Clinical Trials Register

Summary
EudraCT Number:	2020-005239-53
Sponsor's Protocol Code Number:	GO42909
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-07
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

Spain - AEMPS

A.2

EudraCT number

2020-005239-53

A.3

Full title of the trial

PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY

ESTUDIO DE FASE III ALEATORIZADO, ABIERTO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MOSUNETUZUMAB COMBINADO CON LENALIDOMIDA EN COMPARACIÓN CON RITUXIMAB COMBINADO CON LENALIDOMIDA EN PACIENTES CON LINFOMA FOLICULAR DESPUÉS DE AL MENOS UNA LÍNEA DE TRATAMIENTO SISTÉMICO

A.3.1

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

A Study to Evaluate Efficacy and Safety of Mosunetuzumab in Combination with Lenalidomide in Comparison to Rituximab in Combination with Lenalidomide in Patients with Follicular Lymphoma

Estudio para Evaluar la Eficacia y la Seguridad de Mosunetuzumab combinado con Lenalidomida en Comparación con Rituximab Combinado con Lenalidomida en Pacientes con Linfoma Folicular

A.4.1

Sponsor's protocol code number

GO42909

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	Roche Farma S. A. que realiza el ensayo en España y que actúa como representante 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. Hoffman-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	Basel
B.5.3.3	Post code	4047
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+34913257300
B.5.5	Fax number	+34913248196
B.5.6	E-mail	spain.start_up_unit@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	RoActemra®
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	RoActemra
D.3.2	Product code	RO4877533
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tocilizumab
D.3.9.1	CAS number	375823-41-9
D.3.9.2	Current sponsor code	RO4877533
D.3.9.4	EV Substance Code	SUB192077
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	20
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Revlimid
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe B.V., Utrecht, Netherlands
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Revlimid
D.3.2	Product code	RO6897771
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	5
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Comparator
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	MABTHERA/RITUXAN
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Mabthera
D.3.2	Product code	RO0452294
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITUXIMAB
D.3.9.1	CAS number	174722-31-7
D.3.9.2	Current sponsor code	RO452294
D.3.9.4	EV Substance Code	SUB12570MIG
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	10
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 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	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	Mosunetuzumab
D.3.2	Product code	RO7030816/F02-03
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MOSUNETUZUMAB
D.3.9.2	Current sponsor code	RO7030816
D.3.9.3	Other descriptive name	BTCT4465A, anti−CD20/CD3, anti−CD20/CD3 TDB antibody
D.3.9.4	EV Substance Code	SUB193314
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	1
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 5
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	Mosunetuzumab
D.3.2	Product code	RO7030816/F02-04
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MOSUNETUZUMAB
D.3.9.2	Current sponsor code	RO7030816
D.3.9.3	Other descriptive name	BTCT4465A, anti−CD20/CD3, anti−CD20/CD3 TDB antibody
D.3.9.4	EV Substance Code	SUB193314
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	1
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 6
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	Revlimid
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe B.V., Utrecht, Netherlands
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Revlimid
D.3.2	Product code	RO6897771
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	10
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 7
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	Revlimid
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe B.V., Utrecht, Netherlands
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Revlimid
D.3.2	Product code	RO6897771
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 8
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	Revlimid
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene Europe B.V., Utrecht, Netherlands
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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Revlimid
D.3.2	Product code	RO6897771
D.3.4	Pharmaceutical form	Capsule, hard
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	LENALIDOMIDE
D.3.9.1	CAS number	191732-72-6
D.3.9.4	EV Substance Code	SUB25389
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	20
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Relapsed/refractory follicular lymphoma

Linfoma folicular recidivante/resistente

E.1.1.1

Medical condition in easily understood language

Follicular lymphoma is a cancer that affects white blood cells called lymphocytes. The term relapsed or refractory indicates disease that grows again or does not respond to the treatment.

El linfoma folicular es un cáncer que afecta a los glóbulos blancos llamados linfocitos. El término recaída o refractaria indica una enfermedad que vuelve a crecer o no responde al tratamiento.

