B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R/R). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. However, large-scale real-world efficacy and safety data in Chinese clinical practice are still lacking, particularly regarding combination with different regimens and use in the relapsed population. This is a prospective, multicenter, observational registry study evaluating the efficacy and safety of CD20xCD3 bispecific antibody-containing regimens in patients with relapsed or refractory B-cell non-Hodgkin lymphoma in a real-world setting. Efficacy is assessed using the Lugano 2014 response criteria. The primary endpoint is best objective response rate (ORR).
Study design: Prospective, multicenter, observational (non-interventional) registry study. Population: Patients aged \>=18 years with histologically confirmed B-cell non-Hodgkin lymphoma who are relapsed or refractory after at least one prior line of therapy and who receive a CD20xCD3 bispecific antibody-containing regimen after study initiation. Efficacy evaluation: Lugano 2014 response criteria. Primary endpoint: Best objective response rate (ORR). Secondary endpoints: Complete response rate (CRR), disease control rate (DCR), duration of response (DOR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety. Exploratory endpoints: Subgroup analyses by combination pattern (e.g., combined with chemotherapy or targeted agents) and special populations; correlation of biomarkers (e.g., peripheral blood lymphocyte subsets, T-lymphocyte mitochondrial immune analysis, cytokines) with efficacy and safety; and patient compliance and quality-of-life analyses based on electronic patient-reported outcomes (ePRO). Planned enrollment: 200 participants. As a non-interventional study, no formal statistical hypothesis is tested; the sample size is based on the confidence-interval width method (expected ORR P=0.5, half-width d=0.07), yielding approximately 196 participants, rounded to 200.
Study Type
OBSERVATIONAL
Enrollment
200
Glofitamab, a CD20xCD3 bispecific monoclonal antibody, administered per real-world clinical practice and product labeling. As an observational study, treatment is determined by the treating physician and not by the study protocol; the intervention of interest is recorded to describe the treated population.
Henan Cancer Hospital
Zhengzhou, Henan, China
Best Overall Response Rate (ORR)
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to the Lugano 2014 response criteria for malignant lymphoma.
Time frame: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
Disease Control Rate (DCR)
DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per Lugano 2014 criteria.
Time frame: From treatment initiation until disease progression, assessed up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, whichever occurs first, among responders.
Time frame: From first response until disease progression or death, assessed up to approximately 2 years
Time to Next Treatment (TTNT)
TTNT is defined as the time from treatment initiation to the start of the next line of anti-lymphoma therapy or death from any cause, whichever occurs first.
Time frame: From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from treatment initiation to the first documented disease progression per Lugano 2014 criteria or death from any cause, whichever occurs first.
Time frame: From treatment initiation until disease progression or death, assessed up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from treatment initiation to death from any cause.
Time frame: From treatment initiation until death from any cause, assessed up to approximately 2 years
Incidence of Adverse Events (Safety)
Safety is assessed by the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest such as cytokine release syndrome (CRS), graded per NCI CTCAE and, for CRS, per ASTCT consensus criteria.
Time frame: From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
Complete Response Rate (CRR)
CRR is defined as the proportion of participants achieving a best overall response of complete response (CR) per Lugano 2014 criteria.
Time frame: From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years
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