An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed R/R DLBCL after one line of systemic therapy

Will be treated with Glofit-based regimen (known as being recommended and having the intention to be treated with Glofitamab at the time of signing ICF) or have initiated Glofit-based regimen treatment within three months (90 days) prior to enrollment

Disqualifiers

Participants who currently participate in or plan to participate in any interventional clinical trial

Trial population

Adult Chinese participants with R/R DLBCL who will be treated with a glofitamab-based regimen either after enrollment into the study or within 90 days prior to enrollment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Glofitamab

    Drug

    Participants will receive glofitamab as part of a cancer-treatment regimen in a real-world setting. No intervention will be administered by study investigators.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Glofitamab treatment1 intervention

Trial outcomes

Primary outcomes

1

real-world Progression-Free Survival (rwPFS)

Time frame
Up to approximately 4 years

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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