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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06084936




Registration number
NCT06084936
Ethics application status
Date submitted
14/09/2023
Date registered
16/10/2023

Titles & IDs
Public title
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Scientific title
A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Secondary ID [1] 0 0
GO43878
Universal Trial Number (UTN)
Trial acronym
GLOBRYTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Glofitamab
Treatment: Drugs - Rituximab
Treatment: Drugs - Bendamustine
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Tocilizumab

Experimental: Glofitamab monotherapy - Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).

Active comparator: BR or R-Len - Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.


Treatment: Drugs: Obinutuzumab
Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1

Treatment: Drugs: Glofitamab
Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).

Treatment: Drugs: Rituximab
Participants will receive IV rituximab every 28 days for up to 6 cycles (when in combination with bendamustine), or until disease progression (when in combination with lenalidomide).

Treatment: Drugs: Bendamustine
Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).

Treatment: Drugs: Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.

Treatment: Drugs: Tocilizumab
Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months)
Secondary outcome [1] 0 0
Complete response (CR) rate
Timepoint [1] 0 0
Up to approximately 24 months
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Up to approximately 24 months
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
From randomization to death from any cause (up to approximately 24 months)
Secondary outcome [4] 0 0
Time to deterioration in physical functioning/fatigue
Timepoint [4] 0 0
From randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months)
Secondary outcome [5] 0 0
Investigator-assessed PFS
Timepoint [5] 0 0
From randomization to disease progression or death from any cause (up to approximately 24 months)
Secondary outcome [6] 0 0
Investigator-assessed CR rate
Timepoint [6] 0 0
Up to approximately 24 months
Secondary outcome [7] 0 0
Investigator-assessed ORR
Timepoint [7] 0 0
Up to approximately 24 months
Secondary outcome [8] 0 0
Duration of Complete Response (DOCR)
Timepoint [8] 0 0
From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)
Secondary outcome [9] 0 0
Duration of Response (DOR)
Timepoint [9] 0 0
From the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first (up to approximately 24 months)
Secondary outcome [10] 0 0
Proportion of participants reporting each response option for item GP5 from the Functional Assessment of Cancer Therapy - General (FACT-G) subscale
Timepoint [10] 0 0
Up to approximately 24 months
Secondary outcome [11] 0 0
Time to deterioration in lymphoma symptoms
Timepoint [11] 0 0
From randomization to the first documentation of a 3-point or more decrease in score as assessed by the FACT-Lym lymphoma subscale (LymS) questionnaire (up to approximately 24 months)
Secondary outcome [12] 0 0
Proportion of participants experiencing a clinically meaningful improvement (3-point or more increase) in lymphoma symptoms as assessed through use of the FACT-Lym LymS
Timepoint [12] 0 0
Up to approximately 24 months
Secondary outcome [13] 0 0
Change from baseline in physical functioning and fatigue at each cycle as assessed by the European Organization for Research and Treatment (EORTC) core Quality of Life Questionnaire (QLQ-C30)
Timepoint [13] 0 0
Up to approximately 24 months
Secondary outcome [14] 0 0
Change from baseline in lymphoma symptoms at each cycle as assessed by the FACT-Lym LymS
Timepoint [14] 0 0
Up to approximately 24 months
Secondary outcome [15] 0 0
Serum concentration of glofitamab
Timepoint [15] 0 0
Up to approximately 24 months
Secondary outcome [16] 0 0
Incidence of anti-drug antibodies (ADAs)
Timepoint [16] 0 0
Up to approximately 24 months

Eligibility
Key inclusion criteria
* Life expectancy at least 12 weeks
* Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14)
* Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease
* At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option
* Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment
* At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Negative HIV test at screening
* Adequate hematological function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer
* Leukemic, non-nodal MCL
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
* Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide
* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
* Prior treatment with CAR-T cell therapy
* Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment
* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
* Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Significant or extensive cardiovascular disease
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
* Suspected or latent tuberculosis
* Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Known or suspected chronic active Epstein-Barr viral infection (EBV)
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Known history of progressive multifocal leukoencephalopathy (PML)
* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better
* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
* Prior solid organ transplantation or allogenic stem cell transplant
* Eligibility for stem cell transplantation (SCT)
* Active autoimmune disease requiring treatment
* Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment
* Corticosteroid therapy within 2 weeks prior to first dose of study treatment
* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
* Clinically significant history of cirrhotic liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
182
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle; Medical Oncology - Waratah
Recruitment hospital [2] 0 0
Royal Adelaide Hospital; Haematology Clinical Trials - Adelaide
Recruitment hospital [3] 0 0
Epworth Hospital - Richmond
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
South Dakota
Country [5] 0 0
Brazil
State/province [5] 0 0
PR
Country [6] 0 0
Brazil
State/province [6] 0 0
RJ
Country [7] 0 0
Brazil
State/province [7] 0 0
RS
Country [8] 0 0
Brazil
State/province [8] 0 0
SP
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Changchun City
Country [12] 0 0
China
State/province [12] 0 0
Chengdu City
Country [13] 0 0
China
State/province [13] 0 0
Chongqing
Country [14] 0 0
China
State/province [14] 0 0
Fuzhou City
Country [15] 0 0
China
State/province [15] 0 0
Guangzhou
Country [16] 0 0
China
State/province [16] 0 0
Nanning City
Country [17] 0 0
China
State/province [17] 0 0
Shanghai City
Country [18] 0 0
China
State/province [18] 0 0
Shenyang City
Country [19] 0 0
China
State/province [19] 0 0
Wenzhou City
Country [20] 0 0
China
State/province [20] 0 0
Zhengzhou City
Country [21] 0 0
China
State/province [21] 0 0
Zhengzhou
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Montpellier
Country [24] 0 0
France
State/province [24] 0 0
Nantes
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
St Cloud
Country [27] 0 0
Italy
State/province [27] 0 0
Emilia-Romagna
Country [28] 0 0
Italy
State/province [28] 0 0
Lombardia
Country [29] 0 0
Italy
State/province [29] 0 0
Piemonte
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Daejeon
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Spain
State/province [32] 0 0
Cadiz
Country [33] 0 0
Spain
State/province [33] 0 0
LA Coruña
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Murcia
Country [36] 0 0
Sweden
State/province [36] 0 0
Lund
Country [37] 0 0
Sweden
State/province [37] 0 0
Uppsala
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
Taiwan
State/province [39] 0 0
Taoyuan
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Glasgow
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Oxford
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO43878 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06084936