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).
Study Type
OBSERVATIONAL
Enrollment
300
Participants will receive glofitamab as part of a cancer-treatment regimen in a real-world setting. No intervention will be administered by study investigators.
Cancer Hospital Chinese Academy of Medical Sciences.
real-world Progression-Free Survival (rwPFS)
Time frame: Up to approximately 4 years
Complete Response Rate (CRR)
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
Time frame: Up to approximately 4 years
Overall Response Rate (ORR)
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
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
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
Time frame: Up to approximately 4 years
Duration of Response (DoR)
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
Time frame: Up to approximately 4 years
Duration of Complete Response (DoCR)
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
Time frame: Up to approximately 4 years
Reference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below.
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CONTACT
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Langfang, Hebei, China
Chinese Academy of Medical Sciences Hematology Hospital;Lymphoma Diagnosis and Treatment Center
Tianjin, Tianjin Municipality, China
RECRUITINGPeking University People's Hospital
Beijing, China
RECRUITINGPeking University Third Hospital
Beijing, China
RECRUITINGThe First Bethune Hospital of Jilin University
Changchun, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, China
RECRUITINGShandong Cancer Hospital
Jinan, China
RECRUITINGThe Second Affiliated Hospital of Nanchang University
Nanchang, China
RECRUITING...and 12 more locations
Overall Survival (OS)
OS is defined as the time from treatment start of the Glofit-based regimen until the date of death from any cause
Time frame: Up to approximately 4 years
Event-Free Survival (EFS)
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 frame: Up to approximately 4 years
Time to Next Treatment (TTNT)
TTNT is defined as the time from treatment start of the Glofit-based regimen to the initiation of next-line treatment
Time frame: Up to approximately 4 years