Diffuse Large B Cell Lymphoma (DLBCL)
Conditions
Brief summary
The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.
Interventions
DRUGGlofitamab
Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling.
DRUGObinutuzumab
Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be diagnosed as R/R DLBCL * Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.
Exclusion criteria
* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to end of study (EOS) (approximately 48 months) |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOS (approximately 48 months) |
| Duration of Response (DoR) | From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months) |
| Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOS (approximately 48 months) |
| Time to Next Treatment (TTNT) | From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months) |
| Overall Survival (OS) | From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 months) |
| Duration of Complete Response (DoCR) | From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months) |
Countries
China
Contacts
Primary ContactWeili Zhao
Outcome results
None listed