A Phase II Study of Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma
University of Utah
Summary
The purpose of this clinical trial is to learn if the drugs Pirtobrutinib and Rituximab are effective for the treatment of newly diagnosed marginal zone lymphoma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects aged ≥ 18 years. * ECOG Performance Status ≤ 2. * Histologically confirmed marginal zone lymphoma, including splenic, nodal, and extranodal sub-types per the enrolling institution. * Subjects must have an indication for treatment. * No prior systemic therapy for MZL except for the following: * Prior antibiotic therapy for H. pylori, C. psittaci, and B. burgdorferi * Prior antiviral therapy for HCV ---Note: Subjects are eligible if they had a prior splenectomy or other local surgical treatment or local radiation therapy without systemic therapy and now…
Interventions
- DrugPirtobrutinib
Administered once daily as an oral medication.
- DrugRituximab
Rituximab is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration. The product is formulated for intravenous administration in 9.0 mg/mL sodium chloride, 7.35 mg/mL sodium citrate dihydrate, 0.7 mg/mL polysorbate 80, and Sterile Water for Injection.
Locations (2)
- Washington UniversitySt Louis, Missouri
- Huntsman Cancer Institute at University of UtahSalt Lake City, Utah