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NCT04231877 · ClinicalTrials.gov registry record · Phase 1

Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

A Phase 1 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by University of Washington.

Recruiting
Registry status
Phase 1
Development phase
56
Enrollment target
1
Study location

NCT04231877 is a Phase 1 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified that is actively recruiting participants, run by University of Washington. The registered enrollment target is 56 participants, roughly in line with the 57-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT04231877, a Phase 1 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, is actively recruiting participants, sponsored by University of Washington.

RECRUITING
Registry status
Phase 1
Development phase
56 participants
Enrollment target
1
Study location

Study Summary

This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.

Interventions

  • DRUG Doxorubicin
  • DRUG Etoposide
  • DRUG Prednisone
  • BIOLOGICAL Rituximab
  • DRUG Polatuzumab Vedotin

Study Locations (1)

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2020-10-27
Est. Completion 2031-12-01
Phase Phase 1

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT04231877

The ClinicalTrials.gov registry entry for NCT04231877 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 57-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Primary Mediastinal Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin is the first listed.

NCT04231877 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT04231877 about?

NCT04231877 is a clinical study titled "Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma". This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a mono...

What is the current status of trial NCT04231877?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2020-10-27. Estimated completion is 2031-12-01.

What conditions does trial NCT04231877 study?

This clinical trial studies the following conditions: Primary Mediastinal Large B Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, Aggressive Non-Hodgkin Lymphoma.

What interventions are being tested in trial NCT04231877?

The interventions under investigation include: Doxorubicin (DRUG), Etoposide (DRUG), Prednisone (DRUG), Rituximab (BIOLOGICAL), Polatuzumab Vedotin (DRUG).

Who is sponsoring clinical trial NCT04231877?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04231877 being conducted?

This trial has 1 study location across Washington. 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.