At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Mosunetuzumab (drug), Tocilizumab (drug), Venetoclax (drug), Rituximab (drug)
- How long the study runs
- Study runs about 119 months (dates as stated)
- About the drug or intervention
- Mosunetuzumab — drug: Participants will receive subcutaneous (SC) mosunetuzumab. · Tocilizumab — drug: Participants will receive intravenous (IV) tocilizumab as needed for cytokine release syndrome (CRS) events. · Venetoclax — drug: Participants will receive daily oral venetoclax. · Rituximab — drug: Participants will receive IV rituximab as per protocol.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 332
- Started
- 2022-03-07
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for chronic lymphocytic leukemia or small lymphocytic lymphoma
- • Phase1 - 332 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma
Where?
- • Manchester - Christie Hospital NHS Trust
- • Oxford - Churchill Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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, compared to standard-of-care rituximab plus venetoclax.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Have a diagnosis of CLL requiring treatment according to the International Workshop on CLL (iwCLL) criteria (Hallek...
- ✓activity scale (ECOG) performance score (PS) of ≤ 2
- ✓healthy liver unless directly attributable to the participant's CLL
- ✓Life expectancy \> 6 months
- ✓For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to...
Who cannot take part
- ✗Participants who have received any of the following treatments prior to study entry: treatment with mosunetuzumab or...
- ✗Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL)
- ✗History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or...
- ✗safety concern to tocilizumab
- ✗History of prior cancer except for conditions defined by the protocol
See the full criteria
Where Is This Study? (2 UK sites)
Christie Hospital NHS Trust
Manchester M20 4BX, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Reference Study ID Number: BO43243 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
