Clinical Trials Register

Summary
EudraCT Number:	2016-003116-12
Sponsor's Protocol Code Number:	IELSG45
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-08-30
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-003116-12

A.3

Full title of the trial

Randomized Phase II Trial on Fitness- and Comorbidity- Tailored Treatment in Elderly Patients with Newly Diagnosed Primary CNS Lymphoma (FIORELLA Trial)

Studio clinico di Fase II randomizzato sul trattamento personalizzato (sulla base di fitness e comorbidità) dei pazienti anziani con linfoma primitivo del sistema nervoso centrale di nuova diagnosi.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Randomized Phase II Trial on Tailored Treatment in Elderly Patients with Newly Diagnosed Primary CNS Lymphoma (FIORELLA Trial)

Studio clinico di Fase II randomizzato sul trattamento personalizzato dei pazienti anziani con linfoma primitivo del sistema nervoso centrale di nuova diagnosi.

A.3.2

Name or abbreviated title of the trial where available

FIORELLA trial / IELSG45

Studio FIORELLA / IELSG45

A.4.1

Sponsor's protocol code number

IELSG45

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	IELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP
B.1.3.4	Country
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Celgene
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	AIFA - Italian Medicines Agency
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FONDAZIONE ITALIANA LINFOMI ONLUS
B.5.2	Functional name of contact point	Borgo Elena
B.5.3	Address:
B.5.3.1	Street Address	VIA DEL POZZO 71
B.5.3.2	Town/ city	MODENA
B.5.3.3	Post code	41124
B.5.3.4	Country	Italy
B.5.4	Telephone number	0594225845
B.5.5	Fax number	0594223602
B.5.6	E-mail	startup@filinf.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	REVLIMID - 25 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	CELGENE EUROPE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	DLBCL:EU/3/11/868; CLL: EU/3/07/494 MDS;: EU/3/04/
D.3 Description of the IMP
D.3.1	Product name	REVLIMID/LENALIDOMIDE
D.3.2	Product code	[1]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.2	Current sponsor code	LENALIDOMIDE
D.3.9.3	Other descriptive name	LENALIDOMIDE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	antineoplastico immunomodulatore
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	REVLIMID - 5 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CASPULE
D.2.1.1.2	Name of the Marketing Authorisation holder	CELGENE EUROPE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	DLBCL:EU/3/11/868; CLL: EU/3/07/494 MDS;: EU/3/04/
D.3 Description of the IMP
D.3.1	Product name	LENALIDOMIDE/REVLIMID
D.3.2	Product code	[2]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomde
D.3.9.1	CAS number	191732-72-6
D.3.9.2	Current sponsor code	Lenalidomide
D.3.9.3	Other descriptive name	Lenalidomide
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	ANTINEOPLASTICO E IMMUNOMODULATORE
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	REVLIMID - 10 MG CAPSULA RIGIDA - USO ORALE BLISTER (PCTFE/PVC/ALU) 21 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	CELGENE EUROPE LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	DLBCL:EU/3/11/868; CLL: EU/3/07/494 MDS;: EU/3/04/
D.3 Description of the IMP
D.3.1	Product name	LENALIDOMIDE/REVLIMID
D.3.2	Product code	[3]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.2	Current sponsor code	Lenalidomide
D.3.9.3	Other descriptive name	Lenalidomide
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	ANTINEOPLASTICO E IMMUNOMODULATORE

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with newly diagnosed primary central nervous system lymphoma with age =70 years old

Pazienti di nuova diagnosi con linfoma primitivo del sistema nervoso centrale con età > uguale a 70 anni

E.1.1.1

Medical condition in easily understood language

Patients with a diagnosis of primary central nervous system lymphoma with age =70 years old

Pazienti in cui è stato diagnosticato un linfoma primitivo del sistema nervoso centrale e hanno un età uguale o maggiore di 70 anni

E.1.1.2

Therapeutic area

Diseases [C] - Blood and lymphatic diseases [C15]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10007953
E.1.2	Term	Central nervous system lymphoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

PART A, randomized
To compare the efficacy of a new maintenance treatment consisting of oral lenalidomide with the oral procarbazine maintenance currently in use, in elderly (=70 years) patients with newly diagnosed PCNSL eligible to receive HD-MTX-based induction chemo-immunotherapy. The primary efficacy endpoint is the 2-year PFS
Part B, non randomized
To evaluate the efficacy of concomitant chemo-immuno-radiotherapy administered as induction treatment, followed by temozolomide maintenance in elderly (=70 years) patients with newly diagnosed PCNSL ineligible to receive HD-MTXbased induction chemo-immunotherapy.The primary efficacy endpoint is the 2-year PFS

