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NCT03677154 · ClinicalTrials.gov registry record · Phase 1

Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma

A Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
188
Enrollment target
20
Study locations

NCT03677154 is a Phase 1 study of Diffuse Large B Cell Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 188 participants, below the 217-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT03677154, a Phase 1 study of Diffuse Large B Cell Lymphoma, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
188 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of stable disease or partial response, or in elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in combination with polatuzumab vedotin IV in elderly/unfit participants with previously untreated DLBCL.

Interventions

  • DRUG Polatuzumab Vedotin
  • DRUG Tocilizumab
  • DRUG Mosunetuzumab Intravenous (IV)
  • DRUG Mosunetuzumab Subcutaneous (SC)

Study Locations (20)

Other

  • Soroka Medical Center - Beersheba
  • Rambam Medical Center - Haifa
  • Carmel medical center - Haifa
  • Shaare Zedek Medical Center - Jerusalem
  • Hadassah Ein-Karem - Jerusalem
  • Meir Medical Center - Kfar Saba
  • Sheba Medical Center - Ramat Gan
  • Uniwersyteckie Centrum Kliniczne - Gdansk
  • PRATIA MCM Kraków - Krakow
  • Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli - Lublin
  • Szpital Wojewodzki w Opolu - Opole
  • Pusan National University Hospital - Busan

Alabama

  • University of Alabama at Birmingham School of Medicine - Birmingham

California

  • University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica - Santa Monica

Indiana

  • Fort Wayne Medical Institute - Fort Wayne

Maryland

  • University of Maryland Medical Center - Baltimore

North Carolina

  • Duke University - Durham

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Rhode Island

  • Rhode Island Hospital - Providence

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2019-05-23
Est. Completion 2025-08-07
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT03677154

The ClinicalTrials.gov registry entry for NCT03677154 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (13% lower). 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 Polatuzumab Vedotin is the first listed.

NCT03677154 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT03677154 about?

NCT03677154 is a clinical study titled "Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma". This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of stable disease or partial response, or in elderly/unfit participants with previously ...

What is the current status of trial NCT03677154?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 188 participants. The study started on 2019-05-23. Estimated completion is 2025-08-07.

What conditions does trial NCT03677154 study?

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

What interventions are being tested in trial NCT03677154?

The interventions under investigation include: Polatuzumab Vedotin (DRUG), Tocilizumab (DRUG), Mosunetuzumab Intravenous (IV) (DRUG), Mosunetuzumab Subcutaneous (SC) (DRUG).

Who is sponsoring clinical trial NCT03677154?

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

Where is trial NCT03677154 being conducted?

This trial has 20 study locations across Alabama, California, Indiana, Maryland, North Carolina. 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.