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NCT03677141 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
A Phase 1 study of B-Cell Non-Hodgkin Lymphoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
- 20
- Study locations
NCT03677141 is a Phase 1 study of B-Cell Non-Hodgkin Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 117 participants, roughly in line with the 125-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target. The trial reports 20 study locations across 14 states.
The verdict
NCT03677141, a Phase 1 study of B-Cell Non-Hodgkin Lymphoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Mosunetuzumab
- DRUG Doxorubicin
- DRUG Polatuzumab Vedotin
- DRUG Rituxumab
Study Locations (20)
Other
- Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU - Salzburg
- LKH Steyr - Steyr
- Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien - Vienna
- Hanusch-Krankenhaus - Vienna
- CHU Henri Mondor; Service d'Oncologie Medicale - Créteil
California
- University of California; Moores Cancer Center - La Jolla
- University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica - Santa Monica
Texas
- The University of Texas MD Anderson Cancer Center - Houston
- Scott and White Hospital; Cancer Center - Temple
Alabama
- University of Alabama Birmingham - Birmingham
Arizona
- Banner MD Anderson Cancer Center - Gilbert
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Florida
- University of Miami Miller School of Medicine - Miami
Kansas
- University of Kansas Cancer Center - Westwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2019-03-08 |
| Est. Completion | 2023-10-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03677141
The ClinicalTrials.gov registry entry for NCT03677141 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 125-participant average among 24 other B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target. 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 Cyclophosphamide is the first listed.
NCT03677141 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT03677141 about?
NCT03677141 is a clinical study titled "A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma". This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin...
What is the current status of trial NCT03677141?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2019-03-08. Estimated completion is 2023-10-12.
What conditions does trial NCT03677141 study?
This clinical trial studies the following conditions: B-Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT03677141?
The interventions under investigation include: Cyclophosphamide (DRUG), Mosunetuzumab (DRUG), Doxorubicin (DRUG), Polatuzumab Vedotin (DRUG), Rituxumab (DRUG).
Who is sponsoring clinical trial NCT03677141?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03677141 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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