B-cell Non-Hodgkin Lymphoma
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma.
Interventions
DRUGGlofitamab
Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling
Sponsors
The First Affiliated Hospital of Soochow University
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 B-NHL * Relapse or refractory to previous treatment * Participants who will be treated with glofitamab
Exclusion criteria
* Participant who currently participates in or with plan to participate in any interventional clinical trial * Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOT (approximately 9 months) |
Secondary
| Measure | Time frame |
|---|---|
| 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 24 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 24 months) |
| PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to end of study (approximately 24 months) |
| Best Overall Response Rate (bORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOT (approximately 9 months) |
| Overall Survival (OS) | From the start of glofitamab treatment until the date of death from any cause (up to approximately 24 months) |
| Time to Next Treatment (TTNT) | From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 24 months) |
| Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | From the start of glofitamab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 24 months) |
Countries
China
Contacts
Primary ContactHaiwen Huang
Outcome results
None listed