An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
GlofitReal
Evaluating Effectiveness and Safety of Glofitamab Based Second-Line Therapy in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Cohort Study
1 other identifier
observational
300
1 country
17
Brief Summary
This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2025
CompletedStudy Start
First participant enrolled
September 29, 2025
CompletedFirst Posted
Study publicly available on registry
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 29, 2029
May 4, 2026
May 1, 2026
4 years
September 23, 2025
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
real-world Progression-Free Survival (rwPFS)
Up to approximately 4 years
Secondary Outcomes (8)
Complete Response Rate (CRR)
Up to approximately 4 years
Overall Response Rate (ORR)
Up to approximately 4 years
Disease Control Rate (DCR)
Up to approximately 4 years
Duration of Response (DoR)
Up to approximately 4 years
Duration of Complete Response (DoCR)
Up to approximately 4 years
- +3 more secondary outcomes
Study Arms (1)
Glofitamab treatment
Participants will be enrolled into the study either prior to initiation of glofitamab therapy or within 90 days of starting glofitamab therapy.
Interventions
Participants will receive glofitamab as part of a cancer-treatment regimen in a real-world setting. No intervention will be administered by study investigators.
Eligibility Criteria
Adult Chinese participants with R/R DLBCL who will be treated with a glofitamab-based regimen either after enrollment into the study or within 90 days prior to enrollment.
You may qualify if:
- Histologically confirmed R/R DLBCL after one line of systemic therapy
- Will be treated with Glofit-based regimen (known as being recommended and having the intention to be treated with Glofitamab at the time of signing ICF) or have initiated Glofit-based regimen treatment within three months (90 days) prior to enrollment
You may not qualify if:
- Participants who currently participate in or plan to participate in any interventional clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Cancer Hospital Chinese Academy of Medical Sciences.
Langfang, Hebei, 065001, China
Chinese Academy of Medical Sciences Hematology Hospital;Lymphoma Diagnosis and Treatment Center
Tianjin, Tianjin Municipality, 301636, China
Peking University People's Hospital
Beijing, 100044, China
Peking University Third Hospital
Beijing, 100191, China
The First Bethune Hospital of Jilin University
Changchun, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shandong Cancer Hospital
Jinan, 250117, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Tianjin Cancer Hospital
Tianjin, 300060, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325035, China
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430022, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, 430030, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061, China
Yantai Yu Huangding Hospital
Yantai, 264099, China
Henan Cancer Hospital
Zhengzhou, 450008, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: ML45172 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2025
First Posted
October 1, 2025
Study Start
September 29, 2025
Primary Completion (Estimated)
September 29, 2029
Study Completion (Estimated)
September 29, 2029
Last Updated
May 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share