Clinical Trials Register

Summary
EudraCT Number:	2015-001364-19
Sponsor's Protocol Code Number:	BO29563
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-03-07
Trial results	View 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

2015-001364-19

A.3

Full title of the trial

A phase Ib/II study evaluating the safety and efficacy of MPDL3280A in combination with either obinutuzumab plus bendamustine or obinutuzumab plus CHOP in patients with follicular lymphoma or diffuse large B-cell lymphoma

A.3.1

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

A Study of MPDL3280A plus Obinutuzumab and Bendamustine or Obinutuzumab and CHOP in Patients with Follicular Lymphoma or Diffuse
Large B-Cell Lymphoma

Uno studio su MPDL3280A in combinazione con obinutuzumab più bendamustina oppure obinutuzumab più CHOP in pazienti con linfoma follicolare o linfoma diffuso a grandi cellule B

A.3.2

Name or abbreviated title of the trial where available

A PHASE IB/II STUDY EVALUATING THE SAFETY AND EFFICACY OF MPDL3280A IN COMBINATION WITH EITHER OBINU

STUDIO DI FASE IB/II TESO PER VALUTARE LA SICUREZZA E L'EFFICACIA DI MPDL3280A IN COMBINAZIONE CON O

A.4.1

Sponsor's protocol code number

BO29563

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	F. HOFFMANN - LA ROCHE LTD.
B.1.3.4	Country	Switzerland
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	F.Hoffmann-La Roche Ltd
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	F.Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basilea
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0
B.5.5	Fax number	0
B.5.6	E-mail	global.rochegenentechtrials@roche.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	Gazyvaro
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited, UK
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	Yes
D.2.5.1	Orphan drug designation number	EU/3/14/1325
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Obinutuzumab
D.3.9.1	CAS number	949142-50-1
D.3.9.2	Current sponsor code	RO5072759
D.3.9.3	Other descriptive name	OBINUTUZUMAB/GA101
D.3.9.4	EV Substance Code	SUB32751
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	25
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	No
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	MPDL3280A
D.3.2	Product code	RO5541267/F03
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MPDL3280A
D.3.9.2	Current sponsor code	RO5541267
D.3.9.3	Other descriptive name	MPDL3280A
D.3.9.4	EV Substance Code	SUB126162
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	60
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	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	Levact®
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma GmbH
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.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BENDAMUSTINE HYDROCHLORIDE
D.3.9.1	CAS number	3543-75-7
D.3.9.2	Current sponsor code	RO5469113
D.3.9.4	EV Substance Code	SUB00696MIG
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	220
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	Agente antineoplastico, agente alchilante

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

Follicular lymphoma or diffuse large B-cell lymphoma

Linfoma follicolare o linfoma diffuso a grandi cellule B

E.1.1.1

Medical condition in easily understood language

Follicular lymphoma and diffuse large B-cell lymphoma are a type of cancer of the white blood cells (these cells are part of the body's immune system)

Il linfoma follicolare e il linfoma diffuso a grandi cellule B sono un tipo di cancro dei globuli bianchi (queste cellule fanno parte del sistema immunitario del corpo)

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	LLT
E.1.2	Classification code	10067070
E.1.2	Term	Follicular B-cell non-Hodgkin's lymphoma
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10016904
E.1.2	Term	Follicle centre lymphoma, follicular grade I, II, III NOS
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10012820
E.1.2	Term	Diffuse large B-cell lymphoma 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

• Safety: To evaluate the safety and tolerability
of induction treatment with either MPDL3280A in combination with obinutuzumab plus bendamustine (MPDL G benda) or MPDL3280A in combination with obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (MPDL-G-CHOP) and post-induction treatment with either
MPDL-G or MPDL3280A alone
• Efficacy: To evaluate the efficacy of induction treatment with either MPDL G benda or MPDL-G-CHOP

- Sicurezza: valutare la sicurezza e la tollerabilità del trattamento di induzione con MPDL3280A in
combinazione con obinutuzumab più bendamustina (MPDL-G-benda) o MPDL3280A in combinazione con obinutuzumab più ciclofosfamide, doxorubicina, vincristina e prednisone (MPDL-G-CHOP) e del trattamento di post-induzione con MPDL-G o
MPDL3280A in monoterapia
- Efficacia: valutare l'efficacia del trattamento di induzione con MPDL-G-benda o MPDL-G-CHOP

