This phase 3 clinical trial will evaluate the safety and effectiveness of a copanlisib (BAY 80-6946)and rituximab (Rituxan)combination in treating patients with relapsed indolent B-cell non-Hodgkin’s lymphoma (iNHL). The primary outcome will be measured by time to disease progression.
Copanlisib is an inhibitor of phosphoinositide 3-kinase (PI3K), a protein that helps carry out signals for cell growth and division. Blocking this protein may stop the growth of cancerous B-cells, eventually leading to cell death. Rituximab is an immunotherapy, approved by the FDA, that uses the body’s own immune system to identify and kill cancerous B-cells. It is an antibody (a protein in the immune system) that binds to a protein found on B-cells, which alerts the immune system to attack.
This study will determine whether the combination of copanlisib and rituximab is effective in patients with relapsed disease. This study will examine the time to disease progression, disease response, overall survival, and adverse side effects over the course of 59 months.
Who are they looking for?
This trial is recruiting 514 patients with CD20 positive iNHL who have relapsed after at least 1 previous treatment. Patients who have previously received rituximabmust be treatment free for at least 1 year, or 6 months if considered unfit for chemotherapy. Patients should have adequate blood laboratory values.
Patients with lymphoma grade 3b or 4 are not eligible for treatment. Patients should not have HIV, or hepatitis B or C.
How will it work
Patients will be divided into two groups. One group will receive copanlisib and rituximab, while the other group will receive a placebo (substance with no active effect) and rituximab. Copanlisibor the placebo will be administered by injection on days 1, 8, and 15 of each 28-day cycle. Rituximabwill be delivered intravenously (through IV into a vein) on days 1, 8, 15, and 22 during the first cycle, then on days 1, 3, 5, 7, and 9 of the following cycles.