Clinical Trials Register

Summary
EudraCT Number:	2021-001385-38
Sponsor's Protocol Code Number:	WIN-HYPO2021
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:	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

2021-001385-38

A.3

Full title of the trial

RANDOMIZED STUDY TO PROTECT FROM RADIATION IATROGENIC HYPOTHYROIDISM PATIENTS WITH MEDULLOBLASTOMA (ANY AGE, STAGE AND ANY BIOLOGICAL RISK) AND PEDIATRIC PATIENTS WITH HODGKIN LYMPHOMA AND NON-HODGKIN LYMPHOMA NEEDING RADIATION THERAPY ON THYROID SITE

Studio randomizzato per proteggere da ipotiroidismo iatrogeno dovuto ad irradiazione pazienti con medulloblastoma (qualsiasi età, stadio e qualsiasi rischio biologico) e pazienti pediatrici con linfoma di Hodgkin e linfoma non-Hodgkin che necessitano di radioterapia includente la sede tiroidea

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

WIN-HYPO2021

A.4.1

Sponsor's protocol code number

WIN-HYPO2021

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 IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Istituto Nazionale dei Tumori
B.5.2	Functional name of contact point	SC Pediatria
B.5.3	Address:
B.5.3.1	Street Address	via Giacomo Venezian 1
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	0223902590
B.5.5	Fax number	0223902648
B.5.6	E-mail	luna.boschetti@istitutotumori.mi.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.2.1.2	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	Levotiroxina
D.3.2	Product code	[Levotiroxina]
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	LEVOTIROXINA
D.3.9.1	CAS number	51-48-9
D.3.9.2	Current sponsor code	Levotiroxina
D.3.9.3	Other descriptive name	levothyroxine
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOTIROXINA
D.3.9.1	CAS number	51-48-9
D.3.9.2	Current sponsor code	Levotiroxina
D.3.9.3	Other descriptive name	levothyroxine
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOTIROXINA
D.3.9.1	CAS number	51-48-9
D.3.9.2	Current sponsor code	Levotiroxina
D.3.9.3	Other descriptive name	levothyroxine
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOTIROXINA
D.3.9.1	CAS number	51-48-9
D.3.9.2	Current sponsor code	Levotiroxina
D.3.9.3	Other descriptive name	levothyroxine
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOTIROXINA
D.3.9.1	CAS number	51-48-9
D.3.9.2	Current sponsor code	Levotiroxina
D.3.9.3	Other descriptive name	levothyroxine
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOTIROXINA
D.3.9.1	CAS number	51-48-9
D.3.9.2	Current sponsor code	Levotiroxina
D.3.9.3	Other descriptive name	levothyroxine
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	Ormoni tiroidei

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

medulloblastoma, Hodgkin and non-Hodgkin lymphomas

medulloblastoma, linfomi di Hodgkin e linfomi non-Hodgkin

E.1.1.1

Medical condition in easily understood language

medulloblastoma, Hodgkin and non-Hodgkin lymphomas

medulloblastoma, linfomi di Hodgkin e linfomi non-Hodgkin

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10027107
E.1.2	Term	Medulloblastoma
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	22.0
E.1.2	Level	PT
E.1.2	Classification code	10029547
E.1.2	Term	Non-Hodgkin's lymphoma
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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10020206
E.1.2	Term	Hodgkin's disease
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate if the incidence of hypothyroidism after radiation therapy in medulloblastoma, Hodgkin and non-Hodgkin lymphomas can be reduced by TSH suppression during irradiation.

Valutare se l'incidenza dell'ipotiroidismo dopo radioterapia nel medulloblastoma, nei linfomi di Hodgkin e non-Hodgkin può essere ridotta dalla soppressione del TSH durante l'irradiazione.

E.2.2

Secondary objectives of the trial

Secondary objective will be the number and the type of parenchyma alterations after irradiation in all patients (both groups).

Obiettivo secondario sarà il numero e il tipo di alterazioni del parenchima dopo l'irradiazione in tutti i pazienti (entrambi i gruppi).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma BEFORE RADIOTHERAPY (RT) PLANNING INCLUDING THYROID PARENCHYMA without previous primary or secondary hypothyroidism;
2. Written informed consent prior to any study-specific analysis and/or data collection.

1. Qualsiasi paziente con medulloblastoma, linfoma di Hodgkin / non-Hodgkin PRIMA DELLA PIANIFICAZIONE DELLA RADIOTERAPIA (RT) CHE COMPRENDE IL PARENCHIMA TIROIDEO senza precedente ipotiroidismo primario o secondario;
2. Consenso informato scritto prima di qualsiasi analisi specifica dello studio e / o raccolta di dati.

E.4

Principal exclusion criteria

1. Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma;
2. Not signed consent.

1. Qualsiasi paziente con medulloblastoma, linfoma di Hodgkin / non-Hodgkin dopo radioterapia, che comprendeva il parenchima tiroideo;
2. Consenso non firmato.

E.5 End points

E.5.1

Primary end point(s)

Hypothyroidism-free survival at 3 years after radiotherapy including part or the whole thyroid parenchima on the intention-to-treat population will be the main end-point.
For both treatment groups (radiotherapy / radiotherapy + Levo-thyroxin), the analysis set will consist of patients evaluated with TSH blood dosage to evaluate the onset of hypothyroidism within three years from the radiotherapy beginning.

L'endpoint principale sarà la sopravvivenza libera da ipotiroidismo a 3 anni dopo la radioterapia, effettuata su una parte o sull'intero parenchima tiroideo nella gruppo intent-to-treat.
Per entrambi i gruppi di trattamento (radioterapia / radioterapia + levotiroxina), il set di analisi sarà costituito da pazienti valutati con dosaggio di TSH ematico per valutare l'insorgenza di ipotiroidismo entro tre anni dall'inizio della radioterapia.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 years from diagnosis

3 anni dalla diagnosi

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

E.6.4

Safety

E.6.5

Efficacy

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

Yes

E.6.13.1

Other scope of the trial description

To offer the possibility of a treatment that could achieve a meaningful reduction in the incidence of post-radiation therapy hypothyroidism

Offrire la possibilità di un trattamento che possa ottenere una significativa riduzione dell'incidenza di ipotiroidismo post-radioterapia

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

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

Yes

E.8.2.3.1

Comparator description

senza farmaco

without drug

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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)

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

oncology patients

pazienti oncologici

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 carry out normal follow-up required by their specific oncological clinical trial

i pazienti continueranno ad effettuare i normali controlli previsti dai piani di trattamento del loro tumore

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

2021-08-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-24

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

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