Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glofitamab.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Overview
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
- Biological Glofitamab
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.
Primary outcome measures
- Best Overall Response Rate (ORR) [Time frame: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years]
Secondary outcome measures (7)
- Disease Control Rate (DCR) [Time frame: From treatment initiation until disease progression, assessed up to approximately 2 years]
- Duration of Response (DOR) [Time frame: From first response until disease progression or death, assessed up to approximately 2 years]
- Time to Next Treatment (TTNT) [Time frame: From treatment initiation until start of next therapy or death, assessed up to approximately 2 years]
- Progression-Free Survival (PFS) [Time frame: From treatment initiation until disease progression or death, assessed up to approximately 2 years]
- Overall Survival (OS) [Time frame: From treatment initiation until death from any cause, assessed up to approximately 2 years]
- Incidence of Adverse Events (Safety) [Time frame: From treatment initiation until 90 days after last dose, assessed up to approximately 2 years]
- Complete Response Rate (CRR) [Time frame: From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Henan Cancer Hospital — Zhengzhou
Identifiers
NCT: NCT07695896 · HNSZLYYNHL12 · 2026-254