A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma (NCT03671018)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham School of Medicine — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (29 Sites)
Showing the first 25 of 29 sites.
- University of Alabama at Birmingham School of Medicine — Birmingham, Alabama
- City of Hope — Duarte, California
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado
- University of Miami Miller School of Medicine — Miami, Florida
- Moffitt Cancer Center — Tampa, Florida
- University of Michigan Hospital — Ann Arbor, Michigan
- Karmanos Cancer Institute — Detroit, Michigan
- New York University Langone Medical Center — New York, New York
- Levine Cancer Institute — Charlotte, North Carolina
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- University of Pittsburgh - Hillman Cancer Center — Pittsburgh, Pennsylvania
- Lifespan Cancer Institute — Providence, Rhode Island
- University of Texas M.D. Anderson Cancer Center — Houston, Texas
- Fred Hutchinson Cancer Research Center — Seattle, Washington
- Medical College of Wisconsin, Froedtert Hospital;Nephrology Section — Milwaukee, Wisconsin
- UZ Brussel — Brussels,
- CH Jolimont - Lobbes (Jolimont) — Haine-Saint-Paul,
- Clinique St Pierre asbl — Ottignies,
- Hamilton Health Sciences - Juravinski Cancer Centre — Hamilton, Ontario
- Jewish General Hospital — Montreal, Quebec
- Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC) — Saskatoon, Saskatchewan
- Institut Catala d Oncologia Hospital Duran i Reynals — Barcelona,
- Hospital de San Pedro de Alcantara — Cáceres,
- Hospital General Universitario Gregorio Marañon — Madrid,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in B-cell Non-Hodgkin Lymphoma
- Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma — Chicago, Illinois
- Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma — Seattle, Washington
- A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) — Clovis, California
- DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas — Miami, Florida
- Tailored Prednisone Reduction in Preventing Hyperglycemia in Participants With B-Cell Non-Hodgkin Lymphoma Receiving Combination Chemotherapy Treatment — Winston-Salem, North Carolina
Explore by condition: All B-cell Non-Hodgkin Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.