A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma
M.D. Anderson Cancer Center
Summary
To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.
Description
Primary Objectives: To determine the safety and efficacy of mosunetuzumab in combination with zanubrutinib as determined by best complete response (CR) rate of combination treatment for patients with relapsed or refractory marginal zone lymphoma (MZL). Secondary Objectives: To determine best overall response rate (ORR), duration of response (DOR), time to next treatment, progression-free survival (PFS), overall survival (OS), and evaluation of tolerability of mosunetuzumab and zanubrutinib as treatment for patients with relapsed/refractory MZL. Exploratory Objective: To determine the impa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Patients must meet the following criteria for study entry: 1. Histologically diagnosed marginal zone lymphoma (any subtypes) o Low grade or indolent B-cell lymphoma unclassifiable is also eligible 2. Have received at least 1 prior treatment including CD20 monoclonal antibody 3. Patients have relapsed or refractory disease to their most recent regimen 4. Stage II, III or IV disease 5. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of mosunetuzumab and zanubrutinib combination in patients \<18 years of age, children are exclude…
Interventions
- DrugMosunetuzumab
Given by IV
- DrugZanubrutinib
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas