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NCT04408638 · ClinicalTrials.gov registry record · Phase 3

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

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

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

NCT04408638 is a Phase 3 study of Diffuse Large B Cell Lymphoma that is active but no longer recruiting, 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 14 states.

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The verdict

NCT04408638, a Phase 3 study of Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
270 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

Interventions

  • DRUG Obinutuzumab
  • DRUG Glofitamab
  • DRUG Gemcitabine
  • DRUG Tocilizumab
  • DRUG Rituxumab

Study Locations (20)

Other

  • UZ Leuven Gasthuisberg - Leuven
  • CHU de Liège (Sart Tilman) - Liège
  • Peking University Third Hospital - Beijing
  • Sun Yet-sen University Cancer Center - Guangzhou

Victoria

  • Monash Health Monash Medical Centre - Clayton
  • St Vincent's Hospital Melbourne - Fitzroy
  • Peter Maccallum Cancer Centre - Melbourne

Maryland

  • University of Maryland Medical Center - Baltimore
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore

Alabama

  • University of Alabama at Birmingham - Birmingham

California

  • Community Cancer Institute (CCI) - Fresno

Florida

  • Baptist - MD Anderson Cancer Center - Jacksonville

Massachusetts

  • Massachusetts General Hospital - Boston

Mississippi

  • University of Mississippi Medical Center - Jackson

Trial Details

FieldValue
Enrollment Target 270 participants
Start Date 2021-02-23
Est. Completion 2028-03-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT04408638

The ClinicalTrials.gov registry entry for NCT04408638 describes a study currently listed as active not recruiting, 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 5 interventions - of which Obinutuzumab is the first listed.

NCT04408638 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Victoria, Maryland.

Frequently Asked Questions

What is clinical trial NCT04408638 about?

NCT04408638 is a clinical study titled "A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma". This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

What is the current status of trial NCT04408638?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2021-02-23. Estimated completion is 2028-03-31.

What conditions does trial NCT04408638 study?

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

What interventions are being tested in trial NCT04408638?

The interventions under investigation include: Obinutuzumab (DRUG), Glofitamab (DRUG), Gemcitabine (DRUG), Tocilizumab (DRUG), Rituxumab (DRUG).

Who is sponsoring clinical trial NCT04408638?

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

Where is trial NCT04408638 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Maryland, Massachusetts. 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.