Clinical Trials Register

Summary
EudraCT Number:	2019-004566-17
Sponsor's Protocol Code Number:	EORTC-1820-CLTF
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
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

2019-004566-17

A.3

Full title of the trial

Open-Label, phase II, Multi-Center, study of Anti-CCR4 Monoclonal Antibody (mogamulizumab) Plus Total Skin Electron Beam therapy (TSEB) in patients with stage IB-IIB Cutaneous T-Cell Lymphoma

Studio in aperto, di fase II, multicentrico con anticorpo monoclonale anti-CCR4 (mogamulizumab) in associazione a TSEB (total skin electron beam) in pazienti con linfoma cutaneo a cellule T in stadio IB-IIB (MOGAT)

A.3.1

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

Phase II study of a monoclonal antibody, mogamulizumab, associated with radiotherapy called total skin electron beam (TSEB), in patients with cutaneous T-cell lymphoma

Studio di fase II di un anticorpo monoclonale, mogamulizumab, associato a una forma di radioterapia denominata terapia a fascio elettronico totale (TSEB) in pazienti con linfoma cutaneo a cellule T

A.3.2

Name or abbreviated title of the trial where available

MOGAT

A.4.1

Sponsor's protocol code number

EORTC-1820-CLTF

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04128072

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	EORTC AISBL/IVZW
B.1.3.4	Country	Belgium
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	European Organisation for the Research and Treatment of Cancer
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	Kyowa Kirin
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	European Organisation for the Research and Treatment of Cancer
B.5.2	Functional name of contact point	Regulatory Affairs Department
B.5.3	Address:
B.5.3.1	Street Address	83/11 Avenue E. Mounier
B.5.3.2	Town/ city	Brussels
B.5.3.3	Post code	1200
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+3227741346
B.5.5	Fax number	+3227727063
B.5.6	E-mail	regulatory@eortc.org

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	POTELIGEO
D.2.1.1.2	Name of the Marketing Authorisation holder	Kyowa Kirin Holdings B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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/3/16/1756
D.3 Description of the IMP
D.3.1	Product name	KW-0761 (Mogamulizumab)
D.3.2	Product code	[KW-0761]
D.3.4	Pharmaceutical form	Concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Mogamulizumab
D.3.9.1	CAS number	1159266-37-1
D.3.9.2	Current sponsor code	KW-0761
D.3.9.3	Other descriptive name	MOGAMULIZUMAB
D.3.9.4	EV Substance Code	SUB85518
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
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

Cutaneous T-cell lymphoma (Mycosis Fungoides (MF) and Sézary Syndrome (SS))

Linfoma cutaneo a cellule T (Micosi fungoide (MF) e Sézary Sindrome (SS))

E.1.1.1

Medical condition in easily understood language

Cutaneous T-cell lymphoma, a category of cancers of lymphocytes (a type of white blood cells) that primarily involve the skin

Linfoma cutaneo a cellule T, una categoria di tumori dei linfociti (un tipo di globuli bianchi) che coinvolgono principalmente la pelle

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

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 evaluate the progression free survival rate at 48 weeks (according to EORTC-ISCL-USCLC criteria) of anti-CCR4 monoclonal antibody (mogamulizumab) and TSEB in IB-IIB cutaneous T-cell lymphoma.

Valutare il tasso di sopravvivenza libera da progressione a 48 settimane (secondo i criteri EORTC-ISCL-USCLC) dell’anticorpo monoclonale anti-CCR4 (mogamulizumab) e della TSEB nel linfoma cutaneo a cellule T IB-IIB.

E.2.2

Secondary objectives of the trial

• To evaluate the overall safety
• To assess the response rate
• To assess the progression-free survival
• To assess the overall survival
• To assess the time to progression
• To evaluate the duration of response
• To evaluate the time to next significant treatment

• Valutare la il profilo di sicurezza e tollerabilità complessivi
• Valutare il tasso di risposta
• Valutare la sopravvivenza libera da progressione
• Valutare la sopravvivenza complessiva
• Valutare il tempo alla progressione
• Valutare la durata della risposta
• Valutare il tempo al successivo trattamento significativo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Males and female subjects = 18 years;
• Mycosis fungoides stage IB, IIA, IIB;
• Subjects who have failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy;
• Adequate haematological and organ function;
• Signed informed consent

