Rituximab and Zanubrutinib for Indolent B-cell Lymphomas
This study is testing a combination of two medications, zanubrutinib and rituximab, for people with previously untreated B-cell lymphomas. Specifically, it's for those with marginal zone lymphoma (MZL) or follicular lymphoma (FL). Zanubrutinib is an oral anti-cancer medicine, and rituximab is a biologic medicine given through an IV or injection. The main goal is to see how many patients respond to the treatment within six months. The study aims to enroll 43 participants, but its current recruitment status is unclear. To join, you must be at least 18 years old and have a confirmed diagnosis of MZL or FL.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 43 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured up to 6 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06350318
Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas
Recruiting
PHASE2Ages 18+InterventionalTreatmentH. Lee Moffitt Cancer Center and Research InstituteInvestigator-initiated
~43 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:ZanubrutinibRituximab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate: Cohort A
Measured over Up to 6 Months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Sameh Gaballa, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Cohort A: Previously untreated MZL. Prior therapy with H. Pylori antibiotic therapy or hepatitis C antiviral therapy are allowed on Cohort A.
Cohort B: Previously untreated FL
Pathological confirmation of lymphoma: availability of archival tissue confirming diagnosis of MZL (cohort A) or FL (cohort B). Availability of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens from within past 18 months from screening and pathological diagnosis confirmed by a pathologist at the participating site or willingness of the participant to undergo a fresh tumor biopsy if adequate archival tissue not available is required. This includes:
MZL (Cohort A):
FL (Cohort B):
All participants must have disease requiring systemic therapy rather than local radiation (ie, stage II only if not eligible for radiation therapy or with stage III/IV).
All participants should have measurable disease. Measurable disease is defined as a lymph node or tumor mass that is ≥ 1.5 cm in at least one dimension by CT or the CT portion of the PET/CT.
Documentation of CD20+ status.
All participants must have an indication for therapy such as: symptoms attributable to lymphoma, threatened end-organ function, or cytopenia secondary to lymphoma.
All participants must be 18 years of age or older.
All participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
All participants must be able to swallow whole pills.
All participants must have the ability and willingness to comply with the requirements of the study protocol.
All female participants who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
All female participants of childbearing potential must have a negative serum pregnancy test upon study entry.
All male and female participants of reproductive potential who agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices \[IUDs\], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy. Female participants of reproductive potential who are not surgically sterile must practice adequate birth control for a minimum of 30 days after last dose of zanubrutinib or 12 months after last dose of rituximab, whichever is longer. Male participants are eligible if abstinent, vasectomized, or if they agree to the use of barrier contraception in combination with other methods described above during the study treatment period and for ≥ 30 days after the last dose of zanubrutinib, or 12 months after the last dose of rituximab, whichever is longer.
All participants must have adequate organ function.
Exclusion
Prior therapy for lymphoma including chemotherapy or immunotherapy. Participant may have received corticosteroids but should be off them 5 days prior to study entry.
Prior exposure to a BTK inhibitor.
Known prior significant hypersensitivity to rituximab (not including infusion reactions).
Prior history of malignancies unless the patient has been disease free for ≥ 2 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of breast, localized prostate cancer, or superficial bladder cancer that has undergone curative therapy.
Participants with evidence of large B cell transformation or other aggressive histology (such as large cells seen on biopsy or high PET avidity in a single node seen on PET scan) are not eligible.
Known central nervous system (CNS) involvement by lymphoma.
Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).
Concomitant use of warfarin or other Vitamin K antagonists.
Requires ongoing treatment with a moderate or strongCYP3A inhibitor or inducer.
Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1.
Known infection with human immunodeficiency virus (HIV).
Viral Hepatitis:
Vaccination with a live vaccine ≤ 28 days prior to the start of treatment.
Participants should not have a history of uncontrolled seizures.
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment on the study.
Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg at screening.
Participants should not have a stroke or intracranial hemorrhage within last 6 months.
Participants may not have had major surgery within 28 days of enrollment, or minor surgery within 7 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
What this trial measures
- Overall Response Rate: Cohort AUp to 6 Months
Overall response rate will be determined using a 5 point scale per the Lugano criteria.
- Overall Response Rate: Cohort BUp to 6 Months
Overall response rate will be determined using a 5 point scale per the Lugano criteria.