DLBCL - Diffuse Large B Cell Lymphoma
Conditions
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.
Interventions
DRUGGlofitamab
Glofitamab given in standard dosage
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically-confirmed DLBCL 2. Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy 3. Participants must have measurable disease
Exclusion criteria
1. Pregnancy or breastfeeding 2. Patient with known active infection, or reactivation of a latent infection 3. Patient with active autoimmune disease or immune deficiency 4. severe organ failure：LVEF\<40%；DLCO\<40%；eGFR\<30ml/min；Bilirubin≥3ULN 5. Patients who are dependent on the sponsor, the investigator or the trial site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1 year | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 2 year | overall survival |
| CR rate | 6 weeks, 18 weeks, 36 weeks | complete response |
| ORR | 6 weeks, 18 weeks, 36 weeks | overall response rate |
| DOR | 2 year | duration of response |
| AE | 2 year | Rate and type of adverse events (AEs) and serious adverse events (SAEs) |
Countries
China
Contacts
CONTACTJing Ruan
Outcome results
None listed