Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05091424
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Mosunetuzumab

Participants will receive subcutaneous (SC) mosunetuzumab

DRUG

Tocilizumab

Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events.

DRUG

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