Glofitamab for Chinese adults with second-line relapsed or refractory diffuse large B‑cell lymphoma
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 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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | Glofitamab |
| Locations | 17 sites (Langfang, Hebei and 16 other locations) |
| Trial ID | NCT07200375 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Langfang, Hebei and 16 other locations
- 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)
- Guangdong Provincial People's Hospital — Guangzhou, China (Recruiting)
- Harbin Medical University Cancer Hospital — Harbin, China (Recruiting)
- Shandong Cancer Hospital — Jinan, China (Recruiting)
- Ruijin Hospital, Shanghai Jiaotong 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)
Study contacts
- Study coordinator: Reference Study ID Number: ML45172 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.