Study on Polatuzumab Vedotin and Chemotherapy With or Without Glofitamab for Untreated Aggressive Large B-cell Lymphoma

Sponsor: University of Washington

Sponsor score: 40

ClinicalTrials ID:NCT04231877

Provider View

This clinical trial is exploring the safety of using polatuzumab vedotin with chemotherapy, with or without glofitamab, to treat patients with aggressive large B-cell lymphoma that has not been treated before. The study aims to see if this combination can help control the cancer.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with aggressive large B-cell lymphoma, a type of cancer that grows and spreads quickly. The treatment involves using polatuzumab vedotin, a drug that targets cancer cells, along with standard chemotherapy drugs. Some patients will also receive glofitamab, another drug that may help stop cancer cells from growing. The goal is to see if these combinations are safe and effective in treating this type of lymphoma.

Description

The study is divided into two groups:

Group A (Closed to New Participants as of 05/23/2024):

  • Patients receive a combination of drugs including rituximab, polatuzumab vedotin, prednisone, etoposide, doxorubicin, and cyclophosphamide. These are given through an IV or taken orally over a 5-day period.
  • Filgrastim is given to help boost white blood cells after each treatment cycle.
  • Treatment cycles repeat every 21 days for up to 6 cycles unless the cancer progresses or side effects become too severe.
  • Patients undergo various scans and tests throughout the study to monitor their health and the cancer's response to treatment.

Group B:

  • Patients receive the same initial treatment as Group A.
  • Starting with the second cycle, patients also receive glofitamab on specific days.
  • Treatment cycles repeat every 21 days for up to 6 cycles unless the cancer progresses or side effects become too severe.
  • Similar to Group A, patients undergo regular scans and tests.

After completing the treatment, patients will be monitored periodically for up to 5 years to track their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have not received treatment for aggressive large B-cell lymphoma, a type of non-Hodgkin lymphoma.
  • Be planned to receive a full course of chemoimmunotherapy as standard care.
  • Be 18 years or older.
  • Have measurable cancer, with at least one tumor that can be seen on a scan.
  • Be in good overall health with a performance status score of 0 to 2.
  • Have adequate heart, blood, liver, and kidney function as determined by specific medical tests.
  • Women of childbearing potential must agree to use effective contraception during and after treatment.
  • Men must agree to use condoms or abstain from intercourse during and after treatment.
  • For Group B only: Must test negative for COVID-19 within 7 days before joining the study.

Exclusion Criteria

  • Have allergies or reactions to any of the study drugs.
  • Have received prior treatment for lymphoma, except for corticosteroids.
  • Have certain types of lymphoma or other cancers that could interfere with the study.
  • Have significant health issues, such as heart or lung disease, that could affect participation.
  • Have active infections that require treatment.
  • Be pregnant or breastfeeding, or planning to become pregnant during the study.
  • For Group B only: Have a history of certain autoimmune diseases or infections, or have active liver disease or tuberculosis.

Locations

FACILITYZIPCITYSTATE
Fred Hutch/University of Washington Cancer Consortium98109SeattleWashington

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