Study on Mosunetuzumab and Polatuzumab Vedotin Compared to Rituximab with Gemcitabine and Oxaliplatin for Relapsed or Hard-to-Treat Aggressive B-Cell Non-Hodgkin's Lymphoma

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05171647

This clinical trial is testing a new combination of drugs, Mosunetuzumab and Polatuzumab Vedotin, to see if they are more effective and safer than the current treatment of Rituximab with Gemcitabine and Oxaliplatin for patients with aggressive B-Cell Non-Hodgkin's Lymphoma that has returned or is difficult to treat.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness and safety of a new drug combination, Mosunetuzumab and Polatuzumab Vedotin, with a standard treatment regimen of Rituximab, Gemcitabine, and Oxaliplatin in patients with aggressive B-Cell Non-Hodgkin's Lymphoma that has either returned after treatment or is not responding to current therapies.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Have a type of aggressive lymphoma that tests positive for CD20, including specific subtypes like Diffuse Large B-Cell Lymphoma or Transformed Follicular Lymphoma.
  • The cancer must have returned or not responded to at least one previous treatment.
  • If only one previous treatment was received, the patient must not be eligible for a stem cell transplant.
  • Must have measurable disease that can be tracked.
  • Must have adequate liver, blood, and kidney function.
  • Must have a creatinine clearance of at least 30 mL/min.
  • Must test negative for HIV, or if positive, must be stable on treatment with a CD4 count of at least 200 and an undetectable viral load.

Exclusion Criteria

  • Cannot be pregnant or breastfeeding, or planning to become pregnant during the study and for a specified time after the last dose of study drugs.
  • Cannot have difficulty following study requirements.
  • Cannot have had previous treatment with Mosunetuzumab, Polatuzumab Vedotin, or similar drugs.
  • Cannot have severe nerve damage or persistent side effects from previous cancer treatments.
  • Cannot have received certain cancer treatments within a specified time before starting the study.
  • Cannot have had a stem cell transplant or CAR T-cell therapy recently.
  • Cannot have had a solid organ transplant.
  • Cannot have a history of certain severe immune system reactions or other cancers that could interfere with the study.
  • Cannot have current or past central nervous system involvement with lymphoma or certain brain diseases.
  • Cannot have significant heart or lung disease.
  • Cannot have active infections or certain viral infections.
  • Cannot have had major surgery recently.
  • Cannot have received a live vaccine recently.
  • Cannot have tested positive for COVID-19 recently.
  • Cannot have a history of autoimmune disease or significant liver disease.
  • Cannot have participated in another clinical trial recently.

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