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RecruitingNCT07200375GlofitRealUpdated Nov 5, 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 2026-11-05.

Sponsored by Hoffmann-La Roche · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
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

In context

Lymphoma, Large B-Cell, Diffuse

1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.

This study's planned enrollment of 300 is above the median of 150 across 185 observational studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed R/R DLBCL after one
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

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

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

06

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

07

Study locations

22 of 22 sites recruiting
08

References and documents

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Sep 2029, 48 months after the start.

Of 66 observational studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 114. This study's planned 48 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2025
First posted
Oct 1, 2025
StartActual
Sep 29, 2025
Primary completionEst.
Sep 29, 2029
CompletionEst.
Sep 29, 2029
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
2 updates, last Nov 5, 2026
Show all 2 updates
  1. Nov 5, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 6, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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
Nov 5, 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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