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    Summary
    EudraCT Number:2013-005508-33
    Sponsor's Protocol Code Number:MC-FludT.16/NM
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-05-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005508-33
    A.3Full title of the trial
    Clinical phase II trial to compare Treosulfan-based conditioning therapy with Busulfan-based conditioning prior to allogeneic haematopoietic stem cell transplantation (HSCT) in paediatric patients with
    non-malignant diseases
    Klinische Phase II Prüfung zum Vergleich einer Treosulfan-basierten mit einer Busulfan-basierten Konditionierungstherapie vor allogener Stammzelltransplantation (SZT) in pädiatrischen Patienten mit nicht-bösartigen Erkrankungen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Treosulfan-based with Busulfan-based conditioning in paediatric patients with non-malignant diseases
    Vergleich einer Treosulfan-basierten mit einer Busulfan-basierten Konditionierung bei pädiatrischen Patienten mit nicht-bösartigen Erkrankungen
    A.3.2Name or abbreviated title of the trial where available
    Treosulfan-based versus Busulfan-based conditioning in paediatric patients with non-malignant diseas
    Treosulfan-basierte versus Busulfan-basierte Konditionierung in pädiatrischen Patienten mit nicht-bö
    A.4.1Sponsor's protocol code numberMC-FludT.16/NM
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/033/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsormedac GmbH
    B.1.3.4CountryGermany
    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 supportmedac GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationmedac GmbH
    B.5.2Functional name of contact pointDr Jochen Kehne
    B.5.3 Address:
    B.5.3.1Street AddressTheaterstrasse 6
    B.5.3.2Town/ cityWedel
    B.5.3.3Post code22880
    B.5.3.4CountryGermany
    B.5.4Telephone number004941038006388
    B.5.5Fax number004941038006422
    B.5.6E-mailj.kehne@medac.de
    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 Ovastat 1000 (Treosulfan injection)
    D.2.1.1.2Name of the Marketing Authorisation holdermedac GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/3/04/186
    D.3 Description of the IMP
    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 INNTREOSULFAN
    D.3.9.1CAS number 299-75-2
    D.3.9.4EV Substance CodeSUB11235MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.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 Ovastat 5000 (Treosulfan injection)
    D.2.1.1.2Name of the Marketing Authorisation holdermedac GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/3/04/186
    D.3 Description of the IMP
    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 INNTREOSULFAN
    D.3.9.1CAS number 299-75-2
    D.3.9.4EV Substance CodeSUB11235MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    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.IMP: 3
    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 Busilvex
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Medicament
    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/3/00/011
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate 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 INNBUSULFAN
    D.3.9.1CAS number 55-98-1
    D.3.9.4EV Substance CodeSUB05993MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    Male and female children with non-malignant diseases requiring myeloablative conditioning treatment with following allogeneic haematopoietic stem cell transplantation (allo-HSCT) – i.e. primary immunodeficiencies, inborn errors of metabolism, haemoglobinopathies and bone marrow failure syndromes.
    Kinder, männlichen und weiblichen Geschlechts, mit nicht-bösartigen Erkrankungen, die eine myeloablative Konditionierungstherapie mit anschließender allogener hämatopoetischer Stammzelltransplantation (allo-HSZT) benötigen - primäre Immundefekte, Stoffwechselerkrankungen, Hämoglobinopathien und Knochenmarkversagen.
    E.1.1.1Medical condition in easily understood language
    Children with non-malignant diseases requiring conditioning treatment prior to stem cell transplantation
    Kinder mit nicht-bösartigen Erkrankungen, die eine Konditonierungsbehandlung vor Stammzelltransplantation benötigen
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10021606
    E.1.2Term Inborn errors of metabolism NEC
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10036700
    E.1.2Term Primary immunodeficiency syndromes
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10018903
    E.1.2Term Haemoglobinopathies congenital
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparative evaluation of freedom from transplant (treatment)-related mortality (TRM), defined as death from any transplant-related cause from the day of first administration of study medication (day -7) until day +100 after HSCT.
    E.2.2Secondary objectives of the trial
    1. Comparative evaluation of neutropihil and platelet engraftment after HSCT.
    2. Comparative evaluation of safety including early toxicity until day +100 after HSCT, SARs until the end of longer-term follow-up phase.
    3. Comparative evaluation of HSOS, lung toxicity, hepatic toxicity and infections of any CTCAE grade until day +100.
    4. Comparative evaluation of chimerism on day +28, day +100 and 12 months after HSCT.
    5. Comparative evaluation of OS until 12 months after HSCT.
    6. Comparative evaluation of graft failure until 12 months after HSCT.
    7. Comparative evaluation of acute (until day +100) and chronic (until 12 months after HSCT) GvHD.
    8. Comparative evaluation of use of rescue therapies including DLIs and further conditioning regimens.
    9. Evaluation of PK parameters of Treosulfan and its epoxides and to develop a PK model for assessing relevant covariates.
    10. Comparative evaluation of graft failure, cGvHD, OS and TRM during the longer-term follow-up phase.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Non-malignant disease indicated for first myeloablative allogeneic HSCT, including inborn errors of metabolism, primary immunodeficiencies, haemoglobinopathies and bone marrow failure syndromes.
    2. First allogeneic HSCT.
    3. Available matched sibling donor (MSD), matched family donor (MFD) or matched unrelated donor (MUD). For bone marrow (BM) and peripheral blood (PB) match is defined as at least 9/10 allele matches after four digit typing in human leucocyte antigen (HLA)-A, -B, -C, –DRB1 and DQB1 antigens. For umbilical cord blood (UCB) match is defined as at least 5/6 matches after two digit typing in HLA-A and -B and four digit typing in DRB1 antigens.
    4. Age at time of registration from 28 days to less than 18 years of age.
    5. Lansky (patients <16 years of age) or Karnofsky (patients ≥ 16 years of age) performance score of at least 70%.
    6. Written informed consent of the parents/legal guardians and patient’s assent/consent according to national regulations.
    7. Female patients of child-bearing potential or partner of male patients with child-bearing potential must use a highly effective method of contraception (pearl index < 1%) such as complete sexual abstinence, combined oral contraceptive, hormone intrauterine contraceptive device (IUCD), vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients or male partners during the study and at least six months thereafter.
    8. Negative pregnancy test for females of child-bearing potential.
    E.4Principal exclusion criteria
    1. Second or later HSCT.
    2. HSCT from mismatched donor (less than 9/10 BM/peripheral blood stem cells (PBSC) or less than 5/6 matched cord donor).
    3. Preterm newborn infants (<37 weeks gestational age) and term newborn infants aged 0 – 27 days at time of registration.
    4. Obese paediatric patients with body mass index weight (kg)/[height (m)]² > 30 kg/m².
    5. Diagnosis of Fanconi anaemia and other chromosomal breakage disorders, radiosensitivity disorders (deoxyribonucleic acid (DNA) Ligase 4, Cernunnos- X-ray repair cross-complementing protein 4 (XRCC4) like factor (XLF), Nijmegen Breakage Syndrome (NBS)) and Dyskeratosis Congenita.
    6. Treatment with cytotoxic drugs within 10 days prior to day 7.
    7. Impaired liver function indicated by Bilirubin > three times the upper limit of normal (ULN) or aspartate aminotransferase/alanine aminotransferase (AST/GOT, ALT/GPT) > five times ULN or active infectious hepatitis.
    8. Impaired renal function indicated by estimated glomerular filtration rate ([GFR], according to the Schwartz formula) < 60 mL/min/1.73m2.
    9. Impaired cardiac function: severe cardiac insufficiency indicated by left ventricular ejection fraction (LVEF)  35%.
    10. Requirement for supplementary continuous oxygen.
    11. Severe active infection requiring deferral of conditioning.
    12. Human immunodeficiency virus (HIV) positivity.
    13. Severe concomitant illness, comorbidity or condition that would severely limit life expectancy.
    14. Known pregnancy, breast feeding.
    15. Known hypersensitivity to Treosulfan, Busulfan, Fludarabine and/or Thiotepa.
    16. Participation in another interventional clinical study with an experimental drug, within four weeks prior to patient inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Comparative evaluation of freedom from transplant (treatment)-related mortality (TRM), defined as death from any transplant-related cause from the day of first administration of study medication (day -7) until day +100 after HSCT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day +100 after HSCT
    E.5.2Secondary end point(s)
    1. Comparative evaluation of engraftment after HSCT, defined as the first of three consecutive days for each of the following four criteria:
    - a leukocyte count of more than 1 x 109/L
    - an absolute neutrophil count (ANC) of more than
    0.5 x109/L
    - a platelet count of at least 20 x109/L
    - a platelet count of at least 50 x109/L.
    2. Comparative evaluation of safety including early toxicity, based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 until day +100 after HSCT, serious adverse reactions (SARs) until the end of longer-term follow-up phase (three years after HSCT of last patient).
    3. Comparative evaluation of hepatic sinusoidal obstruction syndrome (HSOS), lung toxicity (CTCAE term pulmonary fibrosis), hepatic toxicity (according Bearman’s criteria) and infections of any CTCAE grade (non-serious and serious) until day +100.
    4. Comparative evaluation of donor-type chimerism on day +28, day +100 and 12 months after HSCT.
    5. Comparative evaluation of overall survival (OS) until 12 months after HSCT.
    6. Comparative evaluation of primary and secondary graft failure until 12 months after HSCT.
    7. Comparative evaluation of incidence and severity of acute (until day +100) and chronic (until 12 months after HSCT) graft versus host disease (aGvHD/cGvHD).
    8. Comparative evaluation of use of rescue therapies including donor-lymphocyte infusions (DLIs) and further conditioning regimens.
    9. Evaluation of PK parameters of Treosulfan and its epoxides and to develop a PK model for assessing relevant covariates.
    10. Comparative evaluation of secondary graft failure, cGvHD, OS and TRM during the longer-term follow-up phase.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day +28, day +100 and 12 months after HSCT and/or until the end of the longer-term follow-ip phase.
    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 Yes
    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 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 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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Subsequent to the 12-months follow-up, all patients will be followed on a yearly basis for a minimum of two additional years. This longer-term follow-up phase is scheduled until three years after HSCT of the last patient enrolled into the study. The end of the trial is defined as last follow-up visit of last subject.
    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 months6
    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 months3
    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 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children below 18 years of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    After study participation, patients will receive treatment/medical care as routinely used in medical conditions after conditining treatment and subsequent allogeneic stem cell transplantation.
    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 Decision2015-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
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