Study on Polatuzumab Vedotin and Combination Chemotherapy for Treating Untreated Lymphoma

Sponsor: Barbara Ann Karmanos Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04479267

Provider View

This clinical trial is exploring how well a new treatment using polatuzumab vedotin combined with chemotherapy works for patients with certain types of lymphoma that have not been treated before. The study aims to see if this combination can better control the cancer compared to chemotherapy alone.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with specific types of lymphoma that have not been treated before. The treatment combines polatuzumab vedotin, a drug that targets cancer cells, with a mix of chemotherapy drugs. The goal is to see if this combination can help stop the cancer from growing or spreading more effectively than chemotherapy alone.

Description

The main goal of this study is to find out how many patients achieve complete remission, meaning no signs of cancer, after receiving polatuzumab vedotin with chemotherapy drugs rituximab, cyclophosphamide, doxorubicin, and prednisone. This will be measured using special imaging tests about 6-8 weeks after the last dose of treatment.

The study also aims to evaluate the safety of this treatment combination and how well patients tolerate it. Researchers will look at how long patients live without the cancer getting worse and their overall survival rates. They will also assess how long the response to treatment lasts and explore how certain proteins in the cancer cells might affect the treatment's effectiveness.

Patients in the study will receive the treatment every 21 days for up to 6 cycles, as long as the cancer does not progress and side effects are manageable. After completing the treatment, patients will have follow-up visits every 3 months for a year.

Eligibility Criteria

Inclusion Criteria

  • Must have signed a consent form agreeing to participate.
  • Have not received prior treatment for their lymphoma, except for one cycle of a specific chemotherapy regimen.
  • Diagnosed with certain types of lymphoma, such as double or triple hit lymphoma, or high-grade B-cell lymphoma.
  • Must provide a sample of their tumor tissue for analysis.
  • Be in good general health with a performance status score of 0, 1, or 2.
  • Have a life expectancy of at least 24 weeks.
  • Have at least one measurable tumor.
  • Have adequate heart function and blood counts.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Men must agree to use condoms and not donate sperm during and after the study.

Exclusion Criteria

  • Cannot have allergies to any of the study drugs or similar medications.
  • Cannot have received certain cancer treatments before starting the study.
  • Cannot have certain types of lymphoma or other cancers that could interfere with the study.
  • Cannot have uncontrolled health conditions that could affect the study results.
  • Cannot have active infections or a history of certain viral infections.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had recent major surgery or received a live vaccine recently.
  • Cannot have certain abnormal lab results unless related to their lymphoma.

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