Study Comparing Glofitamab and Polatuzumab Vedotin with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Untreated Large B-Cell Lymphoma Patients

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06047080

This clinical trial is testing two treatment combinations to see which is more effective and safe for patients with large B-cell lymphoma who have not received any prior treatment.

Patient Parameters

Program Overview

The aim of this study is to compare the effectiveness and safety of two treatment combinations for patients with large B-cell lymphoma (LBCL) who have not been treated before. One group will receive a combination of glofitamab, polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone. The other group will receive polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone without glofitamab. The study will help determine which combination works better and is safer for patients.

Eligibility Criteria

Inclusion Criteria

  • Have not received any previous treatment for large B-cell lymphoma (LBCL) and have CD20-positive LBCL.
  • Able to provide a sample of tumor tissue.
  • Have an International Prognostic Index (IPI) score between 2 and 5.
  • Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Have at least one tumor that can be measured by a scan and is larger than 1.5 cm.
  • Have a heart function of 50% or higher as measured by specific heart tests.
  • Have adequate blood cell counts and organ function.
  • Test negative for HIV, with some exceptions.
  • Test negative for COVID-19.

Exclusion Criteria

  • Cannot have allergies or reactions to any of the study drugs or their components.
  • Cannot have had a solid organ transplant.
  • Cannot be taking certain immune-suppressing medications within four weeks before starting the study.
  • Cannot have severe nerve damage or certain nerve diseases.
  • Cannot have a history of slow-growing lymphomas or certain other types of lymphoma.
  • Cannot have lymphoma that has spread to the brain or spinal cord.
  • Cannot have received certain cancer treatments within the past three months.
  • Cannot have had radiation therapy to the chest area.
  • Cannot have had previous treatment for LBCL, except for steroids.
  • Cannot be taking high doses of steroids for reasons other than lymphoma.
  • Cannot have other cancers that might interfere with the study.
  • Cannot have significant heart disease.
  • Cannot have had major surgery recently.
  • Cannot have certain brain or nervous system diseases.
  • Cannot have certain viral infections or a history of certain immune system disorders.
  • Cannot have active autoimmune diseases that are not well controlled.
  • Cannot have significant liver disease.
  • Cannot have received a live vaccine recently or plan to during the study.
  • Cannot have an active infection or tuberculosis.
  • Cannot have chronic hepatitis B, hepatitis C, or HTLV-1 infections.
  • Cannot have a history of a specific brain infection.

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