Diffuse Large B-Cell Lymphoma
Conditions
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).
Interventions
DRUGGlofitamab
Participants will receive glofitamab as part of a cancer-treatment regimen in a real-world setting. No intervention will be administered by study investigators.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Participants who currently participate in or plan to participate in any interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| real-world Progression-Free Survival (rwPFS) | Up to approximately 4 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
China, Hong Kong
Contacts
CONTACTReference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed