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Home»Non-Hodgkin lymphoma» Looking for patients with untreated mantle cell lymphoma to test the effectiveness of a combination therapy including acalabrutinib
Clinical Trial
Looking for patients with untreated mantle cell lymphoma to test the effectiveness of a combination therapy including acalabrutinib
This phase 3 clinical trial will test the effectiveness of acalabrutinib (ACP-196) with rituximab (Rituxan) and bendamustine (Treanda) in treating patients with previously untreated mantle cell lymphoma. The primary outcome will be measured by the time until the disease progresses.
The details
Acalabrutinib is an investigational drug that may help stop the spread of mantle cell lymphoma by attaching to and blocking the function of a protein (BTK) that permits B-cell growth and development. These proteins are often overexpressed (overproduced) in mantle cell lymphoma, leading to uncontrolled B-cell growth. Rituximab is an approved immunotherapy drug 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. Bendamustine is a chemotherapy drug commonly used to treat lymphoma. Combining acalabrutinib with rituximab and bendamustinemay be more effective at treating mantle cell lymphoma compared to just rituximab and bendamustine.
The study will examine the time to disease progression and response rate up to 48 months.
Who are they looking for?
This trial is recruiting 546 patients 65 or older with mantle cell lymphoma who have not yet received treatment. Patients should not have any significant cardiovascular disease, uncontrolled infection or disease affecting gastrointestinal (GI) function.
How will it work
Patients will be randomly divided into 2 groups. One group will receive acalabrutinib, rituximab, and bendamustine, and the other group will receive a placebo (substance with no active effect) with rituximab and bendamustine.
Acalabrutinibor a placebo will be taken twice per day by mouth throughout the 28-day cycle. Bendamustinewill be given intravenously (through IV into a vein) on days 1 and 2, and rituximabwill be given intravenously on day 1 of the cycle.
Time to disease progression and response to the treatment will be measured.