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of induction
treatment with either MPDL G benda or MPDL-G-CHOP and post-induction treatment with either MPDLG or MPDL3280A alone
• To characterize the pharmacokinetics of MPDL3280A and obinutuzumab when administered as induction treatment consisting of
either MPDL-G-benda or MPDL-G-CHOP, or post-induction treatment consisting of either MPDL-G or MPDL3280A alone
• To evaluate the immune response to obinutuzumab and to MPDL3280A

- valutare l'efficacia del trattamento di induzione con MPDL-G-benda o MPDL-G-CHOP e del
trattamento di post-induzione con MPDL-G o MPDL3280A in monoterapia
- valutare la farmacocinetica di MPDL3280A e obinutuzumab quando somministrati come trattamento di induzione costituito da
MPDL-G-benda o MPDL-G-CHOP o del trattamento di post-induzione costituito da MPDL-G o MPDL3280A in monoterapia
- valutare la risposta immunitaria a obinutuzumab e a MPDL3280A

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
• For patient enrolled in safety run-in phase: Relapsed or refractory follicular lymphoma after treatment with at least one prior
chemoimmunotherapy regimen or previously untreated Grade 1, 2, or 3a follicular lymphoma that requires treatment (as per Groupe d'Etudes des
Lymphomes Folliculaires (GELF) criteria)
• For patient enrolled in expansion phase: Previously untreated Grade 1, 2, or 3a follicular lymphoma that requires treatment (as
per GELF criteria) or previously untreated advanced diffuse large B-cell lymphoma (DLBCL)
• Histologically documented CD20-positive lymphoma
• Fluorodeoxyglucose-avid lymphoma (i.e., positron emission tomography -positive lymphoma)
• Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of
the diagnosis of FL or DLBCL
• For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of <1% per year during the treatment
period and for at least 18 months after the last dose of study treatment.
• For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm

•Età ≥ 18 anni
• Stato di validità ECOG (Eastern Cooperative Oncology Group) di 0, 1 o 2
• Per i pazienti arruolati nella fase di pre-trattamento sulla sicurezza: linfoma follicolare (FL) recidivante o refrattario dopo il trattamento con almeno un precedente regime di chemioimmunoterapia o linfoma follicolare di grado 1, 2 o 3a non trattato in
precedenza che richiede un trattamento, definito come FL che soddisfa almeno uno dei criteri del Groupe d'Etudes des Lymphomes Folliculaires (GELF)
• Per i pazienti arruolati nella fase di espansione: FL di grado 1, 2 o 3a non trattato in precedenza che richiede un trattamento (definito come FL che soddisfa almeno uno dei criteri GELF) o Linfoma Diffuso a Grandi Cellule B (DLBCL) in stadio avanzato non trattato in precedenza.
• Linfoma positivo per CD20 documentato mediante esame istologico
• Linfoma FDG avido (ossia linfoma positivo alla PET)
• Disponibilità di un campione tumorale rappresentativo e il corrispondente referto patologico per la conferma retrospettiva della
diagnosi di FL o DLBCL da parte del laboratorio centrale
•Le donne che non sono in post menopausa o chirurgicamente sterili devono: accettare di astenersi dai rapporti sessuali o usare
metodi contraccettivi che abbiano un tasso di insuccesso <1% all’anno durante il periodo di trattamento e per almeno 18 mesi
dopo l'ultima dose del trattamento in studio.
•Gli uomini devono: accettare di astenersi dai rapporti sessuali o usare metodi contraccettivi ed evitare di donare lo sperma

E.4

Principal exclusion criteria

• Histological evidence of transformation of follicular lymphoma into high-grade B-cell non-Hodgkin's lymphoma
• Central nervous system lymphoma or leptomeningeal infiltration
• For patients with relapsed or refractory FL (enrolled in the safety run-in
phase: Prior allogeneic or autologous stem cell transplantation; Prior anthracycline therapy
• History of solid organ transplantation
• History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies
• Active bacterial, viral, fungal, or other infection
• History of progressive multifocal leukoencephalopathy
• Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
• Known history of HIV positive status
• History of autoimmune disease

