drugset / Trial / NCT02600897

A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NCT02600897

Phase 1/2 Completed 114 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL), followed by post-induction treatment with obinutuzumab in combination with lenalidomide in participants with FL who achieve a complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.

Timeline

Start
2016-03-24
Primary completion
2021-12-15
Completion
2021-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 15 mg Oral
Subject Lenalidomide Other / unclassified 20 mg Oral
Subject Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Subject Polatuzumab Vedotin Other / unclassified 1.4 mg/kg Intravenous
Subject Polatuzumab Vedotin Other / unclassified 1.8 mg/kg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous