Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-05-04
137
Participants Needed
31
Research Sites
416 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of chronic lymphocytic leukemia (CLL) requiring treatment per iwCLL criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less
- Adequate bone marrow function within 2 weeks of screening unless low counts are due to CLL involvement
- Adequate liver function unless due to CLL
- Life expectancy greater than 6 months
- Women of childbearing potential must agree to abstain or use effective contraception and avoid egg donation during and for 3 months after treatment
- Men must agree to abstain or use a condom and avoid sperm donation as defined by the protocol
- For Arm B: Taking a BTKi for at least 12 months with progressive disease requiring salvage therapy, able to continue BTKi during screening and first two mosunetuzumab cycles
- For Arm C: Non-US participants only
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during study or within 3 months after final mosunetuzumab/tocilizumab dose or 30 days after venetoclax
- Prior treatment with mosunetuzumab, other CD20/CD3 bispecific antibodies, or allogenic stem cell transplant
- Recent radiotherapy within 2 weeks, autologous stem cell transplant within 100 days, CAR T-cell therapy within 30 days, or other specified treatments within set time frames before study treatment
- Received live attenuated vaccine within 4 weeks before study treatment or expected during study or within 5 months after treatment
- Transformation of CLL to aggressive non-Hodgkin's lymphoma
- History of severe allergic reactions to monoclonal antibody therapies
- Contraindication to tocilizumab
- History of prior malignancy except as defined
- Active infections requiring IV antibiotics or hospitalization within 4 weeks or known active infection at enrollment
- Significant concomitant diseases affecting protocol compliance or results
- Major surgery within 4 weeks prior to treatment except protocol-mandated procedures
- Positive SARS-CoV-2 test within 7 days prior to enrollment
- For Arm C: Prior venetoclax within 12 months, HIV or HTLV1 infection, uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- Use of strong/moderate CYP3A inhibitors or inducers, certain steroid therapies within 7 days prior to treatment
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before and during venetoclax administration
- Inability to swallow many tablets or conditions preventing oral drug intake
- Known allergy to xanthine oxidase inhibitors and rasburicase
AI-Screening
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Trial Site Locations
Total: 31 locations
1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55902
Actively Recruiting
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Withdrawn
3
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
4
Uni of Texas - Md Anderson Cancer Center
Houston, Texas, United States, 77030
Withdrawn
5
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
6
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
7
Peter MacCallum Cancer Center
East Melbourne, Victoria, Australia, 3002
Completed
8
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Actively Recruiting
9
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
10
Southern Medical University Nanfang Hospital
Guangzhou, China, 510515
Actively Recruiting
11
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
12
Tianjin Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 301600
Actively Recruiting
13
Chu de Clermont Ferrand
Clermont-Ferrand, France, 63003
Withdrawn
14
IUCT Oncopole
Toulouse, France, 31059
Withdrawn
15
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
16
Uniklinik Koln
Cologne, Germany, 50937
Withdrawn
17
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
18
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, Italy, 25123
Actively Recruiting
19
Osp. San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
20
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy, 20162
Actively Recruiting
21
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Sant'Andrea Delle Fratte (PG), Umbria, Italy, 06132
Actively Recruiting
22
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland, 80-214
Actively Recruiting
23
PRATIA MCM Kraków
Krakow, Poland, 30-727
Actively Recruiting
24
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, Poland, 50-367
Actively Recruiting
25
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
26
Seoul St Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
27
Yeouido St. Mary's Hospital
Seoul, South Korea, 07345
Actively Recruiting
28
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
29
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
30
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
31
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
R
Reference Study ID Number: BO43243 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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