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

Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Alta Bates Summit Medical Center
WITHDRAWN
Berkeley
City of Hope Cancer Center
RECRUITING
Duarte
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica
RECRUITING
Santa Monica
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Florida
University of Miami
RECRUITING
Coral Gables
Indiana
Indiana University
WITHDRAWN
Indianapolis
Michigan
University of Michigan Health System
RECRUITING
Ann Arbor
Missouri
St. Luke's Hospital
RECRUITING
Chesterfield
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
University of Rochester
RECRUITING
Rochester
South Carolina
Medical University of S. Carolina
RECRUITING
Charleston
South Dakota
Avera Cancer Institute
WITHDRAWN
Sioux Falls
Texas
Renovatio Clinical - El Paso
RECRUITING
El Paso
Renovatio Clinical
RECRUITING
The Woodlands
Virginia
University of Virginia
RECRUITING
Charlottesville
West Virginia
West Virginia University
RECRUITING
Morgantown
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Epworth Hospital
RECRUITING
Richmond
Calvary Mater Newcastle
RECRUITING
Waratah
Brazil
ICTR Curitiba
RECRUITING
Curitiba
Hospital Mae de Deus
RECRUITING
Porto Alegre
Americas Medical City
RECRUITING
Rio De Janeiro
Hospital Sao Rafael - HSR
RECRUITING
Salvador
Beneficencia Portuguesa de Sao Paulo
RECRUITING
São Paulo
Hospital A. C. Camargo
RECRUITING
São Paulo
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Hospital Paulistano
RECRUITING
São Paulo
Instituto D'Or Pesquisa e Ensino
RECRUITING
São Paulo
Canada
Victoria Hospital - London Health Sciences Centre
RECRUITING
London
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
Princess Margaret Cancer Center
RECRUITING
Toronto
China
Beijing Tong Ren Hospital, Capital Medical University
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
West China Hospital of Sichuan University
ACTIVE_NOT_RECRUITING
Chengdu
Chongqing Cancer Hospital
RECRUITING
Chongqing
Fujian Provincial Cancer Hospital
RECRUITING
Fuzhou
Sun yat-sen University Cancer Center
ACTIVE_NOT_RECRUITING
Guangzhou
Guangxi Cancer Hospital of Guangxi Medical University
RECRUITING
Nanning
Fudan University Shanghai Cancer Center
ACTIVE_NOT_RECRUITING
Shanghai
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
The First Affiliated Hospital of Wenzhou Medical University
COMPLETED
Wenzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
France
Hopital Claude Huriez
RECRUITING
Lille
Hopital Saint Eloi
RECRUITING
Montpellier
CHU NANTES - Hôtel Dieu
RECRUITING
Nantes
Hopital Necker
RECRUITING
Paris
INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.
RECRUITING
Paris
Italy
SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo
RECRUITING
Alessandria
Humanitas Gavazzeni
RECRUITING
Bergamo
Policlinico S.Orsola-Malpighi
ACTIVE_NOT_RECRUITING
Bologna
Irccs Istituto Europeo Di Oncologia (IEO)
RECRUITING
Milan
A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette
RECRUITING
Turin
Puerto Rico
Auxilio Mutuo Cancer Center
RECRUITING
San Juan
Republic of Korea
Chungnam National University Hospital
WITHDRAWN
Daejeon
Asan Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
ACTIVE_NOT_RECRUITING
Seoul
Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
RECRUITING
A Coruña
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Puerta del Mar
RECRUITING
Cadiz
Hospital General Universitario J.M Morales Meseguer
RECRUITING
Murcia
Sweden
Skånes University Hospital, Skånes Department of Onclology
RECRUITING
Lund
Akademiska sjukhuset, Onkologkliniken
RECRUITING
Uppsala
Taiwan
National Taiwan Universtiy Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation - Linkou
RECRUITING
Taoyuan District
United Kingdom
NHS Greater Glasgow and Clyde
RECRUITING
Glasgow
Lincolnshire County Hospital
RECRUITING
Lincoln
University College London Hospital
RECRUITING
London
Christie Hospital Nhs Trust
RECRUITING
Manchester
Oxford Churchill Hospital
RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
Contact Information
Primary
Reference Study ID Number: GO43878 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date: 2023-10-22
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 182
Treatments
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.
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov