Actively Recruiting
Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-05
43
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas).
CONDITIONS
Official Title
Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated marginal zone lymphoma (MZL) or follicular lymphoma (FL) confirmed by pathology
- For MZL: nodal, splenic, or advanced extranodal disease needing systemic therapy
- For FL: grades 1, 2, or 3a as per WHO 2008 classification, excluding grade 3B
- Disease requires systemic therapy, not just local radiation
- Measurable disease with lymph node or tumor at least 1.5 cm by CT
- Confirmed CD20+ status
- Presence of symptoms, threatened organ function, or lymphoma-related cytopenia indicating treatment
- Age 18 years or older
- ECOG Performance Status of 0 to 2
- Ability to swallow whole pills
- Willingness to follow study requirements
- Female participants must be either non-reproductive or have negative pregnancy test
- Use of effective birth control methods during and after treatment as specified
- Adequate organ function
You will not qualify if you...
- Prior lymphoma treatment including chemotherapy or immunotherapy, except corticosteroids stopped 5 days before entry
- Previous use of BTK inhibitors
- Known significant allergy to rituximab
- History of other cancers unless disease-free for at least 2 years (with some exceptions)
- Evidence of large B cell transformation or aggressive lymphoma types
- Central nervous system involvement by lymphoma
- Known bleeding disorders
- Use of warfarin or Vitamin K antagonists
- Need for ongoing treatment with moderate or strong CYP3A inhibitors or inducers
- Active infections requiring recent IV antibiotics or hospitalization
- HIV infection
- Active hepatitis B or untreated hepatitis C
- Live vaccine within 28 days prior to treatment
- History of uncontrolled seizures
- Significant cardiovascular disease or recent heart events
- Uncontrolled high blood pressure
- Stroke or brain bleeding within last 6 months
- Recent major or minor surgery within specified time frames
- Any life-threatening or serious medical condition that may risk safety or study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
R
Richard Corona
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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