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    Summary
    EudraCT Number:2015-000287-34
    Sponsor's Protocol Code Number:ARO-012
    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:2020-12-16
    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 number2015-000287-34
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Trial of Crenolanib in Subjects with Advanced or Metastatic Gastrointestinal Stromal Tumors with a D842V Mutation in the PDGFRA Gene.
    Uno Studio Randomizzato, in doppio cieco, controllato con Placebo, Multicentrico di Crenolanib in Soggetti con Carcinomi Stromali Gastrointestinali Avanzati o con Metastasi con una Mutazione D842V del Gene PDGFRA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study at several locations, randomized, double-blind with crenolanib in comparison with placebo in patients with advanced or metastatic gastrointestinal stromal tumors with a specific mutation (D842V) in the PDGFRA gene.
    Studio in diverse localit¿, randomizzato, in doppio cieco con crenolanib rispetto al placebo nei pazienti con carcinomi stromali gastrointestinali avanzati o con metastasi con una mutazione specifica (D842V) del gene PDGFRA.
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberARO-012
    A.5.4Other Identifiers
    Name:IND NumberNumber:067968
    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 SponsorAROG PHARMACEUTICALS, INC.
    B.1.3.4CountryUnited States
    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 supportArog Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArog Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address5420 LBJ Freeway, Suite 410
    B.5.3.2Town/ cityDallas, TX
    B.5.3.3Post code75240
    B.5.3.4CountryUnited States
    B.5.6E-mailvjain@arogpharma.com
    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 nameCrenolanib
    D.3.2Product code AR-868,596-26
    D.3.4Pharmaceutical form Film-coated 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 INNCrenolanib Besylate
    D.3.9.1CAS number 670220-93-6
    D.3.9.2Current sponsor codeAR-868,596-26
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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 nameCrenolanib
    D.3.2Product code AR-868,596-26
    D.3.4Pharmaceutical form Film-coated 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 INNCrenolanib Besylate
    D.3.9.1CAS number 670220-93-6
    D.3.9.2Current sponsor codeAR-868,596-26
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced or metastatic gastrointestinal stromal tumor (GIST)
    Carcinomi stromali gastrointestinali avanzati o con metastasi
    E.1.1.1Medical condition in easily understood language
    Tumor of the gastrointestinal tract
    Tumore del tratto gastrointestinale
    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 LLT
    E.1.2Classification code 10062427
    E.1.2Term Gastrointestinal stromal tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the treatment effect of crenolanib with that of placebo on prolonging progression-free survival (PFS) in subjects with advanced or metastatic GIST with a PDGFRA D842V mutation.
    Confrontare l'effetto del trattamento di crenolanib con quello di placebo sulla sopravvivenza senza progressione prolungata in soggetti con GIST avanzato o con metastasi con una mutazione D842V PDGFRA.
    E.2.2Secondary objectives of the trial
    To compare the treatment effect of crenolanib with that of placebo on overall survival (OS) and objective response rate (ORR).
    Confrontare l'effetto del trattamento di crenolanib con quello di placebo sulla sopravvivenza globale (OS) e il tasso di risposta oggettivo (ORR).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
    2. Measurable disease as per modified RECIST 1.1
    - A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
    3. Disease progression per modified RECIST 1.1 within 6 months of randomization
    4. Subjects (male or female) = 18 years of age
    5. Adequate bone marrow function, defined as:
    - ANC of = 1000 /µL
    - Platelet count of = 75 x 10^9/L
    6. Adequate hepatic function, defined as:
    - Serum total bilirubin within normal limits
    - Serum aspartate aminotransferase (AST) = 2.0 x upper limit of normal (ULN)
    - Serum alanine aminotransferase (ALT) = 2.0 x ULN
    7. Adequate renal function, defined as:
    - Serum creatinine = 1.5 x ULN or
    - Creatinine clearance estimate of = 50 mL/min (as calculated according to Cokcroft-Gault formula or MDRD formula for subjects > 65 years).
    8. Female subjects with reproductive potential must have negative serum or urine pregnancy test
    Female subjects who meet at least one of the following criteria are defined as women of non-reproductive potential:
    - =50 years old and naturally amenorrheic for = 1 year
    - Permanent premature ovarian failure confirmed by a gynecologist
    - Previous bilateral salpingo-oophorectomy
    - XY genotype, Turner's syndrome, or uterine agenesis
    9. Prior treatment with imatinib, sunitinib, regorafenib, dasatinib and/or nilotinib is allowed. Recovered from prior treatment-related toxicity to Grade = 2 per CTCAE v4.03 or the subject's baseline preceding the prior treatment.
