Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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).
Eligibility criteria
Qualifiers
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
Nodal MZL requiring systemic therapy
Splenic MZL requiring systemic therapy
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Zanubrutinib
- Rituximab
Treatment groups
43 Participants
are divided into 2 treatment groupsSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov