Study Comparing Polatuzumab Vedotin with R-CHP and R-CHOP in Patients with Diffuse Large B-Cell Lymphoma

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03274492

Provider View

This clinical trial is comparing two treatment combinations for patients with Diffuse Large B-Cell Lymphoma (DLBCL) who have not received treatment before. The study aims to evaluate the effectiveness and safety of adding Polatuzumab Vedotin to the standard R-CHP treatment compared to the traditional R-CHOP regimen.

Patient Parameters

Program Overview

This study is designed to compare the effectiveness and safety of two different treatment combinations for patients with Diffuse Large B-Cell Lymphoma (DLBCL) who have not been treated before. One group will receive Polatuzumab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP), while the other group will receive Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP). The study will help determine which combination works better and is safer for patients.

Eligibility Criteria

Inclusion Criteria

  • Patients who have not been treated before and have a specific type of lymphoma called CD20-positive DLBCL.
  • Must have a tumor sample available for testing.
  • Have a certain score on the International Prognostic Index (IPI) between 2 and 5.
  • Be in good general health with a performance status score of 0, 1, or 2.
  • Have a life expectancy of at least 12 months.
  • Have a heart function of 50% or higher.
  • Have adequate blood cell counts and organ function.
  • Women must agree to use birth control or abstain from sex and not donate eggs.
  • Men must agree to use condoms or abstain from sex and not donate sperm.

Exclusion Criteria

  • History of severe allergic reactions to certain antibodies or sensitivity to mouse products.
  • Cannot take any of the drugs in the CHOP regimen or have had certain treatments before.
  • Have certain types of lymphoma or other cancers that could interfere with the study.
  • Have untreated or active infections, including hepatitis or HIV.
  • Have significant heart, liver, or lung diseases.
  • Have had major surgery recently or have certain heart conditions.
  • Have received live vaccines or investigational therapies recently.
  • Have a history of other serious health conditions that could affect the study.

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