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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Diagnoza przewlekłej białaczki limfocytowej (CLL), która wymaga leczenia.
- •Ogólny stan zdrowia pozwalający na udział w badaniu (oceniany skalą ECOG do 2).
- •Dobra praca szpiku kostnego i narządów (wątroby), niezwiązana z samą chorobą.
- •Oczekiwana długość życia powyżej 6 miesięcy.
- •Kobiety w wieku rozrodczym muszą stosować skuteczną antykoncepcję.
- •Mężczyźni muszą stosować prezerwatywy i nie oddawać nasienia.
✗ Disqualifies
- •Ciąża lub karmienie piersią, lub planowanie ciąży w trakcie badania.
- •Wcześniejsze leczenie mosunetuzumabem lub podobnymi lekami.
- •Leczenie innymi lekami o działaniu podobnym do wenetolaksu w ciągu ostatniego miesiąca.
- •Złe rokowania, które mogą wpłynąć na bezpieczeństwo lub skuteczność leczenia.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (31)
Mayo Clinic Rochester
Rochester, United States
Memorial Sloan-Kettering Cancer Center
New York, United States
The James Cancer Hospital and Solove Research Institute
Columbus, United States
Uni of Texas - Md Anderson Cancer Center
Houston, United States
Huntsman Cancer Institute at The University of Utah
Salt Lake City, United States
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Australia
Peter MacCallum Cancer Center
East Melbourne, Australia
Monash Medical Centre
Melbourne, 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, Italy
Osp. San Raffaele
Milan, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Sant'Andrea Delle Fratte (PG), 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
Trial contact
Reference Study ID Number: BO43243 https://forpatients.roche.com/ No attachments to email below.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.
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