GO39942 (POLARIX) (FL)
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 (POLARIX)
Study treatments
- Experimental arm: polatuzumab vedotin 1.8 mg/kg intravenously (IV), placebo for vincristine IV, rituximab 375 mg/m² IV, cyclophosphamide 750 mg/m² IV, and doxorubicin 50 mg/m² IV on Day 1 and prednisone 100 mg/day orally on Days 1-5 of every 21-day cycle for 6 cycles
- Standard arm: placebo for polatuzumab vedotin, rituximab 375 mg/m² IV, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV on Day 1 and prednisone 100 mg/day orally on Days 1-5 of every 21-day cycle for 6 cycles
Inclusion criteria
- Previously untreated participants with cluster of differentiation 20 (CD20)-positive DLBCL
- IPI score of 2-5
- ECOG score 0-2
- Left ventricular ejection fraction >/= 50 % on MUGA scan or echo cardio
Exclusion criteria
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- Prior organ transplantation
- Current Grade greater than 1 peripheral neuropathy by clinical examination
- History of indolent lymphoma
- History of follicular lymphoma grade 3B
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma)
- Primary mediastinal (thymic) large B-cell lymphoma
- Burkitt lymphoma
- Prior therapy for DLBCL, with the exception of nodal biopsy
Participating sites
- Ghent University Hospital
- Centres Hospitaliers de Jolimont
- CHU UCL Namur site Mont-Godinne
- Institut Jules Bordet
- CHU UCL Cliniques Universitaires St-Luc