Clinical Trials Register

Summary
EudraCT Number:	2020-002336-74
Sponsor's Protocol Code Number:	SGN35-032
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:	2021-08-02
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-002336-74

A.3

Full title of the trial

A dual-cohort, open-label, phase 2 study of brentuximab vedotin and CHP (A+CHP) in the frontline treatment of subjects with peripheral T-cell
lymphoma (PTCL) with less than 10% CD30 expression

Studio a doppia coorte, in aperto, di fase 2 di brentuximab vedotin e CHP (A+CHP) nel trattamento di prima linea di soggetti con linfoma periferico a cellule T (peripheral T-cell lymphoma, PTCL) con espressione di CD30 inferiore al 10%

A.3.1

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

An open-label, phase 2 study of brentuximab vedotin and Chemotherapy agents in the frontline treatment of subjects with peripheral T-cell
lymphoma (PTCL)

Studio di fase 2 in aperto su brentuximab vedotin e agenti chemioterapici nel trattamento in prima linea di soggetti con linfociti T periferici
linfoma (PTCL)

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

SGN35-032

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	SEAGEN INC.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Seagen Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Seagen Inc.
B.5.2	Functional name of contact point	Seagen Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	21621- 30th Drive SE, Building 4
B.5.3.2	Town/ city	Bothell
B.5.3.3	Post code	98021
B.5.3.4	Country	United States
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	clinicaltrials@seagen.com

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	ADCETRIS®
D.2.1.1.2	Name of the Marketing Authorisation holder	Seattle Genetics, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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/3/08/596; EU/3/08/595
D.3 Description of the IMP
D.3.1	Product name	Brentuximab vedotin
D.3.2	Product code	[SGN-35]
D.3.4	Pharmaceutical form	Powder for concentrate for solution for 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	BRENTUXIMAB VEDOTIN
D.3.9.1	CAS number	914088-09-8
D.3.9.2	Current sponsor code	SGN-35
D.3.9.4	EV Substance Code	SUB32397
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	50
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)	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	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.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	Cyclophosphamide Injection
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter Healthcare Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	-
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder 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	CYCLOPHOSPHAMIDE MONOHYDRATE
D.3.9.1	CAS number	6055-19-2
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	CYCLOPHOSPHAMIDE MONOHYDRATE
D.3.9.4	EV Substance Code	SUB16414MIG
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: 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	Doxorubicin-Ebewe
D.2.1.1.2	Name of the Marketing Authorisation holder	EBEWE Pharma Ges.m.b.H. Nfg. KG
D.2.1.2	Country which granted the Marketing Authorisation	Austria
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	-
D.3.2	Product code	[-]
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	Doxorubicin Hydrochloride
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	Doxorubicin Hydrochloride
D.3.9.4	EV Substance Code	SUB01827MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	Prednison HEXAL®
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	-
D.3.2	Product code	[-]
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	PREDNISONE
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	PREDNISONE
D.3.9.4	EV Substance Code	SUB10020MIG
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	50
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

Non-sALCL PTCL and CD30 expression <10%

Espressione di PTCL e CD30 non sALCL <10%

E.1.1.1

Medical condition in easily understood language

T-cell Lymphoma

Linfoma a cellule T

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10034624
E.1.2	Term	Peripheral T-cell lymphoma unspecified NOS
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10034624
E.1.2	Term	Peripheral T-cell lymphoma unspecified NOS
E.1.2	System Organ Class	100000004864

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 the objective response rate (ORR) per blinded independent central review (BICR) using the Revised Response Criteria for Malignant
Lymphoma (Cheson 2007)

Valutare il tasso di risposta obiettiva (objective response rate, ORR) secondo la revisione centrale indipendente in cieco (blinded independent central review, BICR) utilizzando i Criteri di risposta modificati per il linfoma maligno (Cheson 2007)

E.2.2

Secondary objectives of the trial

- To evaluate the complete response (CR) following completion of study treatment (Cheson 2007)
- To evaluate progression-free survival (PFS) (Cheson 2007)
- To evaluate overall survival (OS)
- To evaluate duration of response (DOR) (Cheson 2007)
- To evaluate ORR per BICR using modified Lugano criteria (Cheson 2014)
- To evaluate safety and tolerability

- Valutare la risposta completa (complete response, CR) dopo il completamento del trattamento dello studio (Cheson 2007)
- Valutare la sopravvivenza libera da progressione (progression-free survival, PFS) (Cheson 2007)
- Valutare la sopravvivenza complessiva (overall survival, OS)
- Valutare la durata della risposta (duration of response, DOR) (Cheson 2007)
- Valutare l’ORR secondo BICR utilizzando i criteri modificati di Lugano (Cheson 2014)
- Valutare la sicurezza e la tollerabilità

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Age 18 years or older.
2.Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma
World Health Organization (WHO) 2016 classification.
3.The following non-sALCL PTCL subtypes are eligible:
a.PTCL – not otherwise specified (PTCL-NOS)
b.Angioimmunoblastic T-cell lymphoma (AITL)
c.Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1)
d.Enteropathy-associated T-cell lymphoma (EATL)
e.Hepatosplenic T-cell lymphoma
f.Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)
g.Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
h.Follicular T-cell lymphoma
i.Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype
4.CD30 expression <10% by local assessment
5.Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist.
6.An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Other protocol defined inclusion criteria may apply.

