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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001141-13
    Sponsor's Protocol Code Number:GO40516
    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:2021-08-25
    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.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-001141-13
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICENTER, PHASE Ib/II TRIAL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA
    Estudio de fase Ib/II, abierto y multicéntrico para evaluar la seguridad, la tolerabilidad, la farmacocinética y la eficacia de mosunetuzumab (BTCT4465A) en combinación con polatuzumab vedotin en pacientes con linfoma no hodgkiniano de linfocitos B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in Patients with B-Cell Non-Hodgkin Lymphoma
    Estudio para evaluar la seguridad, la tolerabilidad, la farmacocinética y la eficacia de mosunetuzumab (BTCT4465A) en combinación con polatuzumab vedotin en pacientes con linfoma no hodgkiniano de linfocitos B
    A.4.1Sponsor's protocol code numberGO40516
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03671018
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248196
    B.5.6E-mailspain.start_up_unit@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMosunetuzumab
    D.3.2Product code RO7030816/F02-01
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOSUNETUZUMAB
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeRO7030816
    D.3.9.3Other descriptive nameBTCT4465A, anti−CD20/CD3, anti−CD20/CD3 TDB antibody
    D.3.9.4EV Substance CodeSUB193314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMosunetuzumab is a humanized bispecific antibody composed of an anti-CD20 half-antibody and an anti-CD3 half-antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2013
    D.3 Description of the IMP
    D.3.1Product namePolatuzumab vedotin
    D.3.2Product code RO5541077/F02-02
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLATUZUMAB VEDOTIN
    D.3.9.1CAS number 1313206-42-6
    D.3.9.2Current sponsor codeRO5541077
    D.3.9.3Other descriptive nameDCDS4501A/DCDS4501S
    D.3.9.4EV Substance CodeSUB177827
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH, Germany
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeRO4877533
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Polivy
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH, Germany
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2013
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLATUZUMAB VEDOTIN
    D.3.9.1CAS number 1313206-42-6
    D.3.9.2Current sponsor codeRO5541077
    D.3.9.3Other descriptive nameDCDS4501A/DCDS4501S
    D.3.9.4EV Substance CodeSUB177827
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMosunetuzumab
    D.3.2Product code RO7030816/F02-03
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOSUNETUZUMAB
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeRO7030816
    D.3.9.3Other descriptive nameBTCT4465A, anti−CD20/CD3, anti−CD20/CD3 TDB antibody
    D.3.9.4EV Substance CodeSUB193314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMosunetuzumab is a humanized bispecific antibody composed of an anti-CD20 half-antibody and an anti-CD3 half-antibody
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMosunetuzumab
    D.3.2Product code RO7030816/F02-04
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOSUNETUZUMAB
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeRO7030816
    D.3.9.3Other descriptive nameBTCT4465A, anti−CD20/CD3, anti−CD20/CD3 TDB antibody
    D.3.9.4EV Substance CodeSUB193314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMosunetuzumab is a humanized bispecific antibody composed of an anti-CD20 half-antibody and an anti-CD3 half-antibody
    D.IMP: 7
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMosunetuzumab
    D.3.2Product code RO7030816/F05-02
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOSUNETUZUMAB
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeRO7030816
    D.3.9.3Other descriptive nameBTCT4465A, anti−CD20/CD3, anti−CD20/CD3 TDB antibody
    D.3.9.4EV Substance CodeSUB193314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMosunetuzumab is a humanized bispecific antibody composed of an anti-CD20 half-antibody and an anti-CD3 half-antibody
    D.IMP: 8
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMosunetuzumab
    D.3.2Product code RO7030816/F03-01
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMOSUNETUZUMAB
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeRO7030816
    D.3.9.3Other descriptive nameBTCT4465A, anti−CD20/CD3, anti−CD20/CD3 TDB antibody
    D.3.9.4EV Substance CodeSUB193314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMosunetuzumab is a humanized bispecific antibody composed of an anti-CD20 half-antibody and an anti-CD3 half-antibody
    D.IMP: 9
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH, Germany
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code Ro 045-2294/V02-02
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRituximab
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRO0452294
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    B-cell non-Hodgkin lymphoma (NHL)
    linfoma no hodgkiniano de linfocitos B
    E.1.1.1Medical condition in easily understood language
    B-cell NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) & mantle cell lymphoma (MCL) as subtypes, is a type of cancer that forms in B-cells (a type of immune system cell)
    El LNH de células B, incluido el L difuso de cél B grandes (DLBCL), el L folicular (FL) y el L de cél del manto (MCL) como subtipos, es un tipo de cáncer q se forma en las células B(cél sist inmuno)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10067070
    E.1.2Term Follicular B-cell non-Hodgkin's lymphoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012820
    E.1.2Term Diffuse large B-cell lymphoma NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10012856
    E.1.2Term Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10023768
    E.1.2Term Large cell immunoblastic lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10012857
    E.1.2Term Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10023769
    E.1.2Term Large cell immunoblastic lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase Ib
    • To evaluate the safety and tolerability of mosunetuzumab (Mosun) + polatuzumab vedotin (Pola) in patients with relapsed or refractory (R/R) DLBCL or follicular lymphoma (FL), including estimation of maximum tolerated dose, determination of recommended Phase II dose (RP2D), characterization of dose-limiting toxicity (DLT)
    • To make a preliminary assessment of the anti-tumor activity of Mosun + Pola
    Phase II:
    • To evaluate the efficacy of Mosun (IV) plus Pola in patients with R/R FL and R/R DLBCL, based on best objective response rate (ORR) in the study, as determined by the Independent Review Committee (IRC)
    • To evaluate the efficacy of Mosun (SC) plus Pola in patients with R/R DLBCL and R/R MCL based on best ORR in the study, as determined by the Independent Review Committee (IRC)
    Fase Ib
    •Evaluar la seguridad y la tolerabilidad de mosunetuzumab (Mosun) más polatuzumab vedotin (Pola) en pacientes con LF o LDLBG R/R, lo que abarca la estimación de la DMT, la determinación de la DRF2 y la caracterización de las TLD
    •Realizar una evaluación preliminar de la actividad antineoplásica de Mosun + Pola
    Fase II:
    •Evaluar la eficacia de Mosun i.v. más Pola en pacientes con LF R/R y LDLBG R/R basado en Mejor Tasa de Respuesta Objetiva (TRO) en el estudio, determinada por el Comité de Revisión Independiente (CRI)
    •Evaluar la eficacia de Mosunetuzumab s.c. más Pola en en pacientes con LCM R/R y LDLBG R/R basado en TRO en el estudio, determinada por el Comité de Revisión Independiente (CRI)
    E.2.2Secondary objectives of the trial
    Phase Ib and II
    • To characterize the pharmacokinetics of Mosun (SC and IV) as a single agent and when administered in combination with Pola
    • To assess the incidence of anti-drug antibodies (ADAs) to Mosun and Pola
    Phase II
    • To evaluate the efficacy of Mosun + Pola in R/R DLBCL (Mosun SC and IV), R/R FL (Mosun IV), and R/R MCL (Mosun SC), based on best ORR as determined by the investigator; best complete response (CR) rate; CR rate by at primary response assessment (PRA); ORR at PRA; duration of response (DOR); progression-free survival (PFS); event-free survival (EFS) and overall survival (OS)
    • To evaluate the safety of Mosun + Pola in R/R DLBCL (Mosun SC and IV), R/R FL (Mosun IV), and R/R MCL (Mosun SC)
    Fase Ib y II
    •Caracterizar la farmacocinética de Mosun (s.c. e i.v.) como agente simple o cuando se administra en combinación con Pola
    •Evaluar la incidencia de anticuerpo antifármaco (AAF) para Mosu y Pola
    Fase II
    •Evaluar la eficacia de Mosun + pola en LDLBG R/R (Mosu s.c. e i.v.), LF R/R (Mosun i.v.) y LCM R/R /(Mosun s.c), basado en mejor TRO determinada por el investigador, Mejor Tasa de respuesta completa (RC), mejor Tasa de RC en evaluación de la respuesta primaria (ERP), TRO en ERP, Duración de respuesta (DdR), supervivencia sin progresión (SSP), supervivencia sin complicaciones (SSC) y supervivencia Global (SG)
    •Evaluar la seguridad de Mosun + Pola en LDLBG R/R (Mosu s.c. e i.v.), LF R/R (Mosun i.v.) y LCM R/R /(Mosun s.c)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - Able to comply with the study protocol and procedures in the investigator’s judgment
    - Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
    - Life expectancy of at least 12 weeks 

    - Patients must have histologically confirmed FL or DLBCL or MCL
    - For DLBCL or FL, must have received at least one prior systemic treatment regimen containing an anti- cluster of differentiation 20 (CD20) - directed therapy
    - For MCL, must have received at least two prior systemic treatment regimens which include agents from all three classes below: anti-CD20-directed therapy, a Bruton’s tyrosine kinase (BTK) inhibitor, and an anthracycline or bendamustine
    - Adequate hepatic, hematologic and renal function
    -Edad ≥ 18 años
    -Capacidad para cumplir el protocolo y los procedimientos del estudio a juicio del investigador
    -EF ECOG de 0, 1 o 2
    -Esperanza de vida de al menos 12 semanas
    - Los pacientes deben presentar LF, LDLBG o LCM confirmados histológicamente
    -Para LDLBG o LF: Debe haber recibido al menos una pauta de tratamiento sistémica anterior que contenga un tratamiento anti-CD20 dirigido.
    -Para LCM: Debe haber recibido al menos dos tratamientos sistémicos previos, que incluyan fármacos de las tres clases siguientes: Tratamiento anti-CD20 dirigido, Inhibidor de la BTK o Antraciclina o bendamustina
    - Adecuada función hepática, hematológica y renal
    E.4Principal exclusion criteria
    - Inability to comply with protocol-mandated hospitalization and activity restrictions
    - Pregnant or lactating women
    - Prior treatment with Mosun or other CD20-directed bispecific antibodies or with Pola
    - Current > Grade 1 peripheral neuropathy
    - Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate chemotherapy, or other investigational anti-cancer agent within 4 weeks before first dose of study treatment
    - Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
    - Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration, or any prior allogeneic SCT or solid organ transplantation
    - Prior treatment with chimeric antigen receptor -T therapy within 30 days before first study treatment administration
    - Current or past history of central nervous system (CNS) lymphoma and of CNS disease
    - Significant cardiovascular disease or pulmonary disease
    - Recent major surgery within 4 weeks prior to first study treatment administration
    - Hepatitis B or C or human immunodeficiency virus (HIV)
    - Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
    - History of autoimmune disease (stable autoimmune diseases may be eligible)
    - Systemic immunosuppressive medication within 2 weeks prior to study drug
    - Incapacidad para cumplir la hospitalización y las restricciones de las actividades estipuladas en el protocolo
    -Mujeres embarazadas o en período de lactancia
    - Tratamiento previo con Mosun u otros anticuerpos biespecíficos dirigidos contra CD20 o con Pola
    -Neuropatía periférica en curso de grado > 1
    -Uso anterior de cualquier anticuerpo monoclonal, radioinmunoconjugado , CAF o cualquier quimioterapéutico u otro antineoplásicoen las 4 semanas anteriores a la primera dosis del tratamiento del estudio
    - Tratamiento con radioterapia en las 2 semanas anteriores a la administración de la primera dosis del tratamiento del estudio
    - ACM autólogo en los 100 días anteriores a la administración del primer tratamiento del estudio o cualquier transplante de células madres TCM alogénico o transplante de órgano sólido
    - Tratamiento previo con terapia CAR-T en los 30 días anteriores a la administración del primer tratamiento del estudio
    - Linfoma del SNC actual o antecedentes de dicha afección, Enfermedad del SNC actual o antecedentes de ella
    - Cardiovasculopatía significativa o enfermedad pulmonar
    - Cirugía mayor reciente en las 4 semanas anteriores a la administración de la primera dosis del tratamiento del estudio
    -Hepatitis B o C o virus de inmunodeficiencia humana (VIH)
    - Administración de una vacuna elaborada con microbios vivos atenuados en las 4 semanas previas a la administración de la primera dosis del tratamiento del estudio o previsión de que se requiera dicha vacuna durante el estudio
    -Antecedentes de enfermedad autoinmunitaria (enfermedades autoinmunitaria estable pueden ser elegibles).
    -Administración de inmunodepresores sistémico en las 2 semanas anteriores a la administración de la primera dosis del tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    1. Occurrence and severity of adverse events, including DLTs (Phase Ib)
    2. Change from baseline in targeted vital signs (Phase Ib),
    3. Change from baseline in targeted clinical laboratory test results (Phase Ib)
    4. CR rate at the time of PRA as determined by the investigator (Phase Ib)
    5. Best ORR as determined by the investigator (Phase Ib)
    6. DOR as determined by the investigator (Phase Ib)
    7. Best ORR, as determined by the IRC (Phase II)
    1. Aparición y gravedad de acontecimientos adversos, entre estos, TLD (Fase Ib)
    2. Variación con respecto al momento basal en las constantes vitales seleccionadas (Fase Ib)
    3. Variación con respecto al momento basal en los resultados de análisis clínicos específicos (Fase Ib)
    4. Tasa de RC en el momento de la ERP basada en la TEP-TAC, determinada por el investigador (Fase Ib)
    5. Mejor TRO determinada por el investigador conforme (Fase Ib)
    6. DdR determinada por el investigador conforme (Fase Ib)
    7. Mejor TRO determinada por el CRI
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From Cycle 1 Day 1 until 90 days after the last dose of study drug administration
    2-3. From baseline until 90 days after the last dose of study drug administration
    4. At the completion of 8 cycles of Mosun
    5-7. From baseline up to approximately 80 months (until disease progression, start of new anti-cancer therapy, or withdrawal)
    1. Desde el día 1 del ciclo 1 hasta 90 días después de la última dosis de la administración del fármaco del estudio
    2-3. Desde el momento basal hasta 90 días después de la última dosis de administración del fármaco del estudio.
    4. Al completar 8 ciclos de Mosun
    5-7. Desde el momento basal hasta aproximadamente 80 meses (hasta la progresión de la enfermedad, el inicio de una nueva terapia contra el cáncer o el retiro)
    E.5.2Secondary end point(s)
    1. Best ORR as determined by the investigator (Phase II)
    2. Best CR rate as determined by the investigator and IRC (Phase II)
    3. CR rate at the time of PRA as determined by the investigator and IRC (Phase II)
    4. ORR at the time of PRA as determined by the investigator and IRC (Phase II)
    5. DOR as determined by the investigator and IRC (Phase II)
    6. PFS as determined by the investigator and IRC (Phase II)
    7. EFS as determined by the investigator and IRC (Phase II)
    8. OS (Phase II)
    9. Occurrence and severity of adverse events (Phase II)
    10. Change from baseline in targeted vital signs (Phase II)
    11. Change from baseline in targeted clinical laboratory test results (Phase II)
    12. Maximum serum concentration (Cmax) for Mosun (Phase Ib and II)
    13. Minimum serum concentration (Cmin) for Mosun (Phase Ib and II)
    14. Total exposure area under the concentrationtime curve (AUC) for Mosun (Phase Ib and II)
    15. Clearance for Mosun (Phase Ib and II)
    16. Volume of distribution for Mosun (Phase Ib and II)
    17. Relationship between ADA status and efficacy, safety, pharmacokinetics, and biomarkers (Phase Ib and II)
    1. Mejor TRO determinada por el investigador (Fase II)
    2. Mejor tasa de RC determinada por el investigador y el CRI (Fase II)
    3. Tasa de RC en el momento de la ERP determinada por el investigador y el CRI (Fase II)
    4. TRO en el momento de la ERP determinada por el investigador y el CRI (Fase II)
    5. DdR determinado por el investigador y el CRI (Fase II)
    6. SSP determinada por el investigador y el CRI (Fase II)
    7. SSC determinada por el investigador y el CRI (Fase II)
    8. SG (Fase II)
    9. Aparición y gravedad de acontecimientos adversos (Fase II)
    10. Variación con respecto al momento basal en las constantes vitales seleccionadas (Fase II)
    11. Variación con respecto al momento basal en los resultados de análisis clínicos específicos (Fase II)
    12. Concentración sérica máxima (Cmax) de Mosun (Fase Ib y Fase II)
    13. Concentración sérica mínima (Cmin) de Mosun (Fase Ib y Fase II)
    14. Exposición total área bajo la curva de concentración-tiempo (ABC) de Mosun (Fase Ib y Fase II)
    15. Aclaramiento de Mosun (Fase Ib y Fase II)
    16. Volumen de distribución de Mosun (Fase Ib y Fase II)
    17. Relación entre el estado de los AAF y los criterios de valoración de la eficacia, la seguridad, la farmacocinética y los biomarcadores (Fase Ib y Fase II)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. From baseline up to approximately 80 months (until disease progression, start of new anti-cancer therapy, or withdrawal)
    3-4. At the completion of 8 cycles of Mosun
    5-7. From baseline up to approximately 80 months (until disease progression, start of new anti-cancer therapy, or withdrawal)
    8. From baseline until death from any cause (up to approximately 80 months)
    9. From Cycle 1 Day 1 until 90 days after the last dose of study drug administration
    10-11. From baseline until 90 days after the last dose of study drug administration
    12-17. At predose and postdose during treatment, at treatment completion/discontinuation and during follow-up, up to 15 months
    1-2. Desde el momento basal hasta aprox 80 meses (hasta la progresión de la enfermedad, el inicio de una nueva terapia contra el cáncer o el retiro)
    3-4 .Al completar 8 ciclos de Mosun
    5-7. Desde el momento basal hasta aprox 80 meses (hasta la progresión de la enfermedad, el inicio de una nueva terapia contra el cáncer o el retiro)
    8. Desde el momento basal hasta la muerte por cualquier causa (hasta aprox 80 meses)
    9. Desde el día 1 del ciclo 1 hasta 90 días después de la última dosis de la administración del fármaco del estudio
    10-11. Desde el momento basal hasta 90 días después de la última dosis de admin del fármaco del estudio
    12-17. Antes y después de la dosis durante el tratamiento, al finalizar / suspender el tto y durante el seguimiento, hasta 15 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, immunogenicity, biomarkers
    Tolerabilidad, Inmunogenicidad y biomarcadores
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase Ib dose-finding and randomized phase II for R/R DLBCL
    Fase Ib búsqueda de dosis y fase II aleatorizada para (LDLBG) R/R
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Fase II aleatorizada para (LDLBG) R/R: Mosun SC + Polivy (brazo L) vs MabThera +Polivy (brazo M)
    Randomized Ph II for R/R DLBCL: Mosunetuzumab SC + Polivy (Arm L) vs MabThera +Polivy (Arm M)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    Belgium
    Spain
    United Kingdom
    E.8.7Trial 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, or the date at which the last data point required for statistical analysis or safety follow-up is received from the last patient, whichever occurs later.
    El final de este estudio se define como la fecha en la que se produzca la última visita del último paciente o la fecha en la que se reciban los últimos datos del último paciente necesarios para el análisis estadístico o el seguimiento de seguridad, lo que ocurra después
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 205
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 342
    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)
    The Sponsor will offer continued access to Roche IMPs (mosunetuzumab, polatuzumab vedotin, rituximab, and tocilizumab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in section 4.3.5 of study protocol.
    El Promotor ofrecerá acceso continuo a los IMP de Roche (mosunetuzumab, polatuzumab vedotin, rituximab y tocilizumab) de forma gratuita a los pacientes elegibles de acuerdo con la Política global de Roche sobre el acceso continuo a medicamentos en investigación, como se describe en la sección 4.3.5 del estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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