    10. Eastern Cooperative Oncology Group (ECOG) performance status of = 2
    11. Adequate contraception:
    - Female subjects with reproductive potential in combination with their partner must use 2 forms of highly effective methods of contraception during study treatment and for at least 30 days after ending treatment
    - Male subjects in combination with their partner must use 2 forms of highly effective methods of contraception during study treatment and for at least 90 days after ending treatment
    12. Written informed consent before any study-specific procedure is performed
    1. GSIT avanzato o con metastasi confermato a livello istologico o citologico con una mutazione D842V nel gene PDGFRA come determinato dagli esperimenti di laboratorio centrale
    2. Malattia misurabile secondo il RECIST 1.1 modificato
    - Una lesione in un'area che è stata precedentemente trattata con terapia locale (ad es. radiazione, chirurgia o crioterapia) può essere considerata una malattia misurabile finché c'è evidenza oggettiva dell'avanzamento della malattia prima della randomizzazione
    3. Progressione della malattia secondo il RECIST 1.1 modificato entro 6 mesi dalla randomizzazione
    4. Soggetti (maschio o femmina) = 18 anni di età entro la data della firma del modulo di consenso informato
    5. Adeguata funzione del midollo osseo, definita come:
    - ANC di = 1000 /µL
    - Conteggio piastrine di = 75 x 109/L
    6. Adeguata funzione epatica, definita come:
    - Bilirubina totale nel siero entro i normali limiti di ciascun ente
    - Aspartate aminotransferase nel siero (AST) = 2.0 x limite superiore di normale (ULN)
    - Alanina amminotransferasi nel siero (ALT) = 2.0 x ULN
    7. Adeguata funzione renale, definita come:
    - Creatinina nel siero = 1.5 x ULN o
    - Valutazione dell'eliminazione della creatina di = 50 mL/min (come calcolato secondo la formula Cokcroft-Gault o la formula MDRD per soggetti > 65 anni).
    8. I soggetti femminili con potenziale riproduttivo devono riportare analisi del siero o test di gravidanza delle urine negativi
    I soggetti femminili che soddisfano almeno uno dei seguenti criteri sono definiti come donne non in età fertile:
    - = 50 anni e naturalmente amenorreiche per = 1 anno
    - Insufficienza ovarica prematura permanente confermata da un ginecologo
    - Precedente salpingo-ovarectomia bilaterale
    - Genotipo XY, sindrome di Turner o agenesia di utero
    9. È consentito precedente trattamento con imatinib, sunitinib, regorafenib, dasatinib e/o nilotinib. Ripresa da precedente tossicità relative al trattamento al grado = 2 per CTCAE v4.03 o base del soggetto precedente al trattamento
    10. Stato di prestazione del gruppo di oncologia cooperativa dell'est (ECOG) di = 2
    11. Adeguata contraccezione:
    - I soggetti femminili con potenziale riproduttivo in combinazione con il loro partner devono usare 2 forme di metodi contraccettivi altamente efficaci durante il trattamento dello studio e per almeno 30 giorni dopo aver terminato il trattamento
    - I soggetti maschi in combinazione con il loro partner devono usare 2 forme di metodi contraccettivi altamente efficaci durante il trattamento dello studio e per almeno 90 giorni dopo aver terminato il trattamento
    12. La firma del consenso informato scritto prima di qualsiasi procedura specifica dello studio è eseguita
    E.4Principal exclusion criteria
    1. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
    2. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
    - Active infection with HBV is defined as:
    o Acute hepatitis B (diagnosed < 6 months prior to randomization), or
    o Serologic test positive for HBV surface antigen (HBsAg) positive, or
    o Serologic test positive for immunoglobulin (IgM) to HBV core antigen (IgM anti-HBc)
    - Active infection with HCV is defined as:
    o Acute hepatitis C (diagnosed < 6 months prior to randomization), or
    o Positive for HCV ribonucleic acid (RNA)
    Subjects with history of positive anti-HCV screening test (e.g. enzyme immune-assay [EIA], chemiluminescence immunoassay [CIA], or recombinant immunoblot assay [RIA]) should be tested for HCV RNA
    3. History of other malignancy within the past 3 years, except:
    - Malignancy treated with curative intent and with no evidence of disease and considered to be at low risk of recurrence by the treating physician
    - Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease
    - Adequately treated cervical carcinoma in situ with no evidence of disease
    - Adequately treated breast ductal carcinoma in situ with no evidence of disease
    - Adequately treated prostatic intraepithelial neoplasia with no evidence of disease
    - Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ with no evidence of disease
    4. Any disorder that compromises the subject's ability to give written informed consent and/or to comply with study procedures
    5. Any severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator, may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results
    6. Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
    7. Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug's halflife in subject is known) prior to randomization, whichever is shorter
    8. Prior administration of crenolanib
    1. Malattia epatica grave (ad es. cirrosi, steatosi non alcolica, colangite sclerosante)
    2. Infezione conosciuta, attiva con virus dell'epatite B (HBV) o epatite C (HCV)
    - L'infezione attiva con HBV è definita come:
    o Epatite B acuta (diagnosticata < 6 mesi prima della randomizzazione), oppure
    o Test sierologico positivo per l'antigene di superficie HBV (HBsAg) positivo, oppure
    o Test sierologico positivo per immunoglobulina (IgM) all'antigene del nucleo HBV (IgM anti-HBc)
    - L'infezione attiva con HCV è definita come:
    o Epatite C acuta (diagnosticata < 6 mesi prima della randomizzazione), oppure
    o Positiva per acido ribonucleico HCV (RNA)
    I soggetti con storia di test di screening anti-HCV positivo (ad es. immunodosaggio enzimatico [EIA], immunodosaggio chemiluminescenza [CIA] o dosaggio blot ricombinato [RIA]) devono essere testati per HCV RNA
    3. Storia di altre malattie negli ultimi 3 anni, eccetto:
    - La malattia trattata con intento curativo e senza evidenza di malattia e considerata a basso rischio di recidiva dal medico
    - Carcinoma della pelle non melanoma o lentigo maligna tratti in modo adeguato senza evidenza della malattia
    - Carcinoma cervicale trattato in modo adeguato in situ senza evidenza della malattia
    - Carcinoma duttale al seno trattato in modo adeguato in situ senza evidenza della malattia
    - Neoplasia intraepiteliale prostatica trattata in modo adeguato in situ senza evidenza della malattia
    - Carcinoma non invasivo papillifero uroteliale trattato in modo adeguato in situ senza evidenza della malattia
    4. Qualsiasi disturbo che compromette l'abilità del soggetto a dare consenso informato scritto e/o a conformarsi alle procedure dello studio
    5. Qualsiasi condizione medica o fisica grave e/o non controllata che secondo il ricercatore può ostacolare il soggetto nel completamento dello studio, interferire con la valutazione della sicurezza e/o efficacia o interferire con l'interpretazione dei risultati dello studio
    6. Soggetto femmina incinta o in età fertile o che sta programmando di rimanere incinta entro 30 giorni dopo la fine del trattamento
    7. Trattamento antitumorale sistemico (ad es. chemioterapia, inibitori della chinasi della tirosina, immunoterapia o agenti sperimentali) o dispositivo di sperimentazione entro 3 settimane o 5 emivite (se l'emivita del farmaco in oggetto è conosciuta) prima della randomizzazione, a seconda di quale è applicato prima
    8. Precedente somministrazione di crenolanib
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    Sopravvivenza senza progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    35 months
    35 mesi
    E.5.2Secondary end point(s)
    Overall survival; Objective response rate (based on modified RECIST 1.1)
    Sopravvivenza globale (OS); Tasso di risposta oggettivo (ORR) (in base al RECIST 1.1 modificato)
    E.5.2.1Timepoint(s) of evaluation of this end point
    35 months;
    35 months
    35 mesi; 35 mesi
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Norway
    Poland
    Spain
    Switzerland
    United Kingdom
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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 finishing all study relevant procedures, therapy and follow-up period, the patient will be followed in terms of routine aftercare and treated if necessary by the primary responsible hematology/oncology center.
    Dopo aver terminato tutte le procedure rilevanti di studio, la terapia e follow-up, il paziente sar¿ seguito in termini di post-terapia di routine e trattata, se necessario, il principale responsabile del centro di ematologia / oncologia.
    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 Decision2017-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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