Clinical Trials Register

Summary
EudraCT Number:	2015-003168-35
Sponsor's Protocol Code Number:	IELSG40
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:	2022-01-20
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

2015-003168-35

A.3

Full title of the trial

A phase II trial addressing feasibility and activity of clarithromycin + lenalidomide combination: a full oral treatment for patients with relapsed/ refractory extranodal mucosa-associated lymphoid tissue (MALT) lymphoma (CLEO Study)

Studio di Fase II di fattibilit¿ della combinazione claritromicina + lenalidomide: un trattamento orale per pazienti con linfoma del tessuto linfoide associato alla mucosa (MALT) recidivante o refrattario (Studio CLEO)

A.3.1

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

A study with the aim to evaluate the antitumor activity of a new association of oral drugs, lenalidomide and clarithromycin in patients with lymphoma (MALT), when standard treatment with radiation therapy, chemotherapy and / or immunotherapy have shown a lack of efficacy.

Studio che si propone di valutare l¿attivit¿ antitumorale di una nuova associazione di farmaci orali, lenalidomide e claritromicina, nei pazienti con linfoma (MALT), quando i trattamenti standard con radioterapia, chemioterapia e/o immunoterapia hanno mostrato una mancanza di efficacia.

A.3.2

Name or abbreviated title of the trial where available

A study with the aim to evaluate the antitumor activity of a new association of oral drugs, lenalido

Studio CLEO

A.4.1

Sponsor's protocol code number

IELSG40

A.5.4

Other Identifiers

Name:

Studio CLEO

Number:

IELSG 40

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	Switzerland
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 EUROPE LIMITED
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP
B.5.2	Functional name of contact point	Study Coordination Office
B.5.3	Address:
B.5.3.1	Street Address	Via Ospedale - CH-6500 Bellinzona
B.5.3.2	Town/ city	BELLINZONA
B.5.3.3	Post code	6500
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41 91 811 90 60
B.5.5	Fax number	+41 91 811 91 82
B.5.6	E-mail	ielsg@eoc.ch

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 - 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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	LENALIDOMIDE
D.3.2	Product code	NA
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	NA
D.3.9.3	Other descriptive name	REVLIMID
D.3.9.4	EV Substance Code	SUB25389
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	No
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 - 15 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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	LENALIDOMIDE
D.3.2	Product code	NA
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	NA
D.3.9.3	Other descriptive name	LENALIDOMIDE
D.3.9.4	EV Substance Code	SUB25389
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	15
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	No
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	CLARITROMICINA DOC GENERICI - 500 MG COMPRESSE RIVESTITE CON FILM 14 COMPRESSE IN BLISTER PVC/PVDC
D.2.1.1.2	Name of the Marketing Authorisation holder	DOC GENERICI SRL
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	CLARITROMICINA
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Tablet
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	CLARITROMICINA
D.3.9.1	CAS number	81103-11-9
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	CLARYTHROMICIN
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	500
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	No
D.IMP: 4
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 - 20 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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
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	NA
D.3.9.3	Other descriptive name	LENALIDOMIDE
D.3.9.4	EV Substance Code	SUB25389
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	20
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	No

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 lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy.

Pazienti con linfoma del tessuto linfoide associato alla mucosa (MALT) per i quali i trattamenti standard con radioterapia, chemioterapia e/o immunoterapia hanno mostrato una mancanza di efficacia.

E.1.1.1

Medical condition in easily understood language

Patients with an aggressive form of cancer that affects the cells and tissues that are responsible for defending the body against external agents and against disease, ensuring proper circulation of fl

Pazienti con una forma aggressiva di tumore che colpisce le cellule e i tessuti che hanno il compito di difendere l'organismo dagli agenti esterni e dalle malattie e di garantire una corretta circolaz

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	10015823
E.1.2	Term	Extranodal marginal zone B-cell lymphoma (MALT type) recurrent
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10015824
E.1.2	Term	Extranodal marginal zone B-cell lymphoma (MALT type) refractory
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

To assess the overall response rate (complete and partial responses) of the combination treatment of clarithromycin and lenalidomide (Revlimid) in patients with MALT lymphoma, refractory or relapsing after radiotherapy and/or chemotherapy and/or immunotherapy.

Valutare la percentuale complessiva di risposta (risposte complete e parziali) del trattamento combinato di claritromicina e lenalidomide (Revlimid) in pazienti con linfoma MALT, refrattario o recidivante, dopo radioterapia e / o chemioterapia e / o immunoterapia.

E.2.2

Secondary objectives of the trial

- To evaluate the safety profile of the clarithromycin + lenalidomide combination, including any late adverse reactions
- To assess the progression-free survival after clarithromycin+ lenalidomide therapy
- To assess the time to progression after clarithromycin + lenalidomide therapy
- To assess the overall survival after clarithromycin + lenalidomide therapy

Valutare il profilo di sicurezza della combinazione claritromicina e lenalidomide, comprese le eventuali reazioni avverse tardive.
- Valutare la sopravvivenza libera da progressione dopo terapia con lenalidomide e claritromicina
- Valutare il tempo alla progressione dopo terapia con lenalidomide e claritromicina
- Valutare la sopravvivenza dopo la terapia con lenalidomide e claritromicina

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Histologically verified diagnosis of MALT lymphoma arising at any extranodal site
- Disease refractory to or in first or greater relapse after prior radiotherapy and/or chemotherapy and/or immunotherapy
- Measurable or non-measurable lesions where the response is nevertheless evaluable by non-imaging means (e.g., gastric or bone marrow infiltrations)
- Ann Arbor Stage I-IV
- Adequate cardiac, renal and liver function tests (LVEF > 40%, serum creatinine < 2.5 mg/dl, ALAT or ASAT < 2.5 x upper limit of normal range, alkaline phosphatase < 2.5 x upper limit of normal range, serum bilirubin < 2.0 mg/dl)
- Female patients of childbearing potential must agree to use, and be able to comply with, effective contraception and agree to have medically supervised pregnancy tests prior to starting the study
treatment and during therapy
- Male patients must agree to always use a condom during any sexual contact with females of reproductive potential and agree to not donate sperm while taking lenalidomide

- Conferma istologica di diagnosi di linfoma MALT derivante in qualsiasi sito extranodale
- Malattia refrattaria o recidivante (prima o successive recidive) dopo radioterapia e / o chemioterapia e / o immunoterapia
- Lesioni misurabili o non-misurabili dove la risposta è tuttavia valutabile con mezzi non-imaging (ad esempio, infiltrazioni del gastrico o midollo osseo)
- Ann Arbor Stadio I-IV
- Test di funzionalità cardiaca, renale ed epatica corretti (FEVS> 40%, creatinina sierica <2,5 mg / dl, ALAT o ASAT <2,5 volte il limite superiore del range normale, fosfatasi alcalina <2,5 volte il limite
superiore del range normale, bilirubina sierica <2.0 mg / dl)
- Pazienti di sesso femminile in età fertile devono accettare di usare, ed essere in grado di attenersi a una contraccezione efficace e accettare di fare il test di gravidanza sotto controllo medico prima di iniziare il trattamento in studio e durante la terapia
- I pazienti di sesso maschile devono accettare di usare sempre il preservativo durante qualsiasi rapporto sessuale con donne potenzialmente fertili e accettare di non essere donatore di sperma
durante l'assunzione di lenalidomide

E.4

Principal exclusion criteria

- Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma (“high gradelymphoma”) - component
- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix within the last 5 years unless in complete remission since at least 3 years
- Dependency on red blood cell and/or platelet transfusions
- Evidence of central nervous system involvement
- Severe peripheral polyneuropathy
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months and/or long QT-syndrome
- Presence of active opportunistic infections
- Pregnancy or lactation
- Uncontrolled diabetes mellitus
- Pre-existing thromboembolic conditions at study entry

- Istologia del linfoma diverso da linfoma MALT oppure linfoma MALT con componente di linfoma diffuso a grandi cellule (linfoma ad alto grado)
- Storia di tumore maligno diverso da carcinoma squamoso o basocellulare della pelle o carcinoma in situ della cervice uterina negli ultimi 5 anni, a meno di remissione completa da almeno 3 anni
- Dipendenza da trasfusioni di globuli rossi e/o piastrine
- Evidenza di coinvolgimento del sistema centrale nervoso
- Polineuropatia periferica grave
- Cardiopatia clinicamente significativa (ad esempio, insufficienza cardiaca congestizia, malattia coronarica e aritmie cardiache sintomatiche non ben controllate con i farmaci) o infarto del miocardio
negli ultimi 6 mesi e / o sindrome del prolungamento del QT
- Presenza di infezioni opportunistiche attive
- Gravidanza o allattamento
- Diabete mellito non controllato
- Condizioni tromboemboliche pre-esistenti all'inizio dello studio

E.5 End points

E.5.1

Primary end point(s)

Tumor response assessed according to the international Revised Response Criteria for Malignant Lymphoma (Cheson et al) and the GELA
(Group d'Etude des Lymphomes de l'Adulte) histological scoring system for post-treatment biopsies of patients with gastric MALT lymphoma.
The overall response rate will be represented by the total number of complete and partial responses.

Risposta del tumore valutata secondo i criteri di risposta rivisti per Linfoma Maligno, sia clinicamente o endoscopicamente e istologicamente (in pazienti affetti da linfoma gastrico, secondo il sistema GELA [Gruppo d'Etude des Lymphomes de l'Adulte]. Il tasso di risposta globale (ORR) è rappresentato dal numero totale di risposte complete e parziali.

E.5.1.1

Timepoint(s) of evaluation of this end point

For the whole duration of the study

Per tutta la durata dello studio

E.5.2

Secondary end point(s)

- Adverse events incidence, severity and relationship to study treatment
- Time from first investigational medicinal product administration to assessment of disease progression or death due to any cause
- Time from first investigational medicinal product administration to assessment of disease progression or death due to progression
4-Time from first IMP administration to patient¿s death

- Incidenza, gravit¿ e relazione di eventi avversi emergenti dal trattamento di studio
- Tempistica dalla prima somministrazione di farmaco sperimentale fino alla valutazione della progressione di malattia o di morte per qualsiasi
causa
- Tempistica dalla prima somministrazione di farmaco sperimentale fino alla valutazione della progressione di malattia o di morte dovuta a
progressione
- Tempistica dalla prima somministrazione di farmaco sperimentale al decesso

E.5.2.1

Timepoint(s) of evaluation of this end point

For the whole duration of the study

Per tutta la durata dello studio

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

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

E.8.1.1

Randomised

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)

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

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 after 10 years follow-up

LVLS dopo 10 anni di follow-up

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)

Yes

F.1.2.1

Number of subjects for this age range:

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

F.4.2.2

In the whole clinical trial

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)

Standard therapy for the pathology

Terapia standard per la patologia

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-12-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-11-10

P. End of Trial
P.	End of Trial Status	Ongoing

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