Actively Recruiting
Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma
Led by University College, London · Updated on 2025-04-16
50
Participants Needed
13
Research Sites
228 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase II, multicentre, randomised, open-label study to assess the benefit of early intervention with fixed duration, time-limited zanubrutinib-rituximab in indolent mantle cell lymphoma (MCL)
CONDITIONS
Official Title
Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or over
- Life expectancy of at least 6 months
- Pathologically confirmed mantle cell lymphoma with specific chromosome translocation and/or cyclin overexpression
- Stage II-IV mantle cell lymphoma measurable by CT imaging or blood/bone marrow infiltration
- Indolent mantle cell lymphoma defined by either: no treatment for at least 6 months after diagnosis, leukemic non-nodal variant without nodal involvement, or low tumor volume with specific features
- Eastern Cooperative Oncology Group (ECOG) Performance Status between 0 and 2
- Absolute neutrophil count of 1.0 x 10^9/L or higher and platelets of 75 x 10^9/L or higher, regardless of growth factor support
- Liver enzymes (AST and/or ALT) no more than 3 times the upper limit of normal
- Total bilirubin no more than 1.5 times the upper limit of normal unless due to Gilbert's syndrome or unrelated to mantle cell lymphoma
- Calculated creatinine clearance or glomerular filtration rate of at least 30 mL/min
- Ability to give voluntary written informed consent
- Willingness and ability to participate in all study evaluations and procedures, including swallowing capsules
- Negative pregnancy test for women of childbearing potential
- Willingness to comply with contraceptive requirements of the trial
You will not qualify if you...
- Any prior therapy for mantle cell lymphoma, including radiotherapy
- Central nervous system involvement of mantle cell lymphoma
- Uncontrolled infection with HIV or any active systemic infection; well-controlled HIV allowed
- Positive hepatitis B surface antigen or PCR test positive for hepatitis B; hepatitis C antibody and PCR positive
- No disease progression requiring treatment since diagnosis
- Vaccination with live vaccines within 4 weeks before randomization
- Major surgery within 28 days before randomization without full recovery
- Prior malignancies requiring active treatment except certain treated skin, cervical, prostate cancers or cancers disease-free for 2 or more years
- Requirement for moderate or strong CYP3A inducers; moderate and strong CYP3A inhibitors should be switched if possible
- Use of vitamin K antagonists such as warfarin
- Active bleeding disorders or history of severe bleeding requiring intervention
- Significant cardiovascular disease or recent cardiac events
- History of stroke or intracranial hemorrhage within 6 months
- Severe medical or psychiatric illness interfering with study participation
- Gastrointestinal conditions affecting capsule absorption or swallowing
- Pregnancy or breastfeeding
- Male participants with female partners of childbearing potential unwilling to use contraception
- Concurrent treatment with another investigational agent
- History of severe allergic reactions to monoclonal antibodies or murine products
- Known hypersensitivity to study drug components
- Severe or disabling lung disease
- Medical conditions making study drug use hazardous or confounding
- Participation in another therapeutic clinical trial
- Active autoimmune anemia or thrombocytopenia
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Royal Derby Hospital
Derby, United Kingdom
Actively Recruiting
2
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Actively Recruiting
3
Clatterbridge Cancer Centre
Liverpool, United Kingdom
Actively Recruiting
4
Guy's Hospital
London, United Kingdom
Actively Recruiting
5
St Bartholomew's Hospital
London, United Kingdom
Actively Recruiting
6
University College London Hospital
London, United Kingdom
Actively Recruiting
7
Christie Hospital
Manchester, United Kingdom
Actively Recruiting
8
Norfolk and Norwich University Hospitl
Norwich, United Kingdom
Actively Recruiting
9
Nottingham City Hospital
Nottingham, United Kingdom
Actively Recruiting
10
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
11
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
12
Southampton General Hospital
Southampton, United Kingdom
Actively Recruiting
13
Royal Cornwall Hospital
Truro, United Kingdom
Actively Recruiting
Research Team
Z
ZEBRA Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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