Diffuse Large B-Cell LymphomaGlofitRealNCT07200375
An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 22 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Glofitamab
- How many people
- 300 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 29 Sep 2025to 29 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Participants who currently participate in or plan to participate in any interventional clinical trial
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
22 sites in 2 countries
China20 sites, 20 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
- Recruiting
Peking University Third Hospital
Beijing, 100191
- Recruiting
The First Bethune Hospital of Jilin University
Changchun
- Recruiting
West China Hospital of Sichuan University
Chengdu, 610041
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, 510080
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences.
Langfang, Hebei, 065001
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, 330008
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, 315000
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200233
- Recruiting
Chinese Academy of Medical Sciences Hematology Hospital;Lymphoma Diagnosis and Treatment Center
Tianjin, Tianjin Municipality, 301636
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300060
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325035
- Recruiting
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430022
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, 430030
- Recruiting
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061
- Recruiting
Yantai Yu Huangding Hospital
Yantai, 264099
- Recruiting
Henan Cancer Hospital
Zhengzhou, 450008
Hong Kong2 sites, 2 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
- Recruiting
Queen Mary Hospital
Hong Kong
About this study
Official 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
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).
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Glofitamab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabDrug
Participants will receive glofitamab as part of a cancer-treatment regimen in a real-world setting. No intervention will be administered by study investigators.
| Study group | Role | What they receive |
|---|---|---|
| Glofitamab treatment | Participants will be enrolled into the study either prior to initiation of glofitamab therapy or within 90 days of starting glofitamab therapy. Receives: Drug: Glofitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
real-world Progression-Free Survival (rwPFS)
Measured: Up to approximately 4 years
Secondary outcomes (8)
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
Measured: Up to approximately 4 years
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
Measured: Up to approximately 4 years
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
Measured: Up to approximately 4 years
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
Measured: Up to approximately 4 years
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
Measured: Up to approximately 4 years
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
Measured: Up to approximately 4 years
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
Measured: Up to approximately 4 years
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
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start29 Sep 2025
- Primary completion29 Sep 2029 (estimated)
- Study completion29 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200375
- Sponsor's protocol ID
- ML45172
- Acronym
- GlofitReal
- Status last verified
- Nov 2026
- First submitted
- 23 Sep 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07200375
- Acronym / sponsor ID
- GlofitReal / ML45172
- Conditions
- Diffuse Large B-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 29 Sep 2029 (estimated)
- Study completion
- 29 Sep 2029 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glofitamab treatment | – | Drug: GlofitamabParticipants will be enrolled into the study either prior to initiation of glofitamab therapy or within 90 days of starting glofitamab therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who currently participate in or plan to participate in any interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlofitamabParticipants will receive glofitamab as part of a cancer-treatment regimen in a real-world setting. No intervention will be administered by study investigators. | Drug | Glofitamab treatment |
Primary outcome
real-world Progression-Free Survival (rwPFS)
Time frame: Up to approximately 4 years
8 secondary outcomes
Complete Response Rate (CRR)
Time frame: Up to approximately 4 years
Overall Response Rate (ORR)
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
Time frame: Up to approximately 4 years
Duration of Response (DoR)
Time frame: Up to approximately 4 years
Duration of Complete Response (DoCR)
Time frame: Up to approximately 4 years
Overall Survival (OS)
Time frame: Up to approximately 4 years
Event-Free Survival (EFS)
Time frame: Up to approximately 4 years
Time to Next Treatment (TTNT)
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
real-world Progression-Free Survival (rwPFS) (time frame: Up to approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.