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NCT04182204 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Diffuse Large B Cell Lymphoma, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
270
Enrollment target
20
Study locations

NCT04182204 is a Phase 3 study of Diffuse Large B Cell Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 270 participants, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT04182204, a Phase 3 study of Diffuse Large B Cell Lymphoma, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
270 participants
Enrollment target
20
Study locations

Study 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).

Interventions

  • DRUG Oxaliplatin
  • DRUG Rituximab
  • DRUG Gemcitabine
  • DRUG Polatuzumab Vedotin

Study Locations (20)

Other

  • Hu Nan Provincial Cancer Hospital - Changsha
  • West China Hospital - Sichuan University - Chengdu
  • Cancer Center, Sun Yat-sen University of Medical Sciences - Guangzhou
  • The 1st Affiliated Hospital of Nanchang Unversity - Nanchang
  • Guangxi Cancer Hospital of Guangxi Medical University - Nanning
  • Institute of Hematology and Hospital of Blood Disease - Tianjin

Florida

  • Cancer Specialists - Jacksonville
  • Memorial Cancer Institute at Memorial West - Pembroke Pines

New Jersey

  • MSKCC at Basking Ridge - Basking Ridge
  • Memorial Sloan Kettering Cancer Center at Bergen - Montvale

New York

  • Memorial Sloan-Kettering Cancer Center - New York
  • Memorial Sloan Kettering Nassau - Uniondale

Ontario

  • London Health Sciences Centre - London
  • Niagara Health Systems - St. Catherines General Site - St. Catharines

Michigan

  • IHA Hematology Oncology Consultants - Ann Arbor - Ann Arbor

Estado de Bahia

  • Hospital Sao Rafael - HSR - Salvador

Rio Grande do Norte

  • Liga Norte Riograndense Contra O Câncer - Natal

Trial Details

FieldValue
Enrollment Target 270 participants
Start Date 2020-02-07
Est. Completion 2024-11-29
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT04182204

The ClinicalTrials.gov registry entry for NCT04182204 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (25% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Oxaliplatin is the first listed.

NCT04182204 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Florida, New Jersey.

Frequently Asked Questions

What is clinical trial NCT04182204 about?

NCT04182204 is a clinical study titled "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". 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 ...

What is the current status of trial NCT04182204?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2020-02-07. Estimated completion is 2024-11-29.

What conditions does trial NCT04182204 study?

This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.

What interventions are being tested in trial NCT04182204?

The interventions under investigation include: Oxaliplatin (DRUG), Rituximab (DRUG), Gemcitabine (DRUG), Polatuzumab Vedotin (DRUG).

Who is sponsoring clinical trial NCT04182204?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04182204 being conducted?

This trial has 20 study locations across Florida, Michigan, New Jersey, New York, Estado de Bahia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.