• Evidenza istologica di trasformazione del FL in NHL a cellule B di grado elevato
• Linfoma del sistema nervoso centrale o infiltrazione leptomeningea
• Per i pazienti con FL recidivante o refrattario (arruolati nella fase di pre-trattamento sulla sicurezza): Precedente trapianto
allogenico o autologo di cellule staminali; Precedente terapia con antraciclina
•Storia di trapianto di organi solidi
• Storia di grave reazione allergica o anafilattica ad anticorpi monoclonali umanizzati o murini
• Infezione attiva di natura batterica, virale, fungina o di altra natura
• Anamnesi di leucoencefalopatia multifocale progressiva
• Presenza di risultati positivi del test per l'antigene di superficie dell’epatite B (HBsAg), anticorpo anti-core dell’epatite B (HBcAb) totale o dell’anticorpo contro il virus dell’epatite C (HCV) allo screening
• Anamnesi nota di stato di sieropositività ad HIV
• Anamnesi di malattie autoimmuni

E.5 End points

E.5.1

Primary end point(s)

- Safety:
1. Nature, frequency, severity, and timing of adverse events
2. Changes in vital signs, ECGs, and clinical laboratory results during and
following study treatment administration

- Efficacy:
3. Complete response (CR) at end of induction (EOI) as determined by the Independent Review Committee (IRC) using Lugano 2014 criteria

- Sicurezza:
1. Natura, frequenza, gravità e momento di comparsa degli eventi avversi
2. Cambiamenti nei parametri vitali, nell'ECG e nei risultati degli esami clinici di laboratorio durante e dopo la somministrazione del trattamento dello studio

- Efficacia:
3. Risposta completa (CR) alla fine dell'induzione (EOI) secondo quanto determinato dal Comitato di revisione indipendente (IRC) utilizzando i criteri di Lugano 2014

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety:
1. Up to 35 days after the last dose of study treatment.
2. Up to 35 days after the last dose of study treatment.

Efficacy:
3. Efficacy: 6-8 weeks after Day 1 of the last cycle of induction treatment

- Sicurezza:
1. fino a 35 giorni dall'ultima dose del trattamento dello studio.
2. fino a 35 giorni dall'ultima dose del trattamento dello studio.

- Efficacia:
3.Efficacia: 6-8 settimane dopo il Giorno 1 dell'ultimo ciclo del trattamento di induzione

E.5.2

Secondary end point(s)

1. CR at EOI, as determined by the
investigator using Lugano 2014 criteria
2. CR at EOI, as determined by the IRC and by the investigator using modified Cheson 2007 criteria
3. Objective response (defined as a CR or partial response [PR]) at EOI, as determined by the IRC and by the investigator using Lugano 2014
criteria and modified Cheson 2007 criteria
4. Objective response (defined as a CR or PR) during the study, as determined by the investigator using modified Cheson 2007 criteria
5. Observed serum obinutuzumab concentration at specified timepoints
6. Observed serum MPDL3280A concentration at specified timepoints Immunogenicity
7. Incidence of human anti-human antibodies (HAHAs) to obinutuzumab during the study relative to the prevalence of HAHAs at baseline
8. Incidence of anti-therapeutic antibodies (ATAs) to MPDL3280A during the study relative to the prevalence of ATAs at baseline

1. CR a EOI, come determinato dallo sperimentatore utilizzando i criteri Lugano 2014
2. CR a EOI, come determinato dall'IRC e dallo sperimentatore utilizzando i criteri Cheson 2007 modificati
3. Risposta obiettiva (definita come CR o come risposta parziale [PR]) a EOI, come determinato dall'IRC e dallo sperimentatore
utilizzando i criteri Lugano 2014 e i criteri Cheson 2007 modificati
4. Risposta obiettiva (definita come CR o PR) durante lo studio, come determinato dallo sperimentatore utilizzando i criteri Cheson
2007 modificati
5. Concentrazione sierica di Obinutuzumab osservata in determinati momenti di valutazione
6. Concentrazione sierica di MPDL3280A osservata in determinati momenti di valutazione
Immunogenicità
7. Incidenza di anticorpi umani verso antigeni umani (HAHA) per Obinutuzumab durante lo studio in relazione alla prevalenza di HAHA al basale
8. Incidenza di anticorpi anti-terapia (ATA) per MPDL3280A durante lo studio in relazione alla prevalenza di ATA al basale

