drugset / Trial / NCT03311126
Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
This is a phase II single-arm, open-label, multicenter study evaluating the efficacy and safety of the combination of induction chemoimmunotherapy with bendamustine and obinutuzumab (BO) followed by consolidation therapy and maintenance therapy with obinutuzumab in subjects who have not received prior cytotoxic chemotherapy for their Mantle Cell Lymphoma (MCL) (i.e., prior single agent rituximab is permitted, prior involved-field radiotherapy is permitted).
Timeline
- Start
- 2017-09-29
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
Outcome
Outcome not reported
Stopped (Enrollment): “slow accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | — |