CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 270 enrolled
Drug / intervention
Polatuzumab Vedotin +3 moredrug
Likely dose
Polatuzumab vedotin 1.8 mg/kg (maximum 240 mg/cycle) IV on Day 1 of each 21-day cycle for up to 8 cycles in combination with rituximab 375 mg/m2, gemcitabine 1000 mg/m2, and oxaliplatin 100 mg/m2AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed DLBCL NOS or transformed indolent disease
  • ✓Relapsed disease (≥6 month response duration before recurrence) or refractory disease (no response or progression during/within 6 months of prior therapy)
  • ✓At least 1 prior line of systemic therapy (HSCT, CAR-T, or chemotherapy each count as separate lines; local therapy does not)
  • ✓At least one bi-dimensionally measurable lesion >1.5 cm in longest dimension by CT or MRI
Key exclusion· 11
  • ✕Severe allergic or anaphylactic reactions to humanized/murine monoclonal antibodies or known sensitivity to murine products
  • ✕Contraindication to rituximab, gemcitabine, or oxaliplatin
  • ✕Peripheral neuropathy >Grade 1 per NCI CTCAE v5.0
  • ✕Prior polatuzumab vedotin or gemcitabine plus platinum combination therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04182204
NCT04182204Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Dec 2, 2019·Updated Dec 22, 2025

In Brief

A Phase 3 clinical trial evaluating Polatuzumab Vedotin, Rituximab, and 2 other interventions for Diffuse Large B-Cell Lymphoma. Completed, enrolled 270 participants across 62 sites in 16 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-Cell Lymphoma
CountriesBrazil, Canada, China, Finland, France, Germany, Greece, India, Ireland, Italy, Mexico, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2, 2019
Enrollment StartFeb 7, 2020
Primary CompletionNov 29, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 6.6 years ago

Interventions

Polatuzumab Vedotindrug

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.

Rituximabdrug

Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.

Gemcitabinedrug

Gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.

Oxaliplatindrug

Oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.