A Phase III Study of Standard Immunochemotherapy with and without Copanlisib in Patients with Recurrent Non-Hodgkin Lymphoma

Full Title

A Phase III, Randomized, Double-Blind, Controlled, Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination with Standard Immunochemotherapy versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-4

Purpose

The purpose of this study is to compare treatment with copanlisib plus standard immunochemotherapy with immunochemotherapy alone in patients with slow-growing non-Hodgkin lymphoma (NHL) that has come back despite prior therapy. Standard immunochemotherapy includes the drug rituximab with either bendamustine or CHOP therapy (cyclophosphamide, doxorubicin, vincristine, and prednisone).

Copanlisib is an investigational anticancer drug. It is designed to inhibit cancer growth by blocking the activity of an enzyme cancer cells need called PI3 kinase. There will be a safety "lead-in" phase where all patients will receive copanlisib with immunochemotherapy. After that, patients will be randomly assigned to receive standard immunochemotherapy with copanlisib or with a placebo. All of the medications 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 indolent (slow-growing) CD20-positive NHL that has come back despite prior treatment that included rituximab.
  • 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 and to inquire about eligibility for this study, please contact Dr. John Gerecitano at 212-639-3748.

Protocol

16-873

Phase

III

Investigator

Co-Investigators