• Soggetti di sesso maschile e femminile di età =18 anni;
• Micosi fungoide in stadio IB, IIA, IIB;
• Soggetti che non hanno risposto ad almeno un precedente ciclo di terapia sistemica. Il trattamento con psoralene più terapia con luce ultravioletta (PUVA) non è considerato una terapia sistemica;
• Adeguata funzionalità ematologica e d’organo;
• Consenso informato firmato

E.4

Principal exclusion criteria

• Prior treatment with mogamulizumab;
• Prior TSEB

• Precedente trattamento con mogamulizumab
• Precedente TSEB

E.5 End points

E.5.1

Primary end point(s)

Progression Free Survival Rate at 48 weeks (PFSR-48)

Tasso di sopravvivenza libera da progressione a 48 settimane (PFSR-48)

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 48 weeks after start of mogamulizumab for each patient

Fino a 48 settimane dopo l’inizio della terapia con mogamulizumab per ciascun paziente

E.5.2

Secondary end point(s)

• Overall safety of both mogamulizumab and TSEB;
• Response rate (RR) to both mogamulizumab and TSEB ;
• Progression-free survival (PFS) ;
• Overall survival (OS);
• Time to progression ;
• Duration of response ;
• Time to next treatment.

Exploratory endpoints:
Quality of life: Skindex-29 and EORTC-QLQ-C30, and time to treatment failure.

• Sicurezza complessiva di mogamulizumab e della TSEB;
• Tasso di risposta sia a mogamulizumab sia alla TSEB (TR);
• Sopravvivenza libera da progressione (SLP);
• Sopravvivenza complessiva (SC);
• Tempo alla progressione (TP);
• Durata della risposta;
• Tempo al trattamento successivo.

E.5.2.1

Timepoint(s) of evaluation of this end point

• Overall safety: 48 months after last patient in;
• RR: from the first patient treatment start till 48 weeks as of last patient in;
• PFS: from the first patient treatment start till 48 weeks as of last patient in;
• OS: from the first patient treatment start till 5 years after last patient treatment;
• Time to progression: from the first patient treatment start till 48 weeks as of last patient in;
• Duration of resp: from the first patient treatment start till 48 weeks as of last patient in;
• Time to next treatment: from the first patient treatment start till 48 weeks as of last patient in.

• Sicurezza complessiva: 48 mesi dopo l’inclusione dell’ultimo paziente;
• TR: Dall’inizio del trattamento del primo paziente fino a 48 settimane dopo l’inclusione dell’ultimo paziente;
• SLP: Dall’inizio del trattamento del primo paziente fino a 48 settimane dopo l’inclusione dell’ultimo paziente;
• SC: Dall’inizio del trattamento del primo paziente fino a 5 anni dopo il trattamento dell’ultimo paziente;
• TP: Dall’inizio del trattamento del primo paziente fino a 48 settimane dopo l’inclusione dell’ultimo paziente;
• Durata della risposta: Dall’inizio del trattamento del primo paziente fino a 48 settimane dopo l’inclusione dell’ultimo paziente;
• Tempo al trattamento successivo: Dall’inizio del trattamento del primo paziente fino a 48 settimane dopo l’inclusione dell’ultimo paziente

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

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

Yes

E.6.13.1

Other scope of the trial description

Radiotherapy, Biobanking, Quality of Life

Radioterapia, Biobanca, qualità della vita

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

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

Finland

France

Germany

Italy

Spain

United Kingdom

Greece

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

End of study occurs when all of the following criteria have been satisfied:
1. Ninety days after all patients have stopped protocol treatment
2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
3. The database has been fully cleaned and frozen for this analysis

La fine dello studio si verifica quando tutti i seguenti criteri sono stati
soddisfatti:
1. Trenta giorni dopo che tutti i pazienti hanno interrotto il trattamento con protocollo
2. La sperimentazione è matura per l'analisi dell'endpoint primario come definito nel protocollo
3. Il database è stato completamente pulito e congelato per questa analisi.

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)

After progression, the treatment will be left to the discretion of the treating physician

A discrezione del medico curante

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

2021-08-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-11-08

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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