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    Summary
    EudraCT Number:2014-005210-28
    Sponsor's Protocol Code Number:MMM02Study
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-23
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-005210-28
    A.3Full title of the trial
    Ruxolitinib versus allogeneic stem cell transplantation for patients with myelofibrosis according to donor availability: A prospective phase II trial (MMM 02 study)
    Ruxolitinib Behandlung versus allogene Stammzelltransplantation bei Patienten mit Myelofibrose in Abhängigkeit von der Spenderverfügbarkeit
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ruxolitinib versus allogeneic stem cell transplantation for patients with myelofibrosis according to donor availability: A prospective phase II trial
    Ruxolitinib Behandlung versus allogene Stammzelltransplantation bei Patienten mit Myelofibrose in Abhängigkeit von der Spenderverfügbarkeit
    A.3.2Name or abbreviated title of the trial where available
    Ruxolitinib versus allogeneic stem cell transplantation
    Ruxolitinib Behandlung versus allogene Stammzelltransplantation
    A.4.1Sponsor's protocol code numberMMM02Study
    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 SponsorUniversity Medical Center Hamburg-Eppendorf
    B.1.3.4CountryGermany
    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 supportUniversity Medical Center Hamburg-Eppendorf
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Hamburg-Eppendorf
    B.5.2Functional name of contact pointNicolaus Kröger
    B.5.3 Address:
    B.5.3.1Street AddressMartinistrasse 52
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number0049040741054851
    B.5.5Fax number0049040741053795
    B.5.6E-mailn.kroeger@uke.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 No
    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 nameallogeneic HSC
    D.3.2Product code allogeneic HSC
    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 INNAllogene HSC
    D.3.9.3Other descriptive nameAllogene HSC
    D.3.10 Strength
    D.3.10.1Concentration unit log10/ml log10/ml
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number6 to 10
    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 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 Jakavi
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNruxolitinib
    D.3.9.1CAS number 1092939-17-7
    D.3.9.3Other descriptive nameRUXOLITINIB PHOSPHATE
    D.3.9.4EV Substance CodeSUB32897
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to 20
    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
    primary myelofibrosis
    primäre Myelofibrose
    E.1.1.1Medical condition in easily understood language
    progressive bone marrow disease (bone marrow cancer)
    fortschreitende Erkranung des Knochenmarks (Knochenmarkkrebs)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028537
    E.1.2Term Myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 efficacy in terms of event free survival of allogeneic SCT for patients with myelofibrosis who have a suitable stem cell donor after a 3 months Ruxolitinib induction therapy with patients who lack a suitable stem cell donor and will continue to receive Ruxolitinib
    Wirksamkeitsvergleich hinsichtlich eines ereignisfreien Überlebens einer allogenen Stammzelltransplantation für Patienten mit Myelofibrose, für die nach einer dreimonatigen Ruxolitinib-Induktionstherapie ein passender Stammzellspender gefunden wurde, mit Patienten, für die kein passender Spender gefunden wurde und die weiterhin Ruxolitinib erhalten.
    E.2.2Secondary objectives of the trial
    To assess and compare the safety and efficacy of study treatments/ induction therapy in both study arms on spleen reduction, improvement of constitutional symptoms, QOL, toxicity, fibrosis regression, development of GvHD as well as chimerism, engraftment, relapse incidence, disease related mortality outcome and overall survival.
    Bewertung und Vergleich der Sicherheit und Wirksamkeit der Studienbehandlungen/ Induktionstherapie in beiden Studien-armen anhand von:
    - Milzverkleinerung
    - Verbesserung des Allgemeinzustandes
    - Lebensqualität
    - Toxizität
    - Rückgang der Fibrose
    - Entwicklung von GvHD sowie Chimerismus
    - Transplantatanwachsen
    - Rezidivhäufigkeit
    - Krankheitsbedingte Sterblichkeit
    - Gesamtüberleben.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Symptomatic primary myelofibrosis or myelofibrosis post polycythaemia vera or essential thrombocythemia stage intermediate 2- or high-risk according to IPSS or DIPSS [46] or inter-mediate 1-risk with high risk cytogenetics, other than normal karyotype, sole del 20q, del 13q, or sole +9, or transfusion-dependency
    2. Patients age: 18 - 70 years at time of inclusion (female and male)
    3. Patients understand and voluntarily sign an informed consent form
    4. Platelet count ≥ 50 x 109/L
    5. No prior Ruxolitinib treatment
    6. ECOG ≤ 2
    1. Symptomatische primäre Myelofibrose oder sekundä-re Myelofibrose oder post-essentielle Thrombozythä-mie-Myelofibrose der mittleren (2-) oder Hoch-Risikogruppe nach IPSS oder DIPSS, oder der mittle-ren (1-) Risikogruppe mit Hochrisiko Zytogenetik, au-ßer normaler Karyotyp, del 20q, del13q oder +9, oder Transfusionsabhängigkeit
    2. Männer und Frauen zwischen 18 und 70 Jahren zum Zeitpunkt des Einschlusses
    3. Fähigkeit des Patienten die Patienteninformation in-haltlich zu verstehen und die Einwilligungserklärung eigenständig und freiwillig zu unterschreiben.
    4. Thrombozytenzahl bei ≥ 50 x 109/L
    5. Keine frühere Ruxolitinib-Behandlung
    6. ECOG-Leistungsstatus von ≤ 2
    E.4Principal exclusion criteria
    1. Severe renal, hepatic, pulmonary or cardiac disease, such as:
    • Total bilirubin, SGPT or SGOT > 3 times upper the normal level
    • Left ventricular ejection fraction < 30 %
    • Creatinine clearance < 30 ml/min
    • DLCO < 35 % and/or receiving supplementary continuous oxygen
    2. Positive serology for HIV
    3. Pregnant or lactating women (positive serum pregnancy test)
    4. Age < 18 and ≥ 71 years.
    5. Uncontrolled invasive fungal infection at time of screening (baseline)
    6. Serious psychiatric or psychological disorders
    7. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
    8. Transformation to AML
    1. Verschiedene Nieren-, Leber-, Lungen- oder Herzerkranungen wie:
    • Gesamt-Bilirubin, SGPT or SGOT > 3fach über Normalwert
    • linksventrikulären Ejektionsfraktion < 30 %
    • Kreatinin-Clearance < 30 ml/min
    • DLCO < 35 % und/oder Erhalt zusätzlichen Sauerstoffs
    2. Positive HIV-Serologie
    3. Schwangere oder stillende Frauen (positiver Serumschwangerschaftstest)
    4. Alter < 18 und ≥ 71 Jahre.
    5. Unkontrollierte invasive Pilzinfektion zum Zeitpunkt des Screenings (baseline)
    6. Schwere psychiatrische oder psychologische Erkrankung
    7. Teilnahme an einer anderen studie mit anhaltender Nutzung von unlizensierten IMP 28 Tage vor Studieneinschluss
    8. Veränderung zu AML
    E.5 End points
    E.5.1Primary end point(s)
    Event free survival (EFS) at 3 years after allogeneic SCT compared to Ruxolitinib continuous therapy in patients without a suitable donor
    Ereignisfreies Überleben bei 3 Jahren nach allogener Stammzelltransplantation im Vergleich zur kontinuierlichen Ruxolitinib-Thearpie bei Patienten für die kein passender Spender gefunden wurde.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ruxolitinib continuous therapy: every second months within the first year and following every third month up to 36 months.
    Allogeneic SCT: after 30 and 100 days after allo-SCT following every six months up to 36 months
    Ruxolitinib Dauertherapie: jeden zweiten Monat innerhalb des ersten Jahres gefolgt von jeden dritten Monat bis zu 36 Monate
    Allogene Stammzelltransplantation: nach 30 und 100 Tagen nach des Transplantation gefolgt von alle sechs Monate bis zu 36 Monaten
    E.5.2Secondary end point(s)
    1. Overall survival at 3 years after allogeneic SCT compared to Ruxolitinib continuous therapy in patients without a suitable donor
    2. Spleen reduction after 3 months of Ruxolitinib induction therapy
    3. Improvement of constitutional symptoms (Loose of weight and night sweat) after 3 months Ruxolitinib induction therapy
    4. Improvement of bone marrow fibrosis after 3 months of Ruxolitinib induction therapy
    5. Incidence of acute graft-versus-host disease on Day +100 after allogeneic SCT according to the Glucksberg scale [ ] revised by Przepiorka et al. [ ] (Appendix 13.3)
    6. Incidence of chronic graft-versus-host disease according to the NIH consensus criteria of Filipovich et al. [ ] (Appendix 13.4) at 1, 2 and 3 years after allogeneic SCT
    7. Toxicity of Ruxolitinib scored according to NCI CTCAE, Version 4.0 (Appendix 13.2)
    8. Toxicity of conditioning therapy scored according to NCI CTCAE, Version 4.0 (Appendix 13.2)
    9. Cumulative incidence of relapse at 3 years after allogeneic SCT
    10. Disease-related mortality at 3 years after allogeneic SCT and Ruxolitinib continuous thera-pies
    11. Non-relapsed mortality at 1 and 3 years after allogeneic SCT and Ruxolitinib continuous therapy
    12. Discontinuation rate at 3 years after Ruxolitinib continuous therapy (End of study)
    13. Evaluation of Sorror Risk Score (see Appendix 13.1) on outcome after allogeneic SCT
    14. Impact of chimerism on relapse incidence after allogeneic SCT
    15. Evaluation of bone marrow fibrosis regression after allogeneic SCT at 30d, 100d, 1 year and 3 years
    16. Evaluation of bone marrow fibrosis regression after Ruxolitinib continuous therapies at 30d, 100d, 1 year and 3 years
