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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
Sponsor: Hoffmann-La Roche
Summary
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). 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 two 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
137
Start Date
2022-03-07
Completion Date
2030-02-28
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Mosunetuzumab
Participants will receive subcutaneous (SC) mosunetuzumab
Tocilizumab
Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.
Venetoclax
Participants will receive daily oral venetoclax
Locations (31)
Mayo Clinic Rochester
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Uni of Texas - Md Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Center
East Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Peking University People's Hospital
Beijing, China
Southern Medical University Nanfang Hospital
Guangzhou, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Tianjin Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Chu de Clermont Ferrand
Clermont-Ferrand, France
IUCT Oncopole
Toulouse, France
Universitätsklinikum Augsburg
Augsburg, Germany
Uniklinik Koln
Cologne, Germany
Universitätsklinikum Ulm
Ulm, Germany
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, Italy
Osp. San Raffaele
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Sant'Andrea Delle Fratte (PG), Umbria, Italy
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland
PRATIA MCM Kraków
Krakow, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, Poland
Seoul National University Hospital
Seoul, South Korea
Seoul St Mary's Hospital
Seoul, South Korea
Yeouido St. Mary's Hospital
Seoul, South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Christie Hospital NHS Trust
Manchester, United Kingdom
Churchill Hospital
Oxford, United Kingdom