A Phase III Study of Rituximab with and without Copanlisib in Patients with Recurrent B-Cell Non-Hodgkin Lymphoma

Full Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination with Rituximab in Patients with Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) -CHRONOS-3

Purpose

Rituxumab is a drug commonly used to treat non-Hodgkin lymphoma (NHL), but the cancer often comes back. In this study, researchers are evaluating the effectiveness of combining rituximab with the investigational drug copanlisib to see if it is more effective than rituximab alone for treating patients with B-cell NHL that has come back after prior treatment. Copanlisib works by targeting an enzyme called PI3K that drives cancer growth.

Patients in this study will be randomly assigned to receive rituximab with copanlisib or with a placebo (inactive drug). Two-thirds of the patients will be in the copanlisib group and one-third in the placebo group. Both rituximab and copanlisib 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 B-cell NHL that has come back after prior treatment.
  • Patients should recover from the serious side effects of previous therapies before entering 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 and to inquire about eligibility for this study, please contact Dr. John Gerecitano at 212-639-3748.

Protocol

15-236

Phase

III

Investigator

Co-Investigators