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

ClinicalTrials.gov ID: NCT04182204

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT04182204
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 270 participants

Conditions and interventions

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 7, 2020 (Actual)
Primary completion: Nov 29, 2024 (Actual)
Completion: Nov 29, 2024 (Actual)
Last update posted: Dec 22, 2025

2020 – 2024

United States locations

U.S. sites: 7
U.S. states: 4
U.S. cities: 7

Facility	City	State	ZIP	Site status
Cancer Specialists	Jacksonville	Florida	32256	—
Memorial Cancer Institute at Memorial West	Pembroke Pines	Florida	33028	—
IHA Hematology Oncology Consultants - Ann Arbor	Ann Arbor	Michigan	48106	—
MSKCC at Basking Ridge	Basking Ridge	New Jersey	07920	—
Memorial Sloan Kettering Cancer Center at Bergen	Montvale	New Jersey	07645	—
Memorial Sloan-Kettering Cancer Center	New York	New York	10065	—
Memorial Sloan Kettering Nassau	Uniondale	New York	11553	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04182204, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 22, 2025 · Synced Nov 14, 2026