drugset / Trial / NCT03255096

A Study to Evaluate Safety, Pharmacokinetics, and Clinical Activity of Combination of RO6870810 and Venetoclax, With or Without Rituximab, in Participants With Relapsed/Refractory DLBCL and/or High-Grade B-Cell Lymphoma and/or High Grade B-Cell Lymphoma With MYC and/or BCL2 and/or BCL6

NCT03255096

Phase 1 Completed 39 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability and clinical activity of RO6870810 in combination with venetoclax and when co-administered with rituximab in participants with relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and/or high-grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and/or B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) gene rearrangements (HGBL-DH/TH).

Timeline

Start
2017-08-28
Primary completion
2019-07-03
Completion
2019-07-03

Drugs

EvaluationDrugModalityDoseRoute
Subject RO6870810 Small molecule 0.3 mg/kg Subcutaneous
Subject RO6870810 Small molecule 0.45 mg/kg Subcutaneous
Subject RO6870810 Small molecule 0.65 mg/kg Subcutaneous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Venetoclax Small molecule 400 mg Oral