NCT03311126

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

Bendamustine + Obinutuzumab Induction Chemoimmunotherapy With Risk-adapted Obinutuzumab Maintenance Therapy in Previously Untreated Mantle Cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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 MCL (i.e., prior single-agent rituximab is permitted, prior involved-field radiotherapy is permitted). Therapy for individual subjects will be risk-adapted based on results of minimal residual disease (MRD) testing performed after the consolidation phase. The study will be carried out at the University of Wisconsin Carbone Cancer Center (UWCCC) and participating community and academic practice sites within the Wisconsin Oncology Network (WON). There will be 6-10 sites participating in this study. The subject participation will include a screening period, treatment period, and a follow-up period. The induction chemoimmunotherapy regimen consists of bendamustine and obinutuzumab for 4-6 cycles, followed by consolidation and maintenance therapy with obinutuzumab in subjects achieving an objective response to induction therapy (i.e., complete or partial response; stable disease with objective evidence of tumor shrinkage. Subjects who are MRD-negative (determined by MRD testing on bone marrow and PB) after consolidation therapy will omit maintenance therapy. Subjects will undergo disease reassessment after C4 of induction BO chemoimmunotherapy, after obinutuzumab consolidation therapy, and after C4 and C8 of maintenance obinutuzumab. MRD testing will be done after C2 of induction (PB only), after consolidation (BMA and PB), and post-maintenance or end of treatment (EOT) (PB only).

Conditions

• Mantle Cell Lymphoma
• Non-hodgkin Lymphoma
• Non Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine	Bendamustine is a chemotherapeutic agent that has dual functional properties of both an alkylating agent and a nitrogen mustard. Through these unique cytostatic properties, bendamustine is able to inhibit DNA transcription, replication, and repair. Bendamustine is approved in the U.S. for treatment of chronic lymphocytic leukemia (CLL) and for indolent B cell non-Hodgkin lymphomas (NHLs) progressing during or within 6 months of rituximab or a rituximab - containing regimen.
DRUG	Obinutuzumab	Obinutuzumab is a glycoengineered, humanized, type II anti-CD20 monoclonal antibody (mAb).

Timeline

• Start date: 2017-09-29
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2017-10-16
• Last updated: 2024-10-24
• Results posted: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study