RecruitingPhase 1NCT05091424

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

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

Sponsor

Hoffmann-La Roche

Enrollment

137 participants

Start Date

Mar 7, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing mosunetuzumab — an antibody that helps the immune system attack cancer cells — with or without venetoclax (another cancer drug) in people with chronic lymphocytic leukemia (CLL) whose disease has come back or stopped responding to previous treatments. **You may be eligible if...** - You have been diagnosed with CLL that has relapsed (come back) or is not responding to current treatment - You are in reasonably good physical health (ECOG score ≤ 2) - Your bone marrow and liver function are adequate - You have a life expectancy of more than 6 months - You are willing to use reliable birth control during and after treatment **You may NOT be eligible if...** - You have had prior treatment with mosunetuzumab, venetoclax, or similar bispecific antibodies - You have active autoimmune disease requiring ongoing treatment - You have active hepatitis B or C - Your organ function does not meet minimum requirements - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMosunetuzumab

Participants will receive subcutaneous (SC) mosunetuzumab

DRUGTocilizumab

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

DRUGVenetoclax

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

View Full Details on ClinicalTrials.gov

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NCT05091424

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