Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
Recruiting
NCT Number: NCT06481826
Glofitamab in Chinese Patients With R/R DLBCL
This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Histologically-confirmed DLBCL
- Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy
- Participants must have measurable disease
Exclusion criteria
- Pregnancy or breastfeeding
- Patient with known active infection, or reactivation of a latent infection
- Patient with active autoimmune disease or immune deficiency
- severe organ failure：LVEF<40%；DLCO<40%；eGFR<30ml/min；Bilirubin≥3ULN
- Patients who are dependent on the sponsor, the investigator or the trial site
Treatment and study plan
Glofitamab
DrugGlofitamab given in standard dosage
Primary outcomes
-
PFS
Time frame: 1 year
Progression-free survival
Secondary outcomes
-
OS
Time frame: 2 year
overall survival
-
CR rate
Time frame: 6 weeks, 18 weeks, 36 weeks
complete response
-
ORR
Time frame: 6 weeks, 18 weeks, 36 weeks
overall response rate
-
DOR
Time frame: 2 year
duration of response
-
AE
Time frame: 2 year
Rate and type of adverse events (AEs) and serious adverse events (SAEs)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Peking Union Medical College Hospital
Other
Registry information
Official study title
A Study to Evaluate Glofitamab as Single Agent in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Jul 1, 2024
- Registry last updated
- Mar 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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