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NCT Number: NCT07200375

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

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).

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital Chinese Academy of Medical Sciences., Langfang, Hebei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. real-world Progression-Free Survival (rwPFS)

    Time frame: Up to approximately 4 years

Secondary outcomes

  1. Complete Response Rate (CRR)

    Time frame: Up to approximately 4 years

    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

  2. Overall Response Rate (ORR)

    Time frame: Up to approximately 4 years

    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

  3. Disease Control Rate (DCR)

    Time frame: Up to approximately 4 years

    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

  4. Duration of Response (DoR)

    Time frame: Up to approximately 4 years

    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

  5. Duration of Complete Response (DoCR)

    Time frame: Up to approximately 4 years

    DoCR is defined as the time interval from the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first

  6. Overall Survival (OS)

    Time frame: Up to approximately 4 years

    OS is defined as the time from treatment start of the Glofit-based regimen until the date of death from any cause

  7. Event-Free Survival (EFS)

    Time frame: Up to approximately 4 years

    EFS is defined as the time from treatment start of the Glofit-based regimen to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first, as determined by the investigator assessment according to 2014 Lugano Response Criteria for Malignant Lymphoma

  8. Time to Next Treatment (TTNT)

    Time frame: Up to approximately 4 years

    TTNT is defined as the time from treatment start of the Glofit-based regimen to the initiation of next-line treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Evaluating Effectiveness and Safety of Glofitamab Based Second-Line Therapy in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Cohort Study

Acronym: GlofitReal

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 1, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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