A Phase III Study of Polatuzumab Vedotin with Standard Immunochemotherapy in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma

Full Title

GO39942: A Phase III, Multicenter, Randomized, Double- Blind, Placebo- Controlled Trial Comparing The Efficacy and Safety of Polatuzumab Vedotin in Combination with Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients with Diffuse Large B-cell Lymphoma

Purpose

The purpose of this study is to compare the safety and effectiveness of two drug combinations for patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL). The investigational treatment includes the drug polatuzumab vedotin, the standard drugs rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP), plus a placebo for vincristine. This treatment combination will be compared with the standard therapy: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), plus a placebo for polatuzumab. Patients will be randomly assigned to receive one treatment or the other.

Polatuzumab vedotin is an investigational 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 all the other chemotherapy drugs 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 DLBCL that has not yet been treated.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients ages 18 to 80.

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

Protocol

18-230

Phase

III

Investigator

Co-Investigators