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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Zanubrutinib
DrugZanubrutinib is an anti-cancer medication administered orally.
Rituximab
DrugRituximab is a biologic medication administered intravenously or subcutaneously.
Treatment groups
43 Participants
are divided into 2 treatment groupsGroup A: Cohort A: Untreated Marginal Zone LymphomaExperimental treatment 2 interventions
Group B: Cohort B: Untreated Follicular LymphomaExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall Response Rate: Cohort A
Overall response rate will be determined using a 5 point scale per the Lugano criteria.
Time frame
Up to 6 Months2
Overall Response Rate: Cohort B
Overall response rate will be determined using a 5 point scale per the Lugano criteria.
Time frame
Up to 6 MonthsSecondary outcomes
1
Efficacy of Zanubrutinib and Rituximab
Time to event endpoints (Progression free survival, Overall survival, duration of response, time to next anti-lymphoma therapy) will be summarized by Kaplan-Meier method for each cohort.
Time frame
Up to 24 months2
Safety and tolerability of combination Zanubrutinib and Rituximab
Safety and tolerability of the combination use of zanubrutinib and rituximab will be summarized descriptively by frequencies and percentages. Statistics will be given on type, severity, frequency, and attribution of adverse events.
Time frame
Up to 24 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov