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NCT03671018 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
A Phase 1 study of B-Cell Non-Hodgkin Lymphoma, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 1
- Development phase
- 422
- Enrollment target
- 20
- Study locations
NCT03671018 is a Phase 1 study of B-Cell Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 422 participants, above the 112-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (277% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT03671018, a Phase 1 study of B-Cell Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 422 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Polatuzumab vedotin
- DRUG Tocilizumab
- DRUG Mosunetuzumab (IV)
- DRUG Mosunetuzumab (SC)
Study Locations (20)
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
- Fox Chase Cancer Center - Philadelphia
- University of Pittsburgh - Hillman Cancer Center - Pittsburgh
Other
- UZ Brussel - Brussels
- CH Jolimont - Lobbes (Jolimont) - Haine-Saint-Paul
- Clinique St Pierre asbl - Ottignies
Florida
- University of Miami Miller School of Medicine - Miami
- Moffitt Cancer Center - Tampa
Michigan
- University of Michigan Hospital - Ann Arbor
- Karmanos Cancer Institute - Detroit
Alabama
- University of Alabama at Birmingham School of Medicine - Birmingham
California
- City of Hope - Duarte
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora
New York
- New York University Langone Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2025-07-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03671018
The ClinicalTrials.gov registry entry for NCT03671018 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 422 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 112-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (277% 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 B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.
NCT03671018 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Pennsylvania, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT03671018 about?
NCT03671018 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma". This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lym...
What is the current status of trial NCT03671018?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 422 participants. The study started on 2018-09-25. Estimated completion is 2025-07-20.
What conditions does trial NCT03671018 study?
This clinical trial studies the following conditions: B-Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT03671018?
The interventions under investigation include: Rituximab (DRUG), Polatuzumab vedotin (DRUG), Tocilizumab (DRUG), Mosunetuzumab (IV) (DRUG), Mosunetuzumab (SC) (DRUG).
Who is sponsoring clinical trial NCT03671018?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03671018 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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