A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
Public ClinicalTrials.gov record NCT03671018. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03671018
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 422 participants
Conditions and interventions
Conditions
Interventions
- Mosunetuzumab (IV) Drug
- Mosunetuzumab (SC) Drug
- Polatuzumab vedotin Drug
- Tocilizumab Drug
- Rituximab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 25, 2018 (Actual)
- Primary completion
- Jan 30, 2024 (Actual)
- Completion
- Jul 20, 2025 (Estimated)
- Last update posted
- Nov 29, 2024
2018 – 2025
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine | Birmingham | Alabama | 35249 | — |
| City of Hope | Duarte | California | 91010 | — |
| University of Colorado Hospital - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232-1301 | — |
| Lifespan Cancer Institute | Providence | Rhode Island | 02905 | — |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| Medical College of Wisconsin, Froedtert Hospital;Nephrology Section | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03671018, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 29, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03671018 live on ClinicalTrials.gov.