PARTE A, Randomizzata
È quello di confrontare l'efficacia di un nuovo trattamento di mantenimento costituito da lenalidomide o procarbazina (attualmente in uso), somministrate per via orale, in pazienti anziani (= 70 anni) con nuova diagnosi di PCNSL, idonei a ricevere alte dosi di metotressato durante la fase di induzione.
L'obiettivo primario di efficacia è la percentuale di PFS a 2 anni.
PARTE B, non randomizzara
è quello di valutare l'efficacia della chemio-immunoradioterapia somministrata come trattamento di induzione, seguita da una fase di mantenimento con temozolomide in pazienti anziani (= 70 anni) con nuova diagnosi di PCNSL, non idonei a ricevere durante la fase di induzione alte dosi di metotressato.
L'endpoint primario di efficacia è la PFS a 2 anni.

E.2.2

Secondary objectives of the trial

PART A, Randomized:
To evaluate: The ability of the induction and maintenance treatment to induce
objective tumor responses; Duration of response; Relapse rates and patterns; Overall survival, Incidence and severity of adverse events and adverse reactions.
Prognostic role of geriatric assessments: CIRS, IADL, ADL, and G8.

Part B, non randomized:
To evaluate: The ability of the induction and maintenance treatment to induce objective tumor responses; Duration of response; Relapse rates and patterns; Overall survival, Incidence and severity of adverse events and adverse reactions.
Prognostic role of geriatric assessments: CIRS, IADL, ADL, and G8.

PARTE A; randomizzata:
sono confrontare l'effetto di lenalidomide e procarbazina durante il mantenimento in termini di: Durata della risposta (remissione parziale [PR] e remissione completa [CR]); Sopravvivenza globale; Percentuale di Profilo di sicurezza, Neurotossicità precoce e tardiva, incidenza e gravità degli eventi avversi
Ruolo prognostico della valutazione Geritatrica: CIRS, IADL, ADL e G8

Parte B non randomizzata:
Capacità da parte del trattamento di induzione e di mantenimento a indurre risposte tumorali obiettive; Durata della risposta; Percentuale e tipo di ricaduta; Sopravvivenza globale, Neurotossicità precoce e tardiva; incidenza e gravità degli eventi avversi
Ruolo prognostico della valutazione Geritatrica: CIRS, IADL, ADL e G8

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Life quality
Version: 3.0
Date: 01/09/2017
Title: Quality of life
Objectives: questionnaire to assess the quality of life

Other types of substudies
Specify title, date and version of each substudy with relative objectives: translational study protocol V2 17.08.18 to evaluate the cell of origin (COO)

Qualita' della vita
Versione: 3.0
Data: 01/09/2017
Titolo: EORTC QLQ-C30
Obiettivi: questionario qualità della vita

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: studi traslazionali protocollo V2 17.08.18 per determinare la cell of origin (COO)

E.3

Principal inclusion criteria

- Histologically or cytologically assessed diagnosis of CD20+ diffuse large B-cell lymphoma.
- Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
- Lymphoma exclusively localized in the central nervous system (brain parenchyma and/or meningeal/CSF dissemination and/or eyes and/or cranial nerves).
- Previously untreated patients (previous or ongoing steroid therapy admitted).
- Age =70 years
- Patients not eligible for high-dose chemotherapy supported by autologous stem cell transplant
- ECOG PS =3.
- Adequate bone marrow, cardiac, renal, and hepatic function
- No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least for 3 years (patients with a previous lymphoma at any time are NOT eligible).
- Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- No concurrent treatment with other experimental drugs.
- Patients receiving oral lenalidomide or procarbazine must agree to avoid sharing the study medication with another person and to return all unused study drug to the investigator.
- Male patients must agree to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide, during dose interruptions and for up to 7 days after treatment discontinuation, even if they have undergone a successful vasectomy.
- Informed consent from the patient, or legal representative, obtained before registration.

- Diagnosi istologica o citologica di linfoma diffuso a grandi cellule B CD20+.
- Campione diagnostico ottenuto mediante biopsia stereotassica o chirurgica, esame citologico del liquido cerebrospinale o vitrectomia.
- Linfoma esclusivamente localizzato nel sistema nervoso centrale (parenchima cerebrale e/o meningeo e/o diffusione nel liquido cerebrospinale e/o occhi e/o nervi cranici).
- Pazienti non trattati precedentemente (precedente o attuale terapia steroidea ammessa).
- Età =70 anni
- Pazienti non eleggibili ad alte dosi di chemioterapico supportati da trapianto di cellule staminali autologhe.
- ECOG PS =3.
- Funzionalità midollare, cardiaca, renale ed epatica adeguate
- Nessuna neoplasia precedente o concomitante ad eccezione del carcinoma della cervice chirurgicamente curato in-situ, carcinoma della pelle o altri tipi di tumore, senza evidenza di malattia per almeno 3 anni (pazienti con un precedente linfoma NON sono ammissibili).
- Assenza di qualsiasi condizione familiare, sociologica o geografica potenzialmente ostacolante in accordo con il protocollo di studio e il programma di follow-up.
- Nessun trattamento concomitante con altri farmaci sperimentali.
- Pazienti che ricevono lenalidomide o procarbazina per via orale devono accettare di evitare di condividere il farmaco in studio con un’altra persona e devono restituire tutto il farmaco inutilizzato al medico di studio
- I pazienti di sesso maschile devono accettare di usare sempre il preservativo durante qualsiasi rapporto sessuale con donne potenzialmente fertili mentre assumono lenalidomide e durante le interruzioni di dose, per un massimo di 7 giorni dopo la sospensione del trattamento, anche se hanno subito una vasectomia.
- Il consenso informato deve essere ottenuto dal paziente o legale rappresentativo prima della registrazione

E.4

Principal exclusion criteria

- Lymphoma entity other than diffuse large B-cell lymphoma.
- Extra-CNS disease.
- Lymphoma exclusively localized in the eyes
- Lymphoma infiltration of the cranial nerves as exclusive site of disease
- Previous antineoplastic treatment for the PCNSL.
- Patients eligible for ASCT.
- HBsAg- and HCV-positive patients; HBsAg- and HCV-positive patients. HBcAb+ is not exclusion criteria in the absence of detectable levels HBVDNA.
- HIV disease or immunodeficiency.
- Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus despite optimal medical management).
- Active infectious disease.
- Hypersensitivity to any active principle and/or any excipient according to the contraindications reported in the Summary of Product Characteristics (SmPCs) of the anticancer drugs used in the study

- Linfoma diverso da quello diffuso a grandi cellule B
- Malattie extra-SNC
- Linfoma localizzato esclusivamente agli occhi
- Infiltrazione del linfoma nei nervi cranici come luogo esclusivo di malattia
- Precedente trattamento antineoplastico per il PCNSL
- Pazienti che possono beneficiare di ASCT
- Pazienti HBsAg- e HCV- positivi; pazienti HBsAg- e HCV- positivi; HBcAb+ non è da considerarsi un criterio di esclusione se in assenza di livelli rilevabili di HBVDNA
- HIV o immunodeficienza
- Gravi malattie concomitanti/condizioni mediche (ad esempio attività respiratoria compromessa e/o funzione cardiaca, diabete mellito non controllato nonostante terapia medica).
- Malattia infettiva attiva
- Ipersensibilità a qualsiasi principio attivo e/o qualsiasi eccipiente secondo le controindicazioni riportate nel Riassunto delle Caratteristiche del Prodotto (RCP) dei farmaci antitumorali utilizzati nello studio

E.5 End points

E.5.1

Primary end point(s)

It is the 2-year progression-free survival rate. Progression-free survival will be calculated from maintenance treatment start to relapse/progression or death due to any cause, whichever occurs earlier.

é la percentuale di sopravvivenza libera da progressione a 2 anni. La sopravvivenza libera da progressione sarà calcolata dall’inizio del trattamento di mantenimento alla ricaduta/progressione o alla morte per qualsiasi causa, a seconda di cosa si verifichi prima

E.5.1.1

Timepoint(s) of evaluation of this end point

30 months

30 mesi

E.5.2

Secondary end point(s)

1. Duration of response (Partial remission [PR] and Complete Remission [CR])
2. Overall survival
3. Relapse rates and patterns
4. Safety profile
5. Early and late neurotoxicity; Prognostic Role of geriatric assessments: CIRS, IADL, ADL and G8.

1. Durata della risposta (remissione parziale [PR] e remissione completa
[CR])
2. Sopravvivenza globale
3. Percentuale di ricaduta
4. Profilo di sicurezza
5. Neurotossicità precoce e tardiva
; Ruolo prognostico della valutazione Geriatrica: CIRS, IADL, ADL, e G8

E.5.2.1

Timepoint(s) of evaluation of this end point

30 months; Before the treatment

30 mesi; Prima del trattamento

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Switzerland

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

118

F.4.2.2

In the whole clinical trial

208

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)

The clinical trial has not providet treatments after it. Tharapy will be continueld by physician discrection following the the standard therapies

il protocollo non prevede specifici programmi. Si proseguirà a descrizione del medico curante e secondo pratica clinica

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Istituto San Raffaele
G.4.3.4	Network Country	Italy

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-11-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-12-12

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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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