Study on Polatuzumab Vedotin, Rituximab, and Chemotherapy for Treating Relapsed or Hard-to-Treat Diffuse Large B-Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT04665765

This clinical trial is testing a combination of drugs, including polatuzumab vedotin, rituximab, and chemotherapy, to see if they can help treat patients with diffuse large B-cell lymphoma that has returned or is not responding to treatment.

Patient Parameters

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Program Overview

This study is exploring whether a combination of drugs, including polatuzumab vedotin, rituximab, and chemotherapy drugs like ifosfamide, carboplatin, and etoposide, can effectively treat diffuse large B-cell lymphoma (DLBCL) that has come back or is not responding to treatment. Polatuzumab vedotin targets and kills specific cancer cells, while rituximab helps stop cancer cells from growing. The chemotherapy drugs work in different ways to stop cancer cells from growing and spreading. The study aims to find out if this combination can kill more cancer cells in patients with DLBCL.

Description

The main goals of this study are to see if the combination of polatuzumab vedotin, rituximab, and chemotherapy is safe and can effectively treat relapsed or hard-to-treat diffuse large B-cell lymphoma (DLBCL). The study will also look at how well patients respond to the treatment and how long they stay free of cancer after treatment.

Patients will receive the combination treatment in cycles, with each cycle lasting 21 days. If the cancer responds well, patients may receive additional cycles. After the initial treatment, patients may undergo a stem cell transplant and receive more polatuzumab vedotin to help keep the cancer from returning.

The study will also explore how the treatment affects cancer DNA in the blood and look for markers that might predict how well patients respond to the treatment. Patients will be monitored for side effects and overall health throughout the study and for up to two years after treatment.

Eligibility Criteria

Inclusion Criteria

Must provide consent to participate in the study.
Must be willing to provide a tissue sample from a previous biopsy.
Must have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL).
Must have relapsed or refractory DLBCL after previous treatment.
Must have measurable disease by CT or PET/CT scan.
Must be eligible for high-dose chemotherapy and stem cell transplant.
Must have adequate blood cell counts and organ function.
Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for a specified time after treatment.

Exclusion Criteria

Not eligible for stem cell transplant.
Have had a solid organ transplant.
Currently on high-dose steroids or other immunosuppressive therapy.
Have severe nerve damage or certain nerve diseases.
Have active central nervous system involvement by lymphoma.
Have an active infection requiring treatment.
Have another active cancer requiring treatment.
Have had a recent major surgery.
Have significant heart disease or recent heart attack.
Have active hepatitis B or C infection.
Have active HIV infection unless well-controlled.
Are pregnant or breastfeeding.
Have any condition that would make participation unsafe or difficult.

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Medical Center	91010	Duarte	California
Emory University	30322	Atlanta	Georgia

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