Completed
PHASE3
INTERVENTIONAL
NCT04182204
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).
Detailed Description
The safety run-in stage (Stage 1) will assess the safety of polatuzumab vedotin plus rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx) in 10 participants. The randomized controlled trial (RCT) (Stage 2) will compare Pola-R-GemOx versus R-GemOx alone using overall survival (OS). This is an event-driven trial.
Interventions
Name:
Polatuzumab Vedotin
Type:
DRUG
Description:
Polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.
Name:
Rituximab
Type:
DRUG
Description:
Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
Name:
Gemcitabine
Type:
DRUG
Description:
Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
Name:
Oxaliplatin
Type:
DRUG
Description:
Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
Primary Outcomes
Measure:
Stage 1: Percentage of Participants with Adverse Events (AEs)
TimeFrame:
From baseline until 90 days after last dose (up to approximately 55 months)
Description:
Measure:
Stage 2: Overall Survival (OS)
TimeFrame:
From randomization in RCT up to approximately 34 months
Description:
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Trial Information
NCT ID
NCT04182204
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Hoffmann-La Roche
Last Updated
December 15, 2025