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RecruitingNCT07200375GlofitRealUpdated Sep 8, 2026

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

An observational study in Diffuse Large B-Cell Lymphoma, sponsored by Hoffmann-La Roche. Recruiting at 22 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Diffuse Large B-Cell Lymphoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

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

Exclusion Criteria:

  • Participants who currently participate in or plan to participate in any interventional clinical trial
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Glofitamab treatment

    Participants will be enrolled into the study either prior to initiation of glofitamab therapy or within 90 days of starting glofitamab therapy.

    Drug: Glofitamab

Interventions

  • DrugGlofitamab

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

05

What researchers measure

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

  5. Duration of Complete Response (DoCR)

    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

    Time frame: Up to approximately 4 years

  6. Overall Survival (OS)

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

    Time frame: Up to approximately 4 years

  7. Event-Free Survival (EFS)

    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

    Time frame: Up to approximately 4 years

  8. Time to Next Treatment (TTNT)

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

    Time frame: Up to approximately 4 years

06

Study locations

22 of 22 sites recruiting
  • Cancer Hospital Chinese Academy of Medical Sciences.
    Langfang, Hebei 065001, China
    Recruiting
  • Chinese Academy of Medical Sciences Hematology Hospital;Lymphoma Diagnosis and Treatment Center
    Tianjin, Tianjin Municipality 301636, China
    Recruiting
  • Peking University People's Hospital
    Beijing, 100044, China
    Recruiting
  • Peking University Third Hospital
    Beijing, 100191, China
    Recruiting
  • The First Bethune Hospital of Jilin University
    Changchun, China
    Recruiting
  • West China Hospital of Sichuan University
    Chengdu, 610041, China
    Recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, 510080, China
    Recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, 150081, China
    Recruiting
  • Shandong Cancer Hospital
    Jinan, 250117, China
    Recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, 330008, China
    Recruiting
  • The First Affiliated Hospital of Ningbo University
    Ningbo, 315000, China
    Recruiting
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, 200025, China
    Recruiting
  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, 200233, China
    Recruiting
  • Tianjin Cancer Hospital
    Tianjin, 300060, China
    Recruiting
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, 325035, China
    Recruiting
  • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
    Wuhan, 430022, China
    Recruiting
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
    Wuhan, 430030, China
    Recruiting
  • The First Affiliated Hospital of Xian Jiao Tong University
    Xi'an, 710061, China
    Recruiting
  • Yantai Yu Huangding Hospital
    Yantai, 264099, China
    Recruiting
  • Henan Cancer Hospital
    Zhengzhou, 450008, China
    Recruiting
  • Prince of Wales Hospital
    Hong Kong, Hong Kong
    Recruiting
  • Queen Mary Hospital
    Hong Kong, Hong Kong
    Recruiting
07

References and documents

08

Registry details

Key details

Study ID
NCT07200375
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Oct 1, 2025
Start date
Sep 29, 2025
Primary completion
Sep 29, 2029 (estimated)
Completion
Sep 29, 2029 (estimated)
Last update
Sep 8, 2026

Study contacts

Reference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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