD, AML-ETO, CBFB-MYH11) are.

    Immunosuppressive therapy should have been stopped before inclusion.
    E.4Principal exclusion criteria
    -More than 30% marrow blasts at the time of inclusion.
    -Extramedullary relapse including central nervous involvement.
    -ECOG Performance status > 2.
    -Active acute grade II-IV GvHD at the time of inclusion.
    -Active chronic GvHD requiring systemic therapy at the time of inclusion.
    -Uncontrolled infection.
    -HIV positive.
    -Acute or chronic heart failure (NYHA class III or IV) or symptomatic ischemic heart disease or
    ejection fraction < 35% or uncontrolled arrhythmia.
    -Severe liver failure (total bilirubin > 3 mg/dL, SGPT > 4 X upper normal limit).
    -Severe pulmonary failure (corrected DLCo < 35%).
    -Terminal renal failure requiring dialysis.
    -Severe neurological or psychiatric disorders.
    -Concurrent investigational drug.
    -Other treatment for relapse, except for hydroxyurea but it should be stopped before inclusion in the study.
    -Female who is pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    The overall response rate to the combination of azacytidine and DLI will be defined by the addition of complete remission and partial remission.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be evaluated at day 24 of cycle 1, 3 and 5. Then every 3 months for a year after cycle 6 thereafter at 1.5 and 2 years after cycle 6.
    E.5.2Secondary end point(s)
    1. Evaluation of disease-free survival.
    2. Evaluation of overall survival.
    3. Evaluation of haematological and non-haematological toxicities and safety of the planned therapy.
    4. Incidence and severity of acute and chronic GvHD.
    5. Incidence and severity of infections.
    6. Compare the study cohort to an historical group of patients with similar characteristics.
    Sub-study
    7. Influence of the therapy on immune reconstitution.
    8. Influence of the therapy on Treg expansion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At 2 years after cycle 6.
    2. At 2 years after cycle 6.
    3. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years.
    4. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years.
    5. At the beginning of each cycle and at the discretion of the investigator until cycle 6, then monthly for 6 months, thereafter every 3 months for 1.5 years.
    6. At the end of the study.
    Sub-study
    7. On day 1 of each cycle until cycle 6, then every 3 months for a year and at 1.5 and 2 years after cycle 6.
    8. On day 1 of each cycle until cycle 6, then every 3 months for a year and at 1.5 and 2 years after cycle 6.
    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 concerned12
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    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 years9
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state50
    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 normally.
    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 Decision2013-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-22
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