Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Conditions
Keywords
B-cell non-Hodgkin lymphoma, Bispecific antibody, Glofitamab, CD20xCD3, Real-world study, Relapsed refractory
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALGlofitamab
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.
Sponsors
Yanyan Liu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years at the start of treatment * Histologically confirmed B-cell non-Hodgkin lymphoma * Relapsed or refractory disease after at least one prior line of systemic therapy * Planned to receive a CD20xCD3 bispecific antibody-containing regimen after study initiation * Signed informed consent for the investigational treatment
Exclusion criteria
* Currently participating in, or planning to participate in, any interventional clinical trial * Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response Rate (ORR) | From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | From treatment initiation until disease progression, assessed up to approximately 2 years | DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per Lugano 2014 criteria. |
| Duration of Response (DOR) | From first response until disease progression or death, assessed up to approximately 2 years | 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 to Next Treatment (TTNT) | From treatment initiation until start of next therapy or death, assessed up to approximately 2 years | 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. |
| Progression-Free Survival (PFS) | From treatment initiation until disease progression or death, assessed up to approximately 2 years | 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. |
| Overall Survival (OS) | From treatment initiation until death from any cause, assessed up to approximately 2 years | OS is defined as the time from treatment initiation to death from any cause. |
| Incidence of Adverse Events (Safety) | From treatment initiation until 90 days after last dose, assessed up to approximately 2 years | 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. |
| Complete Response Rate (CRR) | From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years | CRR is defined as the proportion of participants achieving a best overall response of complete response (CR) per Lugano 2014 criteria. |
Countries
China
Contacts
CONTACTYanyan Liu
PRINCIPAL_INVESTIGATORYanyan Liu
Henan Cancer Hospital
Outcome results
None listed