Evaluating glofitamab for patients with relapsed or refractory DLBCL in China
A Study to Evaluate Glofitamab as Single Agent in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
This study is testing if glofitamab can safely help Chinese patients with relapsed or refractory diffuse large B-cell lymphoma who haven't responded to previous treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | glofitamab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06481826 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of glofitamab as a single-agent treatment for Chinese patients diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have not responded to at least two prior systemic therapies. Participants must have measurable disease and a confirmed histological diagnosis of DLBCL. The study will focus on patients who meet specific inclusion criteria while excluding those with certain health conditions that may interfere with treatment.
Who should consider this trial
Good fit: Ideal candidates are Chinese patients with relapsed or refractory DLBCL who have failed two or more lines of systemic therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have active infections or severe organ failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat DLBCL.
How similar studies have performed: While this specific approach is being evaluated in this study, similar treatments have shown promise in other studies involving glofitamab for DLBCL.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically-confirmed DLBCL 2. Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy 3. Participants must have measurable disease Exclusion Criteria: 1. Pregnancy or breastfeeding 2. Patient with known active infection, or reactivation of a latent infection 3. Patient with active autoimmune disease or immune deficiency 4. severe organ failure：LVEF\<40%；DLCO\<40%；eGFR\<30ml/min；Bilirubin≥3ULN 5. Patients who are dependent on the sponsor, the investigator or the trial site
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jing Ruan
- Email: 15201435860@163.com
- Phone: +8615201435860
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.