    17. Evaluation of QOL (FACT-BMT) and QOL (MPN) before Ruxolitinib induction therapy (= baseline), at transplantation, and after transplantation at 6m, 1 year, 2 years and 3 years
    18. Evaluation of QOL (FACT-BMT) and QOL (MPN) before Ruxolitinib induction therapy (= baseline), at confinement to Ruxolitinib continuous therapy and after confinement at 6m, 1 year, 2 years and 3 years
    1. Gesamtüberleben bei 3 Jahren nach allogener Stammzelltransplantation im Vergleich zur kontinuierlichen Ruxolitinib-Thearpie bei Patienten für die kein passender Spender gefunden wurde
    2. Milzverkleinerung nach 3-monatiger Ruxolitinib-Induktionstherapie
    3. Verbesserung der konstitutionellen Symptome (Gewichts-verlust und Nachtschweiß) nach 3-monatiger Ruxolitinib-Induktionstherapie
    4. Verbesserung der Knochenmarkfibrose nach 3-monatiger Ruxolitinib-Induktionstherapie
    5. Inzidenz eines akuten “Graft-versus-Host Disease” an Tag +100 nach allogener Stammzelltransplantation nach der Glucksberg Skala überarbeitet durch Przepiorka et al.
    6. Inzidenz eines chonischen “Graft-versus-Host Dise-ase” nach den NIH consensus Kriterien von Filipovich et al. nach 1, 2 und 3 Jahren nach allogener Stamm-zelltransplantation
    7. Toxizität von Ruxolitinib eingeordnet nach NCI CTCAE, Version 4.0
    8. Toxizität der Konditionirung eingeordnet nach NCI CTCAE, Version 4.0
    9. Kumulative Rezidivhäufigkeit nach 3 Jahren nach al-logener Stammzelltransplantation
    10. Krankheits-spezifische Mortalität nach 3 Jahren nach allogener Stammzelltransplantation und kontinuierli-cher Ruxolitinib-Therapie
    11. Mortalität ohne Rezidiv nach 1 und 3 Jahren nach al-logener Stammzelltransplantation und kontinuierlicher Ruxolitinib-Therapie
    12. Beendigungsrate nach 3 Jahren kontinuierlicher Ruxolitinib-Therapie (Ende der klinischen Prüfung)
    13. Evaluierung des Sorror Risk Score auf den Therapie-erfolg nach allogener Stammzelltransplantation
    14. Auswirkung des Chimerismus auf die Rezidivhäufig-keit nach allogener Stammzelltransplantation
    15. Evaluierung der Rückbildung der Knochenmark-Fibrose nach allogener Stammzelltransplantation nach 30 und 100 Tagen sowie nach 1 und 3 Jahren
    16. Evaluierung der Rückbildung der Knochenmark-Fibrose unter kontinuierlicher Ruxolitinib-Therapie nach 30 und 100 Tagen sowie nach 1 und 3 Jahren
    17. Evaluierung der Lebensqualität (FACT-BMT und MPN) vor Ruxolitinib-Induktionstherapie (= baseline), bei Transplantation, und 6 Monate sowie 1, 2 und 3 Jahre nach Transplantation
    18. Evaluierung der Lebensqualität (FACT-BMT und MPN) vor Ruxolitinib-Induktionstherapie (= baseline), bei Einschluss in die kontinuierliche Ruxolitinib-Therapie und 6 Monate sowie 1, 2 und 3 Jahre nach kontinuierlicher Ruxolitinib-Therapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ruxolitinib induction therapie: after three months
    Ruxolitinib continuous therapy: every second months within the first year and following every third month up to 36 months.
    Allogeneic SCT: after 30 and 100 days after allo-SCT following every six months up to 36 months
    Ruxolitinib-Induktionstherapy: nach drei Monaten
    Ruxolitinib Dauertherapie: jeden zweiten Monat innerhalb des ersten Jahres gefolgt von jeden dritten Monat bis zu 36 Monate
    Allogene Stammzelltransplantation: nach 30 und 100 Tagen nach des Transplantation gefolgt von alle sechs Monate bis zu 36 Monaten
    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 Yes
    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) 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 concerned20
    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 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
    The end of study is defined as the last follow-up visit of the last patient
    Das Ende der Studie ist definiert als letzte Follow-up-Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state155
    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
    Keine
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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