Clinical Trials Register

Summary
EudraCT Number:	2022-000633-17
Sponsor's Protocol Code Number:	ALL2922
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:	2022-06-07
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

2022-000633-17

A.3

Full title of the trial

Combination of Ponatinib Plus Chemotherapy As Frontline Treatment For Patients With BCR/ABL1-Like Acute Lymphoblastic Leukemia (BCR/ABL1-Like ALL) - BALLik

Combinazione di ponatinib e chemioterapia come trattamento di prima linea per i pazienti con leucemia acuta linfoblastica BCR/ABL1-like (LAL BCR/ABL1-like) - BALLik

A.3.1

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

The study's aim is to treat adult patients affected by Ph-like ALL, a Philadelphia-negative ALL subtype, with a combination of the tyrosine kinase inhibitor ponatinib and chemotherapy. The main objective of the trial is to improve the percentace of patients that achieve a disease remission also at the molecular level.

Lo studio ha lo scopo di trattare pazienti adulti affetti da LAL PH-Like, un sottotipo di LAL Philadephia-negativa, con un inibitore di tirosin chinasi, il ponatinib, in aggiunta alla chemioterapia. L'obiettivo è quello di migliorare la percentuale di pazienti che ottengono la remissione di malattia anche a livello molecolare.

A.3.2

Name or abbreviated title of the trial where available

ALL2922

A.4.1

Sponsor's protocol code number

ALL2922

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	FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
B.1.3.4	Country	Italy
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	Incyte Biosciences International Sàrl, Docteur-Yersin 12, 1110 Morges, Switzerland
B.4.2	Country	Switzerland
B.4.1	Name of organisation providing support	FONDAZIONE GIMEMA
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 GIMEMA
B.5.2	Functional name of contact point	Centro dati
B.5.3	Address:
B.5.3.1	Street Address	Via Casilina 5
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00182
B.5.3.4	Country	Italy
B.5.4	Telephone number	0670390526
B.5.5	Fax number	0670390540
B.5.6	E-mail	gimema@gimema.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	Iclusig 15 mg compresse rivestite con film
D.2.1.1.2	Name of the Marketing Authorisation holder	Incyte Biosciences Distribution B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	EU/3/09/715
D.3 Description of the IMP
D.3.1	Product name	Iclusig
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Film-coated 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	Ponatinib
D.3.9.1	CAS number	943319-70-8
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Ponatinib
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	30
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	Iclusig 15 mg compresse rivestite con film
D.2.1.1.2	Name of the Marketing Authorisation holder	Incyte biosciences distribution B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	EU/3/09/715
D.3 Description of the IMP
D.3.1	Product name	Iclusig
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Film-coated 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	Ponatinib
D.3.9.1	CAS number	943319-70-8
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Ponatinib
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.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

Adult Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia.

Leucemia acuta linfoblastica Philadelphia-negativa dell'adulto.

E.1.1.1

Medical condition in easily understood language

Acute lymphoblastic leukemia, a blood cancer that begins when the lymphocytes undergo neoplastic transformation in the marrow, with uncontrolled multiplication and progressive accumulation.

Leucemia linfoblastica acuta, malattia tumorale del sangue che inizia quando i linfociti subiscono trasformazione neoplastica nel midollo, con moltiplicazione incontrollata e progressivo accumulo.

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	LLT
E.1.2	Classification code	10000845
E.1.2	Term	Acute lymphoblastic leukemia
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10000845
E.1.2	Term	Acute lymphoblastic leukemia
E.1.2	System Organ Class	100000004864

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

The primary objective is to evaluate the clinical response - in terms of MRD negativity - in patients with a BCR/ABL1-like profile, according to the BCR/ABL1-like predictor tool, treated with Ponatinib in combination with chemotherapy.

L’obiettivo primario dello studio è quello di valutare la risposta clinica – in termini di ottenimento della negatività della malattia minima residua (MMR) – nei pazienti con profilo BCR/ABL1-like, in base al modello predittivo BCR/ABL1-like, trattati con ponatinib in combinazione con la chemioterapia.

E.2.2

Secondary objectives of the trial

To evaluate:
1) MRD monitoring during the different time points of the study treatment
2) Disease Free Survival
3) Event Free Survival
4) Cumulative Incidence of Relapse
5) Overall Survival
¿) Treatment-related mortality (TRM)
7) Clinical response
8) Feasibility of a combination approach with Ponatinib and chemotherapy
9) Safety

Valutazione di:
1) MMR alle varie tempistiche del trattamento
2) Sopravvivenza libera da malattia
3) Sopravvivenza libera da eventi
4) Incidenza cumulativa di recidive
5) Sopravvivenza globale
6) Mortalità trattamento-relata
7) Risposta clinica
8) Fattibilità dell’approccio di combinazione con ponatinib e chemioterapia
9) Profilo di sicurezza

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

Pharmacogenomics
Version: 1.0
Date: 13/01/2022
Title: Traslational Research
Objectives: 1) To investigate the underlying molecular lesion in each BCR/ABL1-like case by performing NGS and copy number aberration analysis. 2) To evaluate, on the basis of the underlying molecular lesion, the efficacy of Ponatinib.

