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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |