A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (NCT05091424)
A Phase IB Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
🩺 Plain-English Summary (8th-Grade Level)
This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first three cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Rochester — Rochester, Minnesota
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 (31 Sites)
Showing the first 25 of 31 sites.
- Mayo Clinic Rochester — Rochester, Minnesota
- Memorial Sloan-Kettering Cancer Center — New York, New York
- The James Cancer Hospital and Solove Research Institute — Columbus, Ohio
- Uni of Texas - Md Anderson Cancer Center — Houston, Texas
- Huntsman Cancer Institute at The University of Utah — Salt Lake City, Utah
- Princess Alexandra Hospital Woolloongabba — Woolloongabba, Queensland
- Peter MacCallum Cancer Center — East Melbourne, Victoria
- Monash Medical Centre — Melbourne, Victoria
- Peking University People's Hospital — Beijing,
- Southern Medical University Nanfang Hospital — Guangzhou,
- The First Affiliated Hospital of Nanchang University — Nanchang,
- Tianjin Institute of Hematology & Blood Diseases Hospital — Tianjin,
- Chu de Clermont Ferrand — Clermont-Ferrand,
- IUCT Oncopole — Toulouse,
- Universitätsklinikum Augsburg — Augsburg,
- Uniklinik Koln — Cologne,
- Universitätsklinikum Ulm — Ulm,
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili — Brescia, Lombardy
- Osp. San Raffaele — Milan, Lombardy
- Asst Grande Ospedale Metropolitano Niguarda — Milan, Lombardy
- Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia — Sant'Andrea Delle Fratte (PG), Umbria
- Uniwersyteckie Centrum Kliniczne — Gda?sk,
- PRATIA MCM Kraków — Krakow,
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroc?aw,
- Seoul National University Hospital — Seoul,
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.