Farmacogenomica
Versione: 1.0
Data: 13/01/2022
Titolo: Ricerca traslazionale
Obiettivi: 1) Investigare le alterazioni molecolari nei casi BCR/ABL1-like mediante sequenziamento di nuova generazione (NGS) e analisi delle alterazioni del numero di copie; 2) Valutare l’efficacia del ponatinib sulla base del tipo di alterazioni molecolari

E.3

Principal inclusion criteria

• Age18-65 years.
• De novo Ph+-like ALL, as defined by the BCR/ABL1-like predictor (13).
• WHO score =2.
• Adequate liver function, as defined by the following criteria: total serum bilirubin =1.5 x upper
limit of normal (ULN), unless due to Gilbert's syndrome, alanine aminotransferase (ALT) =2.5 ×ULN or aspartate aminotransferase (AST) =2.5 x ULN or leukemia related.
• Adequate pancreatic function as defined by serum lipase and amylase =1.5 × ULN or leukemia
related.
• No history of dyslipidemia, thrombotic events or cardiac disease.
• For females of childbearing potential, a negative pregnancy test must be documented. Female
and male patients who are fertile must agree to use an effective form of contraception with their
sexual partners from enrollment through 12 months after the end of treatment.
• Signed informed consent, according to ICH/EU/GCP and national regulation.

• Età 18-65 anni
• Diagnosi di LAL BCR/ABL1-like, stabilita in base al predittore BCR/ABL1-like
• Score WHO = 2
• Adeguata funzionalità epatica, definita in base ai seguenti criteri: bilirubina totale sierica =1.5 x limite normale superiore (ULN), a meno che dovuta alla sindrome di Gilbert, alanina
aminotransferasi (ALT) =2.5 × ULN o aspartato aminotransferasi (AST) =2.5 x ULN a meno che sostenuto dalla leucemia stessa
• Adeguata funzionalità pancreatica definita come lipasi sierica e amilasi =1.5 × ULN a meno che sostenuto dalla leucemia stessa
• Nessuna storia di dislipidemia, eventi trombotici o malattia cardiaca
• Per le donne in età fertile, deve essere documentato un test di gravidanza negativo. Donne e uomini in età fertile devono dare il consenso ad usare un metodo di contraccezione efficiente
durante dall’arruolamento e per il 12 mesi dopo la fine del trattamento.
• Consenso informato firmato in base alle linee guida ICH/EU/GCP e nazionali

E.4

Principal exclusion criteria

• WHO performance status >2.
• Active HBV or HCV hepatitis, or AST/ALT > 2.5 x ULN and bilirubin > 1.5 x ULN.
• History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
• History of alcohol abuse.
• Ongoing or active infections.
• Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).
• Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not
restricted to:
- Any history of myocardial infarction, stroke, or revascularization, unstable angina or transient
ischemic attack within 6 months prior to enrollment,
- Congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction
(LVEF) less than lower limit of normal per local institutional standards,
- History of clinically significant (as determined by the treating physician) atrial arrhythmia,
- Any history of ventricular arrhythmia,
- Any history of venous thromboembolism including deep venous thrombosis or pulmonary
embolism.
• Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients
with hypertension should be under treatment on study entry to effect blood pressure control.
• Taking medications that are known to be associated with torsades de pointes.
• Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4
within at least 14 days before the first dose of ponatinib.
• Creatinine levels > 2.5mg/dl or glomerular filtration rate (GFR) < 20 ml/min or proteinuria
>3.5 g/day.
• Gastrointestinal (GI) function impairment, or a GI disease that may significantly alter the
absorption of study drugs.
• Patients who are currently receiving treatment with any of the medications with potential to prolong QT interval (listed in Appendix F) if the medications cannot be either discontinued or
switched to a different medication prior to starting study drug.
• Patients who have received any investigational drug = 4 weeks.
• Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have
not recovered from side effects of such therapy.
• Patients who are pregnant or breast feeding and adults of reproductive potential not employing
an effective method of birth control (women of childbearing potential must have a negative
serum pregnancy test within 48 hrs. prior to administration of Ponatinib). Postmenopausal women
must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Male and female patients must agree to employ two effective reliable methods of birth control
throughout the study and for up to 12 months following discontinuation of study drugs.
• Patients with a history of another primary malignancy that is currently clinically significant or
currently requires active intervention.
• Patients unwilling or unable to comply with the protocol

