RecruitingPhase 1NCT04231877

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


Sponsor

University of Washington

Enrollment

56 participants

Start Date

Oct 27, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called polatuzumab vedotin to a standard chemotherapy regimen (DA-EPOCH-R) can improve outcomes for patients with aggressive large B-cell lymphoma (a fast-growing type of blood cancer) that has certain high-risk features. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with an aggressive large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or related types) - You have not received any prior treatment for this lymphoma - Your doctor believes DA-EPOCH-R is the right standard treatment for you - Your cancer is measurable on imaging **You may NOT be eligible if...** - You have previously received treatment for this lymphoma - You have serious organ problems (heart, liver, kidneys) that would make chemotherapy unsafe - You have an active infection, including active HIV or hepatitis - You are pregnant or breastfeeding - You are unwilling or unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPolatuzumab Vedotin

Given IV

BIOLOGICALRituximab

Given IV

DRUGPrednisone

Given PO

DRUGEtoposide

Given IV

DRUGDoxorubicin

Given IV

DRUGCyclophosphamide

Given IV

BIOLOGICALGlofitamab

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA scan

PROCEDUREEchocardiography Test

Undergo echocardiography

PROCEDUREFDG-Positron Emission Tomography

Undergo FDG-PET scan

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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Visit

NCT04231877


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