A Phase III Study of Polatuzumab Vedotin Combined with Rituximab, Gemcitabine, and Oxaliplatin in People with Diffuse Large B-Cell Lymphoma

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Full Title

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination with Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Purpose

This study is being done to assess the safety of the drug polatuzumab vedotin given in combination with the drugs rituximab, gemcitabine, and oxaliplatin (Pola-R-GemOx) in people with diffuse large B-cell lymphoma that has continued to grow or came back despite other treatment.

Polatuzumab vedotin is a drug that targets a protein on B-cell lymphomas called CD79b. Polatuzumab vedotin binds to this protein, is absorbed by the cell, and then releases a potent toxin directly into the cell. It and the other chemotherapy drugs used in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have diffuse large B-cell lymphoma that has continued to grow or came back despite other treatment.
  • At least 2 weeks must pass between the completion of prior treatment and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Matasar at 212-639-8889.

Protocol

20-031

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Rodriguez-Rivera, Ildefonso, MD