drugset / Trial / NCT06284122
Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
Phase 3
Recruiting
790 enrolled
The Lymphoma Academic Research Organisation
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · collabLymphoma Study Association · collabSwiss Cancer Institute · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.
Timeline
- Start
- 2024-06-07
- Primary completion
- 2028-11
- Completion
- 2034-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustin | Unknown | 90 mg/m2 | — |
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Subject | Lenalidomide | Other / unclassified | — | — |
| Subject | Mosunetuzumab | Monoclonal antibody | 45 mg | — |
| Comparator | Obinutuzumab | Monoclonal antibody | 1000 mg | — |
| Comparator | Prednisone | Other / unclassified | 100 mg | — |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 1400 mg | Intravenous |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | — |