Polivy 140 mg powder for concentrate for solution for infusion.
Sponsors
F. Hoffmann-La Roche AG, GWT-Tud GmbH, Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH, Instytut Hematologii I Transfuzjologii
Conditions
Adult patients with relapsed or primary refractory DLBCLB-cell non-Hodgkin lymphoma (NHL)Diffuse Large B-Cell Lymphoma (DLBCL)Diffuse large B-cell lymphoma) and aggressive B-cell lymphomas (HGBCLDiffuse large B-cell lymphomas (DLBCLHigh-grade B-cell lymphoma) originate from mature B-cells at various stages of terminal differentiationPreviously Untreated Diffuse large B-cell lymphoma (DLBCL)Relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Phase 1
An Open-Label, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in Patients with B-Cell Non-Hodgkin Lymphoma
Active, not recruitingCTIS2023-506986-74-00
Start: 2021-12-27Target: 17Updated: 2025-08-04
A Phase I/II Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients with Diffuse Large B-Cell Lymphoma following First-Line Immunochemotherapy and as Monotherapy or In Combination With Polatuzumab Vedotin in Elderly/Unfit Patients with Previously Untreated Diffuse Large B-Cell Lymphoma
CompletedCTIS2023-507498-16-00
Start: 2019-07-02End: 2025-08-06Target: 39Updated: 2025-07-14
Phase 2
A prospective multicenter phase 2 study of the chemotherapy-light combination of intravenous rituximab with the antibody-drug conjugate polatuzumab vedotin and the bispecific antibody glofitamab in previously untreated aggressive B-cell lymphoma patients above 60 years of age ineligible for a fully dosed R-CHOP
Active, not recruitingCTIS2024-513949-37-00
Start: 2023-03-16Target: 125Updated: 2024-11-13
A phase II efficacy and safety study of cell-free circulating tumor DNA-guided commencement of second-line treatment in patients with DLBCL/HGBCL relapse
Not yet recruitingCTIS2024-518275-64-00
Target: 340Updated: 2025-11-24
Phase 3
An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL)
CompletedCTIS2023-508259-38-00
Start: 2021-04-29End: 2025-12-19Target: 302Updated: 2025-11-05
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination with Rituximab Plus Gemcitabine Plus Oxaliplatin (R- GEMOX) Versus R- GEMOX Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
CompletedCTIS2024-512537-33-00
Start: 2019-11-28End: 2024-07-23Target: 49Updated: 2024-09-12
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL COMPARING THE EFFICACY AND SAFETY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB AND CHP (R-CHP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA
RecruitingCTIS2024-516904-40-00
Start: 2018-03-27Target: 356Updated: 2025-10-23