•Score WHO >2
• Epatite da HBV o HCV attiva, o AST/ALT > 2.5 x ULN e bilirubina > 1.5 x ULN
• Storia di pancreatite entro 1 anno dallo studio o storia di pancreatite cronica • Storia di alcolismo • Infezioni attive • Ipertrigliceridemia non controllata (trigliceridi 450 mg/dL)
• Malattia cardiovascolare clinicamente rilevante, non controllata o attiva, includendo specificamente ma non esclusivamente: - Ogni storia di infarto del miocardio, ictus, rivascolarizzazione, angina instabile o attacco ischemico transiente entro 6 mesi prima dell’arruolamento
• Insufficienza cardiaca congestizia entro 6 mesi prima dell’arruolamento, o frazione di eiezione del ventricolo sinistro (LIVEF) minore del limite inferiore normale in base agli standard locali
• Storia di aritmia atriale clinicamente rilevante, stabilito dal medico curante • Storia di aritmia ventricolare • Storia di tromboembolismo venoso inclusa la trombosi venosa profonda o l’embolismo polmonare
• Ipertensione incontrollata (pressione diastolica >90 mm Hg; sistolica >140 mm Hg). I pazienti con ipertensione devono essere in trattamento al momento dell’entrata nello studio per controllare la pressione
• Assunzione di farmaci associati alla torsades de pointes • Assunzione di farmaci o integratori noti come inibitori di CYP3A4 nei 14 giorni che precedono la prima dose di ponatinib
• Livelli di creatinina > 2.5mg/dl o tasso di filtrazione glomerulare (GFR) < 20 ml/min o proteinuria >3.5 g/giorno
• Funzionalità gastrointestinale (GI) compromessa o malattia del sistema GI che può alterare l’assorbimento dei farmaci in studio
• Pazienti che stanno assumendo farmaci che potrebbero prolungare l’intervallo QT se il farmaco non può essere interrotto o cambiato con un altro prima dell’inizio del farmaco in studio
• Pazienti che hanno ricevuto farmaci sperimentali da meno di 4 settimane • Pazienti che hanno subito un intervento chirurgico da meno di 2 settimane prima di assumere il farmaco in studio o che non sono guariti dagli effetti collaterali derivanti da questa terapia
• Pazienti in stato di gravidanza o che allattano o adulti fertili che non usano metodi di contraccezione efficaci (le donne in età fertile devono disporre di un test di gravidanza negativo eseguito entro le 48 ore prima della somministrazione di ponatinib). Donne in post-menopausa devo essere amenorroiche da almeno 12 mesi per essere considerate non fertili. Uomini e donne devono acconsentire ad usare almeno due metodi di contraccezione affidabili durante lo studio e per almeno I 12 mesi seguenti all’interruzione dell’assunzione dei farmaci
• Pazienti con una storia di un’altra neoplasia primaria che è ancora clinicamente rilevante o richiede trattamento • Pazienti non disponibili o impossibilitati ad aderire al protocollo

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of this study is to evaluate clinical response - in terms of MRD negativity rate after 3 cycles (TP2) in patients with BCR/ABL1-like ALL treated with a Ponatinib plus chemotherapy approach.

L'endpoint primario dello studio è quello di valutare la risposta clinica – in termini di ottenimento della negatività della malattia minima residua (MMR) dopo 3 cicli (TP2) nei pazienti con profilo BCR/ABL1-like, trattati con ponatinib in combinazione con la chemioterapia.

E.5.1.1

Timepoint(s) of evaluation of this end point

after 3 cycles (TP2)

dopo 3 cicli (TP2)

E.5.2

Secondary end point(s)

1) The rate of MRD negativity at 2 timepoints TP1, TP3.
2) DFS at 24 months
3) EFS at 24 months
4) CIR estimation from CR achievement at 24 months
5) OS at 24 months
6) Treatment-related mortality (TRM)
7) Rate of patients in CR after TP2
8) Rate of patients who undego transplantion and who complete the Chemotherapy plus ponatinib
scheme
9) Rate of Adverse Events (AEs) and Seriuos AEs related to Ponatinib

1) I livelli di MMR a 2 tempi (TP1, TP3)
2) DFS a 24 mesi
3) EFS a 24 mesi
4) CIR stimata dall'ottenimento della CR a 24 mesi
5) OS a 24 mesi
6) TRM
7) Tasso dei pazienti in CR dopo il TP2
8) Tasso dei pazienti che si sottopongono a trapianto e che completano lo schema di trattamento di Chemioterapia e Ponatinib
9) Tasso di Eventi Avversi (AEs) e Gravi relazionati al Ponatinib

E.5.2.1

Timepoint(s) of evaluation of this end point

TP1, TP2, TP3, 24 months

TP1, TP2, TP3, 24 mesi

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

E.8.1.1

Randomised

E.8.1.2

Open

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

Last Visit Last Subject

Ultima visita dell'ultimo paziente

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)

Patients will continue to be followed according to the normal care activity provided by good clinical practice.

I pazienti continueranno ad essere seguiti secondo la normale attività assistenziale prevista dalla buona 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	Fondazione Gimema
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

2022-08-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-06

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

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