drugset / Trial / NCT03311126

Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma

NCT03311126 ↗

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

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Obinutuzumab Monoclonal antibody 1000 mg —

Indications