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RecruitingNCT04231877

Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma

A Pilot Study to Estimate the Safety and Tolerability of the Combination of Polatuzumab Vedotin, With or Without Glofitamab, With Dose Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin (PERCH) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
56 (estimated)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.

Detailed description

OUTLINE: Patients are assigned to 1 of 2 arms. ARM A (CLOSED TO ACCRUAL 05/23/2024): Patients receive rituximab intravenously (IV) on day 1, polatuzumab vedotin IV on day 1, prednisone orally (PO) twice daily (BID) on days 1-5, etoposide IV on days 1-4, doxorubicin IV on days 1-4, and cyclophosphamide IV on day 5. Patients also receive filgrastim subcutaneously (SC) 24-72 hours after the last dose of each treatment cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo multigated acquisition (MUGA) scan or echocardiography during screening and fludeoxyglucose (FDG) positron emission tomography (PET), computed tomography (CT) scan, bone marrow biopsy and aspiration and blood sample collection throughout the study. ARM B: Patients receive rituximab IV on day 1, polatuzumab vedotin IV on day 1, prednisone PO BID on days 1-5, etoposide IV on days 1-4, doxorubicin IV on days 1-4, and cyclophosphamide IV on day 5. Starting with cycle 2, patients also receive glofitamab, over 4 hours, on day 1 and 8 of cycle 2 and day 1 of subsequent cycles. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and FDG PET, CT scan, bone marrow biopsy and aspiration and blood sample collection throughout the study. After the completion of study treatment, patients are followed periodically for up to 5 years.

Conditions

Interventions

TypeNameDescription
DRUGPolatuzumab VedotinGiven IV
BIOLOGICALRituximabGiven IV
DRUGPrednisoneGiven PO
DRUGEtoposideGiven IV
DRUGDoxorubicinGiven IV
DRUGCyclophosphamideGiven IV
BIOLOGICALGlofitamabGiven IV
PROCEDUREMultigated Acquisition ScanUndergo MUGA scan
PROCEDUREEchocardiography TestUndergo echocardiography
PROCEDUREFDG-Positron Emission TomographyUndergo FDG-PET scan
PROCEDUREComputed TomographyUndergo CT scan
PROCEDUREBone Marrow BiopsyUndergo bone marrow biopsy
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDUREBone Marrow AspirationUndergo bone marrow aspiration

Timeline

Start date
2020-10-27
Primary completion
2026-12-01
Completion
2031-12-01
First posted
2020-01-18
Last updated
2026-03-03

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04231877. Inclusion in this directory is not an endorsement.