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Home»Non-Hodgkin lymphoma» Looking for patients with relapsed indolent non-Hodgkin’s lymphoma to test the effectiveness of a PI3K inhibitor with immunochemotherapy
Clinical Trial
Looking for patients with relapsed indolent non-Hodgkin’s lymphoma to test the effectiveness of a PI3K inhibitor with immunochemotherapy
This phase 3 clinical trial will test the effectiveness of copanlisib (BAY 80-6946) with a standard immunochemotherapy (R-CHOP or R-B) compared to immunochemotherapy alone in patients with relapsed indolent non-Hodgkin’s lymphoma (iNHL). The primary outcome will be measured by the time to disease progression and the maximum tolerated dose.
The details
Copanlisib is an inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that helps carry out signals for growth and division in early B-cells. Blocking this protein may stop the growth of cancerous B-cells, eventually leading to cell death. R-CHOP and R-B are combination treatments containing rituximab (rituxan) and other chemotherapy agents. Rituximabis an immunotherapy 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 other parts of the immune system to attack.
This study will examine whether the combination of copanlisib and immunochemotherapy is effective in patients with relapsed iNHL.The study will examine the recommended dose after the first 28 days as well as the time to disease progression for 53 months. The trial will also consider the response rate and overall survival.
Who are they looking for?
This trial is recruiting 676 patients with relapsed iNHL. Participants must have received between 1 and 3 prior treatments. Participants with follicular lymphoma cannot have stage 3b or 4 disease. Patients should not have lymphoma involvement with the nervous system.
How will it work
Patients will be divided into two groups. One group will receive copanlisib with either R-CHOP or R-B immunochemotherapy. The other group will receive a placebo (substance with no active effect) and an immunochemotherapy. All of the drugs are administered intravenously (through IV into a vein).
Patients receiving the R-CHOP treatment will receive copanlisib (or a placebo) on days 1 and 8 and rituximab, along with the other chemotherapy drugs, on day 2 of a 28-day cycle. Patients receiving the R-B treatment will receive copanlisib (or a placebo) on days 1, 8, and 15 and rituximab on day 1 of each cycle. Chemotherapy will be delivered on days 1 and 2 of each cycle.
