Glofitamab in Chinese Patients With R/R DLBCL
- Registration Number
- NCT06481826
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description treatment group Glofitamab Glofitamab
- Primary Outcome Measures
Name Time Method PFS 1 year Progression-free survival
- Secondary Outcome Measures
Name Time Method ORR 6 weeks, 18 weeks, 36 weeks overall response rate
OS 2 year overall survival
DOR 2 year duration of response
AE 2 year Rate and type of adverse events (AEs) and serious adverse events (SAEs)
CR rate 6 weeks, 18 weeks, 36 weeks complete response
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China