NCT05169658

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

A Pilot Study of Subcutaneous Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for Untreated Indolent B-Cell Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests the effects of mosunetuzumab with or without polatuzumab vedotin and obinutuzumab for the treatment of patients with indolent B-cell non-Hodgkin lymphoma. Mosunetuzumab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79b receptors, and delivers vedotin to kill them. Giving mosunetuzumab with polatuzumab vedotin and obinutuzumab may work better in treating patients with untreated indolent B-cell non-Hodgkin lymphoma.

Detailed description

OUTLINE: PART A: Patients receive mosunetuzumab subcutaneously (SC) over 30 seconds-2 minutes on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo fludeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT), PET/CT and CT scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. PART B: Beginning cycle 9, patients who do not achieve a CR receive obinutuzumab intravenously (IV) on day 1, 8, and 15 of cycle 9 and day 1 of subsequent cycles and polatuzumab vedotin IV on day 1. Treatment repeats every 21 day for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, and FDG-PET scans, bone marrow biopsy, bone marrow aspirate, and collection of blood samples throughout the study. After completion of study treatment, patients are followed up for up to 5 years.

Conditions

• Non-Hodgkin Lymphoma
• Grade 1 Follicular Lymphoma
• Grade 2 Follicular Lymphoma
• Grade 3a Follicular Lymphoma
• Indolent B-Cell Non-Hodgkin Lymphoma
• Marginal Zone Lymphoma
• Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue

Interventions

Type	Name	Description
BIOLOGICAL	Mosunetuzumab	Given SC
BIOLOGICAL	Obinutuzumab	Given IV
DRUG	Polatuzumab Vedotin	Given IV
PROCEDURE	FDG-Positron Emission Tomography	Undergo FDG-PET and FDG-PET/CT
PROCEDURE	Computed Tomography	Undergo CT and FDG-PET/CT
PROCEDURE	Positron Emission Tomography	Undergo PET/CT and FDG-PET/CT
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2022-03-23
• Primary completion: 2025-04-02
• Completion: 2025-04-02
• First posted: 2021-12-27
• Last updated: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study