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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10016906
E.1.2	Term	Follicle centre lymphoma, follicular grade I, II, III refractory
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 the efficacy of mosunetuzumab in combination with lenalidomide (M+Len) compared with rituximab in combination with lenalidomide (R+Len) based on progression-free survival as determined by the independent review committee (IRC)

Evaluar la eficacia y la seguridad de mosunetuzumab en combinación con lenalidomida (M+Len) en comparación con rituximab en combinación con lenalidomida (R+Len) basado en la supervivencia libre de progresión determinado por un Comité de revisión independiente (IRC)

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of M+Len compared with R+Len based on progression-free survival as determined by the investigator, complete response rate as determined by the IRC and investigator, objective response rate as determined by the IRC and investigator, overall survival, duration of objective response, duration of complete response (CR), time to deterioration in physical functioning and fatigue and time to deterioration in lymphoma symptoms
To evaluate the safety of M+Len compared with R+Len
To characterize the pharmacokinetic (PK) profile of M+Len and R+Len
To evaluate the immune response to mosunetuzumab and rituximab

Evaluar la eficacia de M + Len en comparación con R + Len en función de la supervivencia libre de progresión determinada por el investigador, la tasa de respuesta completa determinada por el IRC y el investigador, la tasa de respuesta objetiva determinada por el IRC y el investigador, la supervivencia global, duración de la respuesta objetiva, duración de la respuesta completa (RC), tiempo hasta el deterioro del funcionamiento físico y fatiga y tiempo hasta el deterioro de los síntomas del linfoma
Evaluar la seguridad de M+Len en comparación con R+Len
Caracterizar el perfil farmacocinético (PK) de M+Len y R+Len
Evaluar la respuesta inmune al mosunetuzumab y rituximab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age >=18 years at the time of signing Informed Consent Form
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Histologically documented CD20 + follicular lymphoma (FL) (Grades 1-3a)
Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL
Adequate hematologic function (unless due to underlying lymphoma, per the investigator)
Normal laboratory values
Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program
Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use 2 adequate methods of contraception during the treatment period (including periods of treatment interruption), and for at least 28 days after the final dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab, and 12 months after the final dose of rituximab
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 28 days after the final dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab and 12 months after the final dose of rituximab
For patients enrolled in the extended China enrollment phase at National Medical Products Administration (NMPA)-recognized sites: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry

-Edad >=18 años en el momento de firmar el documento de consentimiento informado.
-Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0, 1 o 2.
- LF CD20 + documentado histológicamente (grados 1-3a)
- Necesidad de tratamiento sistémico según criterio del investigador basado en el tamaño del tumor y/o los criterios del Groupe d'Etude des Lymphomes Folliculaires
-Al menos un tratamiento sistémico previo para el linfoma, que incluyera una inmunoterapia o quimioinmunoterapia previa
- Disponibilidad de una muestra tumoral representativa y el correspondiente informe anatomopatológico en el momento de la recidiva/persistencia para confirmar el diagnóstico de LF.
- Función hematológica adecuada (a menos que se deba al linfoma subyacente, según el investigador)
-Valores analíticos normales
- Compromiso de cumplir todos los requisitos locales del plan de minimización de riesgos de lenalidomida, que incluye el programa mundial de prevención del embarazo.
- Mujeres con capacidad de procrear: Compromiso de practicar abstinencia sexual (abstenerse de mantener relaciones heterosexuales) o de utilizar dos métodos anticonceptivos adecuados, durante el período de tratamiento (incluidos los períodos de interrupción del tratamiento) y durante al menos 28 días después de la última dosis de lenalidomida, 3 meses después de la última dosis de tocilizumab (si procede) y mosunetuzumab y 12 meses después de la última dosis de rituximab.
- Varones: compromiso de mantener la abstinencia sexual (abstenerse de mantener relaciones heterosexuales) o de utilizar métodos anticonceptivos, así como de abstenerse de donar semen durante el período de tratamiento y durante, como mínimo, 28 días después de la última dosis de lenalidomida, 3 meses después de la última dosis de tocilizumab (si procede) y mosunetuzumab y 12 meses después de la última dosis de rituximab.
-En los pacientes incluidos en la fase ampliada de reclutamiento en China en centros reconocidos por la NMPA: el paciente reside actualmente en China continental, Hong Kong o Taiwán y es de ascendencia china.

E.4

Principal exclusion criteria

Grade 3b FL
History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
Active or history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
Prior standard or investigational anti-cancer therapy
Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=1 (per National Cancer Institute Common Toxicity Criteria for Adverse Events Version 5.0 [NCI CTCAE, v5.0]) prior to Day 1 of Cycle 1
Treatment with systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1
History of solid organ transplantation
History of severe allergic or anaphylactic reaction to humanized, chimeric or murine MAbs
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, lenalidomide, or thalidomide formulation, including mannitol
History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis
Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
Known or suspected chronic active Epstein-Barr virus (EBV) infection
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
Active Hepatitis B or C infection
Known history of human immunodeficiency virus (HIV) positive status
History of progressive multifocal leukoencephalopathy (PML)
Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
Other malignancy that could affect compliance with the protocol or interpretation of results
Active autoimmune disease requiring treatment
History of autoimmune disease
Prior allogeneic stem cell transplant (SCT)
Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease or significant pulmonary disease
Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study
Pregnant or lactating or intending to become pregnant during the study
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment

-LF de grado 3b.
-Antecedentes de transformación de enfermedad poco activa en linfoma difuso de células B grandes.
-Resistencia documentada a la lenalidomida, definida como ausencia de respuesta (respuesta parcial o respuesta completa) o recidiva en los 6 meses siguientes al tratamiento.
-Presencia o antecedentes de linfoma en el SNC o infiltración leptomeníngea.
-Tratamiento antineoplásico previo, convencional o experimental
-Toxicidad clínicamente significativa (distinta de la alopecia) del tratamiento previo que no se ha resuelto a un grado <= 1 (según los Criterios terminológicos comunes para acontecimientos adversos del National Cancer Institute, versión 5.0) antes del día 1 del ciclo 1.
-Tratamiento con inmunodepresores sistémicos en las 2 semanas previas al día 1 del ciclo 1.
-Antecedentes de trasplante de órgano sólido.
-Antecedentes de reacciones alérgicas o anafilácticas graves a anticuerpos monoclonales humanizados, quiméricos o murinos.
-Hipersensibilidad conocida a biofármacos producidos en células de ovario de hámster chino o a cualquiera de los componentes de la formulación de mosunetuzumab, lenalidomida o talidomida, incluido el manitol.
-Antecedentes de eritema multiforme, exantema de grado >= 3 o formación de ampollas después del tratamiento previo con derivados inmunomoduladores.
-Antecedentes de enfermedad pulmonar intersticial, neumonitis inducida por fármacos y neumonitis autoinmune
-Infección activa conocida por bacterias, virus, hongos u otros microorganismos o cualquier episodio importante de infección con necesidad de tratamiento con antibióticos IV en las 4 semanas previas al día 1 del ciclo 1.
-Confirmación o sospecha de infección activa crónica por el virus de Epstein-Barr (VEB).
-Antecedentes conocidos o sospecha de linfohistiocitosis hemofagocítica (LHH).
-Antecedentes clínicamente significativos de enfermedad hepática, como hepatitis vírica o de otro tipo, o cirrosis.
-Infección por hepatitis B o C activa.
-Antecedentes de positividad para el VIH.
Antecedentes de leucoencefalopatía multifocal progresiva (LMP).
-Administración de una vacuna de microorganismos vivos, atenuados en las 4 semanas previas a la primera dosis del tratamiento del estudio o previsión de la necesidad de una vacuna de ese tipo durante el estudio.
-Otra neoplasia maligna que pueda afectar al cumplimiento del protocolo o a la interpretación de los resultados
-Enfermedad autoinmunitaria activa con necesidad de tratamiento
-Antecedentes de enfermedad autoinmunitaria
-Trasplante alogénico previo de células madre
-Indicios de enfermedad concomitante, no controlada y significativa que pueda afectar al cumplimiento del protocolo o a la interpretación de los resultados, tales como enfermedad cardiovascular importante o enfermedad pulmonar importante
-Intervención de cirugía mayor, aparte de las realizadas con fines diagnósticos, en los 28 días previos al día 1 del ciclo 1 o previsión de la necesidad de una intervención de este tipo durante el estudio
-Mujer embarazada, en período de lactancia o con intención de quedarse embarazada durante el estudio
-Cualquier enfermedad grave o anomalía analítica, en opinión del investigador

E.5 End points

E.5.1

Primary end point(s)

Progression-free survival as determined by the IRC with use of the 2014 Lugano Response Criteria or death from any cause in the intent-to-treat (ITT) population

Supervivencia libre de progresión determinado por el Comité de Revisión Independiente (IRC) utilizando los criterios de respuesta de Lugano de 2014 o muerte por cualquier causa en la población por intención de tratar (ITT)

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to approximately 8 years

Hasta aproximadamente 8 años

E.5.2

Secondary end point(s)

• Progression-free survival as determined by the investigator in the ITT population
• Complete response rate in the ITT population as determined by the IRC and investigator
• Objective response rate in the ITT population as determined by the IRC and investigator
• Overall survival in the ITT population
• Duration of objective response (DOR)
• Duration of CR
• Time to deterioration in physical functioning and fatigue, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
• Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)
• Incidence and severity of adverse events, with severity determined according to the NCI CTCAE, v5.0, including cytokine release syndrome (CRS), with severity determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS grading criteria
• Change from baseline in targeted vital signs
• Change from baseline in targeted clinical laboratory test results
• Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events
• Minimum observed concentration (Cmin) of Mosunetuzumab
• Cmin of Lenalidomide
• Maximum observed concentration (Cmax) of Mosunetuzumab
• Cmax of Lenalidomide
• Area under the concentration-time curve (AUC) of Mosunetuzumab
• AUC of Lenalidomide
• Prevalence of anti-drug antibodies (ADAs) against mosunetuzumab at baseline
• Prevalence of ADAs against rituximab at baseline
• Incidence of ADAs against mosunetuzumab during the study
• Incidence of ADAs against rituximab during the study
• Cmin of Rituximab
• Cmax of Rituximab
• AUC of Rituximab

• Supervivencia libre de progresión determinada por el investigador en la población ITT
• Tasa de respuesta completa en la población ITT según lo determinado por el IRC y el investigador
• Tasa de respuesta objetiva en la población ITT determinada por el IRC y el investigador
• Supervivencia global en la población ITT
• Duración de la respuesta objetiva (DRO)
• Duración de la RC
• Tiempo transcurrido hasta el deterioro del funcionamiento físico y la fatiga, según lo medido por el Cuestionario 30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer de Calidad de Vida (EORTC QLQ-C30)
• Tiempo hasta el deterioro de los síntomas del linfoma, medido por la subescala de evaluación funcional de la terapia del cáncer y linfoma (FACT-LymS)
• Incidencia y gravedad de los eventos adversos, con gravedad determinada según el NCI CTCAE, v5.0, incluido el síndrome de liberación de citoquinas (SLC), con gravedad determinada según los criterios de clasificación de SLC de la Sociedad Americana de Trasplantes y Terapia Celular (ASTCT)
• Cambio desde el momento basal en los signos vitales específicos
• Cambio con respecto al momento basal en los resultados de las pruebas clínicas de laboratorio específicas
• Tolerabilidad, evaluada por interrupciones de dosis, reducciones de dosis e intensidad de dosis, y suspensión del tratamiento del estudio debido a eventos adversos.
• Concentración mínima observada (Cmin) de Mosunetuzumab
• Cmin de lenalidomida
• Concentración máxima observada (Cmax) de Mosunetuzumab
• Cmáx de lenalidomida
• Área bajo la curva de concentración-tiempo (AUC) de Mosunetuzumab
• AUC de lenalidomida
• Prevalencia de anticuerpos antidrogas (ADA) contra mosunetuzumab al inicio del estudio
• Prevalencia de ADA contra rituximab al inicio del estudio
• Incidencia de ADA contra mosunetuzumab durante el estudio
• Incidencia de ADA contra rituximab durante el estudio
• Cmin de rituximab
• Cmáx de rituximab
• AUC de rituximab

E.5.2.1

Timepoint(s) of evaluation of this end point

1-9. Up to approximately 8 years
10-11. Baseline to 8 years
12. Up to approximately 8 years
13. Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2 to 12
14. Day 1 of Cycles 2 to 11
15. Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2 to 12
16. Day 1 of Cycles 2 to 11
17. Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2 to 12
18. Day 1 of Cycles 2 to 11
19-20. At Baseline
21-22. Up to approximately 8 years
23-25. Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2 to 11

1-9. Hasta aproximadamente 8 años
10-11. momento basal a 8 años
12. Hasta aproximadamente 8 años
13. Días 1, 8 y 15 del ciclo 1, día 1 de los ciclos 2 a 12
14. Día 1 de los ciclos 2 a 11
15. Días 1, 8 y 15 del ciclo 1, día 1 de los ciclos 2 a 12
16. Día 1 de los ciclos 2 a 11
17. Días 1, 8 y 15 del ciclo 1, día 1 de los ciclos 2 a 12
18. Día 1 de los ciclos 2 a 11
19-20. En momento basal
21-22. Hasta aproximadamente 8 años
23-25. Días 1, 8 y 15 del ciclo 1, día 1 de los ciclos 2 a 11

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

Yes

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)

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

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

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)

Information not present in EudraCT

E.8.2.2

Placebo

E.8.2.3

Other

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

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

Brazil

China

Japan

Korea, Republic of

Russian Federation

Taiwan

Turkey

Ukraine

United States

France

Germany

Italy

Poland

Spain

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

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 date when the last patient, last visit, occurs (i.e., last
patient in the global and extended China enrollment phases combined) or the date at which the
last data point required for statistical analysis or safety follow-up is received from the last patient
(global and extended China enrollment phases combined), whichever occurs later.
In addition, the Sponsor may decide to terminate the study at any time.

Fecha en que tenga lugar la última visita del último paciente (último paciente de la fase de reclutamiento mundial y la fase ampliada de reclutamiento en China combinadas) o la fecha en la que se reciban los últimos datos necesarios para el análisis estadístico o el seguimiento de seguridad último paciente (fase de reclutamiento mundial y fase ampliada de reclutamiento en China combinadas), lo que ocurra más tarde. Además, el promotor puede decidir finalizar el estudio en cualquier momento.

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

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:

220

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

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

150

F.4.2.2

In the whole clinical trial

400

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 Roche IMPs (mosunetuzumab, rituximab, tocilizumab) or any other study treatments to patients who have completed the study. The Sponsor may evaluate whether to continue providing mosunetuzumab, rituximab, and tocilizumab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product

Actualmente, el Promotor no tiene planes de proporcionar los IMP de Roche (mosunetuzumab, rituximab, tocilizumab) ni ningún otro tratamiento del estudio a los participantes que hayan completado el estudio. El Promotor puede evaluar si continúa proporcionando mosunetuzumab, rituximab y tocilizumab de acuerdo con la Política global de Roche sobre acceso continuo a medicamentos en investigación

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	LYSARC
G.4.3.4	Network Country	France
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	GLA
G.4.3.4	Network Country	Germany

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-09-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-06

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

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Select Trial Status:	Select Trial Phase:
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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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