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    Summary
    EudraCT Number:2016-002129-12
    Sponsor's Protocol Code Number:P150955
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002129-12
    A.3Full title of the trial
    A randomized phase IIb study of cyclophosphamide (Cy) versus anti-thymocyte globulin (ATG) for the prophylaxis of graft-versus-host disease (GVHD) after reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation
    Etude randomisée de phase IIb comparant cyclophosphamide et sérum anti-lymphocytaire (ATG) pour la prophylaxie de la maladie du greffon contre l'hôte (GVHD) après allogreffe de cellules souches de sang périphérique avec conditionnement d'intensité réduite
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Graft-versus-host response after reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation
    Réaction du greffon contre l'hôte après allogreffe de cellules souches de sang périphérique avec conditionnement d'intensité réduite
    A.3.2Name or abbreviated title of the trial where available
    ATG-CY GVHD
    A.4.1Sponsor's protocol code numberP150955
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailmaud.jacubert@aphp.fr
    D. IMP Identification
    D.IMP: 1
    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 Thymoglobuline
    D.2.1.1.2Name of the Marketing Authorisation holderGENZYME EUROPE B.V
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameThymoglobuline
    D.3.4Pharmaceutical form Powder for 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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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 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 Cyclophosphamide
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCyclophosphamide
    D.3.4Pharmaceutical form Powder for 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 INNCyclophosphamide
    D.3.9.3Other descriptive nameCyclophosphamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    Women and men with a hematologic malignancy for which a reduced-intensity conditioning allo-SCT is indicated
    Femmes et hommes ayant une pathologie hématologique maligne pour lesquels une allogreffe avec conditionnement à intensité réduite est indiquée.
    E.1.1.1Medical condition in easily understood language
    hematologic malignancy pathology
    Pathologie hématologique maligne
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10053239
    E.1.2Term Prophylaxis against graft versus host disease
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare at 12 months the efficacy of post-transplant cyclophosphamide (PTCy) versus anti-thymocyte globulin (ATG) for GVHD prophylaxis in the setting of Fludarabine-Busulfan reduced-intensity conditioning (RIC) as determined by a composite endpoint of GVHD-free, relapse-free survival (GRFS) allogeneic peripheral blood stem cell transplantation.
    Comparer à 12 mois l'efficacité post-transplantation du cyclophosphamide versus sérum anti-lymphocitaire (ATG) pour la prophylaxie de GVHD avec conditionnement d'intensité réduite par busulfan et fludarabine IV défini par un critère composite de la survie sans GVHD et sans rechute après allogreffe de cellules souches périphériques.
    E.2.2Secondary objectives of the trial
    o To evaluate the occurrence of grade 2-4 and grade 3-4 severe acute GVHD, according to the Glucksberg criteria revised by Przepiorka et al., within the first 6 months after transplantation.
    o To evaluate the occurrence of chronic GVHD as assessed by NIH Consensus Criteria within the first 12 months after transplantation.
    o To evaluate non-relapse mortality within the first 12 months after transplantation.
    o To evaluate disease-free and overall survival at 12 months after transplantation.
    o To evaluate the Quality of Life (QoL) in both treatment arms.
    o Descriptive immune recovery studies (lymphocytes -including regulatory cells- and dendritic cells subsets) related to the use of PTCy versus ATG in GVHD prophylaxis.
    o Evaluer la survenue des grades 2-4 et grade 3-4 de GVHD aigüe sévère dans les 6 premiers mois après la greffe.
    o Evaluer la survenue de GVHD chronique dans les 12 premiers mois après la greffe
    o Evaluer la mortalité non liée à la rechute dans les 12 premiers mois après la greffe
    o Evaluer la survie sans rechute la survie globale 12 mois après la greffe
    o Evaluer la qualité de vie dans les deux bras de traitement
    o Améliorer les connaissances du mécanisme d'action du PTCy et du sérum anti-lymphocytaire (SAL) dans la prophylaxie de la maladie du greffon contre l'hôte avec des études descriptives de récupération immunitaire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged between 18 and 65 years
    - Presence of a hematologic malignancy for which a reduced-intensity conditioning allo-SCT is indicated (eligibility criteria for RIC allo-SCT include at least one of the following parameters: (i) patient age older than 50 years; (ii) heavily pre-treated patients who received an autologous hematopoietic SCT (auto-SCT) or with more than 2 lines of chemotherapy before allo-SCT ; and (iii) patients with poor performance status because of significant medical comorbidities as described by Sorror et al.
    - Karnofsky index ? 70%
    - Availability of a sibling or unrelated stem-cell donor (10/10-HLA matched unrelated donor)
    - Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment
    - Written informed consent.
    - Affiliation to a social security system (recipient or assign)
    - Patients âgés de 18 à 65 ans
    - Présence d'une pathologie hématologique maligne pour laquelle une allogreffe de cellules souches hématopoïétiques (allo-CSH) avec conditionnement d'intensité réduite (RIC) est indiquée (critères d'éligibilité pour allo-CSH RIC) incluant au moins l'un des paramètres suivants :
    (i) patient âgé de plus de 50 ans
    (ii) patients ayant déjà été lourdement traité et qui ont reçu une auto-CSH ou ayant reçu plus de 2 lignes de chimiothérapie avant allo-CSH
    (iii) patients ayant un PS faible à cause d'une comorbidités médicalement significative comme décrite par Sorror et al.
    - Index de Karnofsky ? 70%
    - Disponiblité d'un parent compatible ou d'un donneur non apparenté (compatibilité HLA 10/10)
    - Méthode de contraception efficace au moins 1 mois pour les femmes et 3 mois pour les hommes après la dernière dose de traitement
    - Consentement éclairé écrit
    - Affiliation à un système de sécurité sociale (affilié ou ayant droit)
    E.4Principal exclusion criteria
    - Creatinine clearance less than 30 mL/min
    - Bilirubin or amino-transferases above 3X upper normal limit
    - Cardiac ejection fraction less than 40%
    - Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)
    - Known hypersensitivity or contraindication to the use of post-transplant Cy and ATG
    - Any circumstance that precludes the use of the drugs involved in the protocol
    - Pregnancy or breast-feeding women
    - Clairance de la créatinine inférieure à 30 mL/min
    - Bilirubine ou aminotransférase au-dessus de 3 fois la limite normale supérieure
    - Fraction d'éjection cardiaque inférieure à 40%
    - Insuffisance pulmonaire avec DLCO (capacité de diffusion pulmonaire par le monoxyde de carbone) < 50%
    - Hypersensibilité connue ou contre-indication à l'utilisation post-greffe de Cy et/ou de SAL
    - Toute circonstance qui empêche l'utilisation d'un des médicaments impliqués dans le protocole
    - Femme enceinte ou allaitante
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial will be the assessment of a composite endpoint of graft-versus-host disease-free, relapse-free survival (GRFS) at 12 months after allogeneic stem cell transplantation.
    Le critère de jugement principal de l'étude est l'évaluation d'un critère composite de la survie sans GVHD et sans rechute (GRFS) à 12 mois d'une allogreffe de cellules souches.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    o Cumulative incidence of grade 2-4 and grade 3-4 severe acute GVHD, according to the Glucksberg criteria revised by Przepiorka et al., within the first 6 months after transplantation.
    o Cumulative incidence of chronic GVHD as assessed by NIH Consensus Criteria within the first 12 months after transplantation.
    o Cumulative incidence of non-relapse mortality within the first 12 months after transplantation.
    o Disease-free and overall survival at 12 months after transplantation.
    o Quality of Life (QoL) in both treatment arms at D-7,D30, D90, D180 and D360.
    o Descriptive immune recovery studies (lymphocytes -including regulatory cells- and dendritic cells subsets) related to the use of PTCy versus ATG in GVHD prophylaxis.
    o L'incidence cumulée de GVH aigue de grades 2-4 et de grades 3-4, d'après les critères de Glucksberg révisés par Przepiorka et al., dans les 6 mois suivant la greffe
    o L'incidence cumulée de GVH chronique selon les critères définis par le consensus NIH dans les 12 premiers mois suivants la greffe
    o L'incidence cumulée de la mortalité non liée à la rechute dans les 12 premiers mois suivants la greffe
    o L'absence de rechute et la survie globale 12 mois après la greffe
    o La qualité de vie dans les 2 bras de traitements à J-7, J30, J180 et J360
    o Etudes descriptives de la récupération immunitaire (lymphocyte - y compris cellules régulatrices - et cellules dendritiques) après utilisation de cyclophosphamide (PTCy) versus sérum anti-lymphocytaire (SAL) pour la prophylaxie de la maladie du greffon contre l'hôte.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 6 et 12 months
    1, 3, 6 et 12 mois
    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 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase IIb
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned7
    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 years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned 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: 88
    F.1.3Elderly (>=65 years) No
    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 state88
    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)
    None
    Aucun
    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 Decision2016-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-12
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