Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL
The objective of this study is to evaluate the efficacy and safety of the Glofitamab bridging ASCT regimen in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and to provide better clinical benefits to these patients.
| Condition(s) | Diffuse Large B-cell Lymphoma(DLBCL) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The objective of this study is to evaluate the efficacy and safety of the Glofitamab bridging ASCT regimen in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and to provide better clinical benefits to these patients. |
| Who can participate | Inclusion Criteria: 1. Patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathology/cytology using the 2022 World Health Organization (WHO) Classification of Diseases; 2. Patients with R/R DLBCL who have received at least two lines of systemic treatment; 3. Age range: 18-70 years old, male or female not limited; 4. When the disease recurs or is difficult to treat, there are assessable lesions (lymph node diameter ≥ 1.0cm; or skin lesions assessable by physical examination); 5. Expected lifespan\>3 months; 6. No previous transplantation treatment has been performed; 7. ECOG score 0-1 points; 8. Appropriate organ function: Cardiac function: ejection fraction ≥ 50%, asymptomatic arrhythmia; Liver function: alanine aminotransferase and aspartate aminotransferase ≤ 2 times th |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Soochow University |
| Locations | Suzhou, Jiangsu, China |
| Start date | 2024-11-10 |
| NCT ID | NCT06682130 |
| Official listing | https://clinicaltrials.gov/study/NCT06682130 |