Glofitamab for Chinese adults with second-line relapsed or refractory diffuse large B‑cell lymphoma
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
Run by Hoffmann-La Roche · NCT07200375 · Data updated 2026-11-12
This will test whether glofitamab-based therapy helps and is safe for Chinese adults whose diffuse large B‑cell lymphoma returned or didn't respond after one prior treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | Glofitamab |
| Locations | 22 sites (Langfang, Hebei and 21 other locations) |
| Status | Recruiting |
| Started | September 29, 2025 |
| Main results expected | September 29, 2029 |
| Study ends | September 29, 2029 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07200375 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults in China with histologically confirmed DLBCL that relapsed or was refractory after one systemic therapy who plan to receive or started a glofitamab-based regimen within the prior 90 days and are not enrolled in another interventional trial.
✕Probably not a fit
Patients enrolled in other interventional trials, those with lymphoma types other than DLBCL, or those who started glofitamab more than 90 days before screening are unlikely to be eligible or to benefit from this observational protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows Chinese adults with relapsed or refractory diffuse large B‑cell lymphoma who are starting or have recently started a glofitamab-based regimen. Eligible participants must have histologically confirmed disease after one prior systemic therapy and either plan to receive glofitamab at consent or have begun it within 90 days before enrollment. The study collects routine clinical data on treatment responses, adverse events, and real-world outcomes without assigning or modifying standard clinical care. Enrollment occurs at major cancer centers in China and excludes people participating in other interventional trials.
Why it matters
Potential benefit: If successful, the findings could support glofitamab as a safe and effective second-line option for Chinese patients with relapsed or refractory DLBCL.
How similar studies have gone: Early clinical trials of glofitamab and other CD20×CD3 bispecific antibodies have shown promising response rates in relapsed/refractory B‑cell lymphomas, so this work extends prior clinical experience to Chinese second-line patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Cancer Hospital Chinese Academy of Medical Sciences.
Langfang, Hebei, China Recruiting -
Chinese Academy of Medical Sciences Hematology Hospital;Lymphoma Diagnosis and Treatment Center
Tianjin, Tianjin Municipality, China Recruiting -
Peking University People's Hospital
Beijing, China Recruiting -
Peking University Third Hospital
Beijing, China Recruiting -
The First Bethune Hospital of Jilin University
Changchun, China Recruiting -
West China Hospital of Sichuan University
Chengdu, China Recruiting
Show 16 more locations
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Guangdong Provincial People's Hospital
Guangzhou, China Recruiting -
Harbin Medical University Cancer Hospital
Harbin, China Recruiting -
Shandong Cancer Hospital
Jinan, China Recruiting -
The Second Affiliated Hospital of Nanchang University
Nanchang, China Recruiting -
The First Affiliated Hospital of Ningbo University
Ningbo, China Recruiting -
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China Recruiting -
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China Recruiting -
Tianjin Cancer Hospital
Tianjin, China Recruiting -
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China Recruiting -
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, China Recruiting -
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China Recruiting -
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, China Recruiting -
Yantai Yu Huangding Hospital
Yantai, China Recruiting -
Henan Cancer Hospital
Zhengzhou, China Recruiting -
Prince of Wales Hospital
Hong Kong, Hong Kong Recruiting -
Queen Mary Hospital
Hong Kong, Hong Kong Recruiting
Study contacts
- Study coordinator: Reference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL
A group of elderly patients with newly diagnosed diffuse large B-cell lymphoma will try a lighter chemotherapy approach using three targeted drugs to see if it works and is safe.
-
Combining radiation therapy with lenalidomide and glofitamab for treating relapsed DLBCL
This study is testing a new treatment combining radiation therapy with lenalidomide and glofitamab to see if it helps people with relapsed diffuse large B-cell lymphoma who haven't responded to other treatments.
-
Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL
This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.
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Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL
This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.
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Non-Hodgkin Lymphoma Sample Collection for MRD Testing
This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.
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Hypofractionated Radiotherapy plus GM-CSF, Pomalidomide and Glofitamab for Newly Diagnosed PCNS-DLBCL
This study tests a combination therapy—hypofractionated radiotherapy with GM-CSF, pomalidomide, and glofitamab—for adults newly diagnosed with primary CNS DLBCL to see if it helps control the disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.