drugset / Trial / NCT05605899
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
Timeline
- Start
- 2023-02-10
- Primary completion
- 2031-03
- Completion
- 2031-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Axicabtagene Ciloleucel | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 10 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Prednisone | Other / unclassified | 40 mg/m2 | Oral |
| Comparator | Prednisone | Other / unclassified | 60 mg/m2 | Oral |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 0.4 mg/m2 | Intravenous |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |