A Phase II Study of Atezolizumab Immunotherapy with or without Low-Dose Radiation Therapy for Patients with Recurrent or Persistent Advanced Follicular Lymphoma

Full Title

Two-Arm Parallel Phase 2 Clinical Trial of Atezolizumab with or without Low Dose Local Radiotherapy (2 x 2Gy) in Patients with Relapsed/Refractory Advanced Stage Follicular Lymphoma

Purpose

The purpose of this study is to assess the safety and effectiveness of atezolizumab immunotherapy with or without low-dose radiation therapy in patients with advanced follicular lymphoma that came back or continued to grow despite therapy. Atezolizumab is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. Atezolizumab is given intravenously (by vein) and is approved for treating advanced bladder cancer and lung cancer; its use in this study is considered investigational.

Radiation is a very effective therapy in patients with follicular lymphoma. Radiation therapy itself can enhance the immune system and boost the activity of another type of immunotherapy. Patients in this study will receive atezolizumab alone or with low-dose radiation to a single site (two doses of radiation given over two days).

Eligibility

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

  • Patients must have advanced follicular lymphoma that has come back or continued to grow despite at least one prior regimen of therapy.
  • At least 3 weeks must pass between the completion of prior anticancer treatment and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. M. Lia Palomba at 212-639-7186.

Protocol

17-360

Phase

II

Investigator

Co-Investigators