E.5.2.1

Timepoint(s) of evaluation of this end point

1-3. 6-8 wks after D1 of last induction phase cycle
4. Every 6 months after the induction phase until PD or EOT
5. D1-Cycles 1, 2 (MPDL-G-Benda) & D1-Cycles 1, 2, 5, 6/8 (MPDL-GCHOP) at pre-specified timepoints during post-induction, 120 days & 1 year after last GA101 dose
6. D1, D15-Cycles 2, 3, D15-Cycle 5 (MPDL-G-Benda) & D1-Cycles 2, 3, 5, 6/8 (MPDL-G-CHOP) at pre-specified timepoints during post-induction,
120 days & 1 year after last MPDL dose
7. D1-Cycle 1 (MPDL-G-Benda) & D1-Cycles 1, 5, 6/8 (MPDL-G-CHOP) at pre-specified timepoints during post-induction, 120 days & 1 year after
last GA101 dose
8. D1-Cycle 2, D1 & 15-Cycle 3, D15-Cycle 5 (MPDL-G-Benda) & D1-Cycles 2, 3, 5, 6/8 (MPDL-G-CHOP) at pre-specified timepoints during
post-induction, 120 days & 1 year after last MPDL dose

1-3. 6-8 settimane dopo il G1 dell'ultimo ciclo di fase di induzione
4. Ogni 6 mesi dopo la fase di induzione fino a PD o EOT
5. G1-Cicli 1 e 2 (MPDL-G-Benda) & G1-Cicli 1, 2, 5, 6/8 (MPDL-GCHOP) in momenti prestabiliti durante la post-induzione, 120 giorni e 1 anno dopo l'ultima dose di GA101
6. G1, G15-Cicli 2 e 3, G15-Ciclo 5 (MPDL-G-Benda) & G1-Cicli 2, 3, 5, 6/8 (MPDL-G-CHOP) in momenti prestabiliti durante la postinduzione,
120 giorni e 1 anno dopo l'ultima dose di MPDL
7. G1-Ciclo 1 (MPDL-G-Benda) & G1-Cicli 1, 5, 6/8 (MPDL-G-CHOP) in momenti prestabiliti durante la post-induzione, 120 giorni e 1 anno dopo l'ultima dose di GA101
8. G1-Ciclo 2, G1 e G15-Ciclo 3, G15-Ciclo 5 (MPDL-G-Benda) & G1-Cicli 2, 3, 5, 6/8 (MPDL-G-CHOP) in momenti prestabiliti durante la post-induzione, 120 gio

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

Yes

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)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Safety and efficacy

Sicurezza ed efficacia

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

Yes

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)

Yes

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.8.5.1

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

Australia

Italy

United States

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 end of this study is defined as the time when all enrolled FL patients have completed or discontinued study treatment and all enrolled DLBCL patients have been followed for at least 1 year after they have completed or discontinued study treatment

Si definisce "fine dello studio" il momento in cui tutti i pazienti con LF arruolati hanno completato o sospeso il trattamento dello studio e tutti i pazienti con DLBCL arruolati sono stati seguiti per almeno 1 anno da quando hanno completato o interrotto il
trattamento 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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

Yes

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

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)

Currently, the Sponsor does not have any plans to provide obinutuzumab, MPDL3280A, bendamustine, or any other study treatments or interventions to patients who have completed the study. The Sponsor will evaluate whether to continue providing obinutuzumab, MPDL3280A, or bendamustine in accordance with the
Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following Web site:
http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf

Al momento lo Sponsor non prevede di fornire Obinutuzumab, MPDL3280A, Bendamustina o qualsiasi altro trattamento o intervento dello studio ai pazienti che hanno completato lo studio. Lo Sponsor valuterà se continuare a fornire Obinutuzumab, MPDL3280A, o Bendamustina conformemente alla Politica globale di Roche sull'Accesso costante ai farmaci sperimentali (Continued Access to Investigational Medicinal Product), disponibile al seguente indirizzo:
http://www.roche.com/policy_continued_access_to_in

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

2015-11-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-12-15

P. End of Trial
P.	End of Trial Status	Completed

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:
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