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Monoclonal Antibodies

Cohort B: Untreated Follicular Lymphoma for B-Cell Lymphoma

Phase 2
Recruiting
Led By Sameh Gaballa, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial aims to determine if combining zanubrutinib with rituximab is safe and effective for individuals with certain types of untreated B-cell lymphomas.

Who is the study for?
This trial is for individuals with untreated indolent B-cell lymphomas, specifically marginal zone and follicular lymphomas. Participants should meet certain health standards but specific inclusion and exclusion criteria are not provided.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of combining two drugs: Zanubrutinib, a cancer medication, and Rituximab, an antibody therapy. The goal is to see how well they work together in treating these types of lymphoma.See study design
What are the potential side effects?
Possible side effects from Zanubrutinib include bleeding problems, infections, fatigue, muscle pain; while Rituximab may cause infusion reactions, infections, body aches. Side effects can vary based on individual patient conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate: Cohort A
Overall Response Rate: Cohort B
Secondary outcome measures
Efficacy of Zanubrutinib and Rituximab
Safety and tolerability of combination Zanubrutinib and Rituximab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Untreated Follicular LymphomaExperimental Treatment2 Interventions
Rituximab (Standard of Care) will be administered for up to 6 cycles (28-day cycles). Cycle 1: Days 1, 8, 15, and 22. Cycle 2-6: Day 1, every 28 days. Rituximab: Intravenous rituximab formulations (IV rituximab or IV rituximab biosimilars will be administered by IV infusion at a dose of 375 mg/m2 per local institutional guidelines) or subcutaneous rituximab formulations (RITUXAN HYCELA) 1,400 mg/23,400 Units (1,400 mg rituximab and 23,400 Units hyaluronidase human) subcutaneously at a fixed dose per local institutional guidelines. Zanubrutinib 320 mg will be administered orally once daily starting on day 1 of cycle 1. Zanubrutinib will be continued once daily for up to 24 cycles or until disease progression or unacceptable toxicity occurs.
Group II: Cohort A: Untreated Marginal Zone LymphomaExperimental Treatment2 Interventions
Rituximab (Standard of Care) will be administered for up to 6 cycles (28-day cycles). Cycle 1: Days 1, 8, 15, and 22. Cycle 2-6: Day 1, every 28 days. Rituximab: Intravenous rituximab formulations (IV rituximab or IV rituximab biosimilars will be administered by IV infusion at a dose of 375 mg/m2 per local institutional guidelines) or subcutaneous rituximab formulations (RITUXAN HYCELA) 1,400 mg/23,400 Units (1,400 mg rituximab and 23,400 Units hyaluronidase human) subcutaneously at a fixed dose per local institutional guidelines. Zanubrutinib 320 mg will be administered orally once daily starting on day 1 of cycle 1. Zanubrutinib will be continued once daily for up to 24 cycles or until disease progression or unacceptable toxicity occurs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Zanubrutinib
2017
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

BeiGene, Ltd.UNKNOWN
2 Previous Clinical Trials
801 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,439 Total Patients Enrolled
Sameh Gaballa, MDPrincipal InvestigatorMoffitt Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"Indeed, information from clinicaltrials.gov confirms that this investigation is actively seeking volunteers. The trial was originally listed on March 13th, 2024 and most recently revised on April 1st, 2024. A total of 43 participants are sought at one designated site."

Answered by AI

What is the upper limit of participant enrollment for this medical study?

"Indeed, the details accessible on clinicaltrials.gov highlight that this medical trial is actively enrolling volunteers. The inception of the study dates back to March 13th, 2024, with the latest update recorded on April 1st of the same year. This research project aims to recruit a total of 43 participants from a single designated site."

Answered by AI

What are the safety considerations of Cohort A: Untreated Marginal Zone Lymphoma for individuals?

"The safety rating for Cohort A, focusing on Untreated Marginal Zone Lymphoma, is appraised at 2 by our experts at Power. This designation stems from the trial being in Phase 2, indicating existing data regarding safety but lacking evidence of efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas
2024. "Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06350318.
All > Marginal Zone Lymphoma > Tampa
~29 spots leftby Mar 2029
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