1. Età 18 anni o più.
2.PTCL di nuova diagnosi, escluso il linfoma anaplastico sistemico a grandi cellule (sALCL), secondo il linfoma europeo-americano rivisto
Classificazione 2016 dell'Organizzazione Mondiale della Sanità (OMS).
3.Sono idonei i seguenti sottotipi di PTCL non sALCL:
a. PTCL - non diversamente specificato (PTCL-NOS)
b. linfoma a cellule T angioimmunoblastico (AITL)
c. leucemia / linfoma a cellule T negli adulti (ATLL; solo tipi acuti e linfomi, devono essere positivi per il virus della leucemia a cellule T umane 1)
d. linfoma a cellule T associato a enteropatia (EATL)
e. Linfoma epatosplenico a cellule T
f. linfoma intestinale epiteliotropico monomorfico a cellule T (MEITCL)
g. disturbo linfoproliferativo a cellule T indolenti (T-LPD) del tratto gastrointestinale (GI)
h. linfoma a cellule T follicolari
i. linfoma a cellule T periferiche nodali con fenotipo T-follicular helper (TFH)
4. Espressione CD30 <10% in base alla valutazione locale
5.Fluorodesossiglucosio (FDG) -avid malattia da PET e malattia misurabile di almeno 1,5 cm da CT, come valutato dal radiologo del sito.
6.Un performance status dell'Eastern Cooperative Oncology Group (ECOG) inferiore o uguale a 2
Possono essere applicati altri criteri di inclusione definiti dal protocollo.

E.4

Principal exclusion criteria

1.Current diagnosis of any of the following:
a.sALCL
b.Primary cutaneous T-cell lymphoproliferative disorders and lymphomas
c.Mycosis fungoides (MF), including transformed MF
2.History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least
3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS >=90%), such as carcinoma in situ of the cervix,
non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
3.History of progressive multifocal leukoencephalopathy (PML).
4.Cerebral/meningeal disease related to the underlying malignancy.
5.Prior treatment with brentuximab vedotin or doxorubicin.
Other protocol defined exclusion criteria may apply.

1.Diagnosi attuale di uno dei seguenti:
a.sALCL
b. malattie linfoproliferative primarie cutanee a cellule T e linfomi
c. Micosi fungoide (MF), inclusa la MF trasformata
2.Storia di un altro tumore invasivo primario, neoplasia ematologica o sindrome mielodisplastica che non è stata in remissione per almeno
3 anni. Le eccezioni sono le neoplasie con un rischio trascurabile di metastasi o morte (ad esempio, OS a 5 anni >=90%), come il carcinoma in situ della cervice,
carcinoma cutaneo non melanoma, carcinoma prostatico localizzato, carcinoma duttale in situ o carcinoma uterino stadio I.
3. Storia di leucoencefalopatia multifocale progressiva (PML).
4. Malattia cerebrale / meningea correlata alla neoplasia sottostante.
5.Precedente trattamento con brentuximab vedotin o doxorubicina.
Possono essere applicati altri criteri di esclusione definiti dal protocollo.

E.5 End points

E.5.1

Primary end point(s)

ORR per BICR following the completion of study treatment using Revised Response Criteria for Malignant Lymphoma criteria (Cheson 2007)

ORR per BICR dopo il completamento del trattamento in studio utilizzando i criteri di risposta rivisti per i criteri del linfoma maligno (Cheson 2007)

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months after last subject enrolled

6 mesi dopo l'arruolamento ell'ultimo soggetto

E.5.2

Secondary end point(s)

- Complete response rate per BICR (Cheson 2007)
- PFS per BICR (Cheson 2007)
- Overall survival (OS)
- Duration of response (DOR) per BICR
- ORR per BICR, using modified Lugano criteria (Cheson 2014)
- Type, incidence, severity, seriousness, and relatedness of adverse events
- Laboratory abnormalities

- Tasso di risposta completo per BICR (Cheson 2007)
- PFS per BICR (Cheson 2007)
- Sopravvivenza globale (OS)
- Durata della risposta (DOR) per BICR
- ORR per BICR, utilizzando criteri Lugano modificati (Cheson 2014)
- Tipo, incidenza, gravità, gravità e correlazione degli eventi avversi
- Anomalie di laboratorio

E.5.2.1

Timepoint(s) of evaluation of this end point

- 1 year after last subject enrolled
- 1 year after last subject enrolled
- 1 year after last subject enrolled
- 1 year after last subject enrolled
- 1 year after last subject enrolled
- 1 year after last subject enrolled

- 1 anno dopo l'arruolamento dell'ultimo soggetto
- 1 anno dopo l'arruolamento dell'ultimo soggetto
- 1 anno dopo l'arruolamento dell'ultimo soggetto
- 1 anno dopo l'arruolamento dell'ultimo soggetto
- 1 anno dopo l'arruolamento dell'ultimo soggetto
- 1 anno dopo l'arruolamento dell'ultimo soggetto

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

Tolerability

Tollerabilità

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

United States

France

Italy

Spain

United Kingdom

Czechia

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

The study will be closed 2 years after enrollment of the last subject, or when no subjects remain in long-term follow-up, whichever occurs
first. Additionally, the sponsor may terminate the study at any time. The date the subject met criteria for study discontinuation and the reason for study discontinuation will be collected.

Lo studio verrà chiuso 2 anni dopo l'arruolamento dell'ultimo soggetto, o quando nessun soggetto rimane nel follow-up a lungo termine, a seconda di quale evento si verifichi primo. Inoltre, lo sponsor può interrompere lo studio in qualsiasi momento. Verranno raccolte la data in cui il soggetto ha soddisfatto i criteri per l'interruzione dello studio e il motivo dell'interruzione dello studio.

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)

No further treatment or ASCT for patients who achieve CR; salvage therapy or clinical trial for patients who don't respond or relapse

Nessun ulteriore trattamento o ASCT per i pazienti che ottengono CR; terapia di salvataggio o sperimentazione clinica per pazienti che non rispondono o hanno una ricaduta

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

2021-01-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-21

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials