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Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

ConditionRelapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYanyan Liu

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice at participating hospitals in China.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Glofitamab

    Biological/Vaccine

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: R/R B-NHL treated with bispecific antibody1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yanyan Liu

Lead sponsor

Henan Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: