An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
- Registration Number
- NCT07200375
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Histologically confirmed R/R DLBCL after one line of systemic therapy
- Will be treated with Glofit-based regimen (known as being recommended and having the intention to be treated with Glofitamab at the time of signing ICF) or have initiated Glofit-based regimen treatment within three months (90 days) prior to enrollment
- Participants who currently participate in or plan to participate in any interventional clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Glofitamab treatment Glofitamab Participants will be enrolled into the study either prior to initiation of glofitamab therapy or within 90 days of starting glofitamab therapy.
- Primary Outcome Measures
Name Time Method real-world Progression-Free Survival (rwPFS) Up to approximately 4 years
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to approximately 4 years ORR is defined as the proportion of patients whose BOR is a CR or a partial response (PR) during the study assessed by the investigator according to 2014 Lugano Response Criteria for Malignant Lymphoma
Disease Control Rate (DCR) Up to approximately 4 years DCR is defined as the proportion of patients achieving CR, PR or stable disease (SD) during the study assessed by the investigator according to 2014 Lugano Response Criteria for Malignant Lymphoma
Duration of Response (DoR) Up to approximately 4 years DoR is defined as the time interval from the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first assessed by the investigator according to 2014 Lugano Response Criteria for Malignant Lymphoma
Duration of Complete Response (DoCR) Up to approximately 4 years DoCR is defined as the time interval from the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first
Overall Survival (OS) Up to approximately 4 years OS is defined as the time from treatment start of the Glofit-based regimen until the date of death from any cause
Time to Next Treatment (TTNT) Up to approximately 4 years TTNT is defined as the time from treatment start of the Glofit-based regimen to the initiation of next-line treatment
Complete Response Rate (CRR) Up to approximately 4 years CRR is defined as the proportion of participants whose best overall response (BOR) is a complete response (CR) on positron emission tomography/computed tomography (PET/CT) or CT during the study assessed by the investigator according to 2014 Lugano Response Criteria for Malignant Lymphoma
Event-Free Survival (EFS) Up to approximately 4 years EFS is defined as the time from treatment start of the Glofit-based regimen to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first, as determined by the investigator assessment according to 2014 Lugano Response Criteria for Malignant Lymphoma