A Phase II Study of Standard Therapies with or without Polatuzumab Vedotin in Patients with Recurrent or Persistent B-Cell Lymphomas

Full Title

A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination with Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-cell Lymphoma (Protocol version 14-SEP-2015)

Purpose

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. In this study, researchers are assessing the safety and effectiveness of standard therapies for B-cell lymphomas with and without polatuzumab in patients with follicular lymphoma or diffuse large B-cell lymphoma (DLBCL) whose cancers came back or continued to grow despite prior therapies.

Patients in the randomized portion of this study will be randomly assigned to receive bendamustine and rituximab either with or without polatuzumab vedotin. Patients in the “expansion” phase of the study will receive polatuzumab vedotin plus bendamustine and obinutuzumab. All of these treatments 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 follicular lymphoma or DLBCL that has come back or continued to grow despite at least one prior regimen of therapy.
  • At least 2 weeks must pass between completion of previous treatments 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 people 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

15-170

Phase

I

Investigator

Co-Investigators