Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05169658
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2021-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
A Pilot Study of Subcutaneous Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for Untreated Indolent B-Cell Non-Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: