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    Summary
    EudraCT Number:2011-003824-12
    Sponsor's Protocol Code Number:ProRom
    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:2012-03-13
    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 number2011-003824-12
    A.3Full title of the trial
    Pilot phase II trial on safety and activity of secondary prophylaxis with Romiplostim in patients with non-Hodgkin lymphoma and chemotherapy-induced throm-bocytopenia
    Studio pilota di fase II sulla sicurezza e l'attivita' di una profilassi secondaria con Romiplostim in pazienti con linfoma non-Hodgkin e piastrinopenia chemioindotta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    phase II prospective study on safety and capability of Romiplostim to prevent reduction of platelets due to chemotherapy.
    Studio prospettico di fase II sulla sicurezza e la capacita' di Romiplostim di prevenire la riduzione delle piastrine indotta dalla chemioterapia.
    A.4.1Sponsor's protocol code numberProRom
    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 SponsorFONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
    B.1.3.4CountryItaly
    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 supportAMGEN DOMPE'
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE SAN RAFFAELE DEL MONTE TABOR
    B.5.2Functional name of contact pointDipartimento di Oncoematologia
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number02-26437649
    B.5.5Fax number02-26437625
    B.5.6E-mailferreri.andres@hsr.it
    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 NPLATE*FL 250MCG POLV+SOLV
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN DOMPE' SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder and solvent 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 INNROMIPLOSTIM
    D.3.9.1CAS number 267639-76-9
    D.3.9.4EV Substance CodeSUB27756
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    D.3.11.13.1Other medicinal product typeprodotto di ricombinazione DNA
    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
    chemotherapy-induced thrombocytopenia in patients affected by non-Hodgkin lymphoma
    trombocitopenia chemioindotta in pazienti affetti da linfoma non Hodgkin
    E.1.1.1Medical condition in easily understood language
    platelets reduction induced by chemotherapy in patients affected by non-Hodgkin lymphoma
    riduzione delle piastrine a seguito di chemioterapia in pazienti affetti da linfoma non Hodgkin
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    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 evaluate safety of Romiplostim in patients with newly diagnosed or relapsed NHL who experienced grade-4 chemotherapy-induced thrombocytopenia (CIT) after the first chemotherapy course.
    dimostrare la sicurezza di Romiplostim, definita come incidenza di eventi avversi di grado ≥4 (NCI CTCAE v.4.02 Dec 09) durante il trattamento sperimentale (dopo il secondo ciclo fino alla fine del trattamento chemioterapico).
    E.2.2Secondary objectives of the trial
    To evaluate romiplostim activity by assessing the reduction of grade 4 CIT, CIT duration, number of platelets transfusions, with the possibil-ity to maintain the relative dose intensity of the chemotherapy regimen.
    -valutare l’attività di Romiplostim definita come incidenza di piastrinopenia di grado 4 (&lt;25.000/mcL) ad ogni ciclo chemioterapico durante il trattamento sperimentale; -valutare il tempo di recupero piastrinico da &lt;25.000/mcL a &gt;25.000/mcL dopo ogni ciclo chemioterapico; • valutare il numero di trasfusioni piastriniche necessarie ad ogni ciclo chemioterapico per ciascun paziente dall’arruolamento al termine della chemioterapia; -valutare il numero di eventi emorragici ad ogni ciclo chemioterapico per ciascun paziente dall’arruolamento al termine della chemioterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient with NHL of any histotype, both at diagnosis or at relapse, who experienced grade 4 CIT after the first course of chemotherapy containing high doses of meth-otrexate, cytarabine, cisplatin, cyclo-phosphamide and/or ifosfamide, and/or conven-tional doses of anthracyclines or purine analogs (permitted regimens: CHOP, CHOP-like, FC, FND, DHAP, ICE, IEV, MIV, MTX/araC), with or without rituximab. The same type of chemotherapy where the grade 4 CIT occurred will be continued at the same planned doses for a maximum of 8 courses. -Age ≥18 years. -ECOG performance status score  3. -Signed informed consent. -Adequate bone marrow function (ANC >1.000; Hb >9,5 g/dL; PLT > 75.000).
    -Pazienti con qualunque istotipo di Linfoma non-Hodgkin, sia di nuova diagnosi che recidivato, che presentano piastrinopenia chemioindotta (CIT) di Grado 4 dopo il primo ciclo di chemioterapia contenente alte dosi di methotrexate, citarabina, cisplatino, ciclofosfamide e/o ifosfamide, e/o dosi convenzionali di antracicline o analoghi purinici (e.g. DHAP, ICE, IEV, MIV, MTX/araC, CHOP, FC), con o senza rituximab. Il medesimo regime di chemioterapia nell’ambito del quale si è verificata la CIT di Grado 4 sarà continuato alla stessa dose pianificata per un massimo di 8 cicli. -Età ≥18 years. -ECOG performance status  3. -Firma del consenso informato. -Adeguata funzione midollare (ANC &gt;1.000; Hb &gt;9,5 g/dL; PLT &gt; 75.000)
    E.4Principal exclusion criteria
    -Patients eligible for high-dose chemotherapy, where stem cell sup-port is planned. -Thrombotic events in the previous 5 years before enrolment. -Other malignancies diagnosed in the previous 5 years before enrolment. -Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or car-diac function, uncontrolled diabetes mellitus). -Active infectious disease. -Impaired liver function (bilirubin >2 x upper normal limit; ALT/AST/GGT > 3 x upper normal limit) at one month from salvage chemotherapy conclusion. -Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion. -Non-co-operative behavior or non-compliance. -Psychiatric diseases or conditions that might impair the ability to give informed con-sent. -Pregnant or lactating females (Females subjects of childbearing potential must comply with effective contraception during experimental treatment). -Previous therapy with any TPO-mimetic or similar substances. -Previous therapy supported by transplant of autologous or allogeneic stem cells.
    -Pazienti candidati a chemioterapia ad alte dosi con previsto supporto di cellule staminali. -Eventi trombotici nei 5 anni precedenti l’arruolamento. -Altre patologie maligne diagnosticate nei 5 anni precedenti l’arruolamento. -Patologie concomitanti/condizioni mediche gravi (e.g. funzione respiratoria e/o cardiaca ridotta, diabete mellito non controllato) -Patologie infettive attive. -Funzione epatica ridotta (bilirubina &gt;2 x ULN; ALT/AST/GGT &gt; 3 x ULN) ad un mese dalla conclusione della chemioterapia di salvataggio. -Funzione renale ridotta (clearance della creatinina &lt;50 ml/min) ad un mese dalla conclusione della chemioterapia di salvataggio. -Atteggiamento non collaborativo o non conforme a quanto richiesto dal protocollo. -Patologie psichiatriche o condizioni che possano pregiudicare la capacità di rilasciare il consenso informato. -Gravidanza o allattamento (Le donne potenzialmente fertili devono accettare di adottare efficaci metodi contraccettivi durante il trattamento sperimentale). -Precedente terapia con qualunque mimetico delle trombopoietine o sostanze simili. -Precedente terapia con supporto di trapianto autologo o allogenico di cellule staminali
    E.5 End points
    E.5.1Primary end point(s)
    Romiplostim safety, defined by the incidence of grade > or equal 4 adverse events (NCI CTCAE v. 4.02 Dec 2009) during experimental treatment.
    Profilo di sicurezza di Romiplostim, definito dall’incidenza di eventi avversi di grade > uguale 4 (NCI CTCAE v.4.02 Dec 09) durante il trattamento sperimentale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after second chemotherapy cycle till the end of chemotherapy treatment
    dopo il secondo ciclo di chemioterapia fino al termine del trattamento chemioterapico
    E.5.2Secondary end point(s)
    -Romiplostim activity defined by the incidence of grade 4 CIT ( 25 x 109/L) per chemo-therapy course during experimental treatment. -Recovery time from the first day of platelets count ≤25.000 plt/μL to the achievement of a platelet count of >25.000 plt/μL, summarized by each course. -Number of platelet transfusions per chemotherapy course, per patient, from the enrol-ment to end of chemotherapy. -Number of bleeding events per chemotherapy course, per patient, from the enrolment to end of chemotherapy.
    -Attività di Romiplostim definita dall’incidenza di CIT di grado 4 ( 25 x 109/L) per ciclo di chemioterapia durante il trattamento sperimentale. -Tempo di recupero dal primo giorno con numero di piastrine ≤25.000 plt/μL al raggiungimento del numero di piastrine >25.000 plt/μL, sintetizzati per ciascun ciclo. -Numero di trasfusioni di piastrine per ciclo di chemioterapia, per paziente, dall’arruolamento alla fine della chemioterapia. -Numero di eventi emorragici per ciclo di chemioterapia, per paziente, dall’arruolamento alla fine della chemioterapia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after second chemotherapy cycle till the end of chemotherapy treatment
    dopo il secondo ciclo di chemioterapia fino al termine del trattamento chemioterapico
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVSL
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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 No
    F.1.1Number of subjects for this age range: 0
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Follow Up visits in order to check eventual side effects.
    controlli di Follow Up per 1 anno per il monitoraggio di eventuali effetti collaterali.
    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 Decision2011-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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