This phase 2 study is evaluating the effectiveness of a new combination therapy for small lymphocytic lymphoma (SLL). The main outcome to be measured will be the number of patients who have a complete disappearance of all signs of cancer. This study is recruiting in Rochester, New York, US.
Typical treatments for SLL include rituximab (Rituxan) combined with other drugs. Although therapy options have increased, many patients eventually relapse. New treatments are needed for these patients. Targeted therapy is another treatment option. This type of treatment targets cancer cells and blocks their growth. This leads to cancer cell death.
This study is evaluating the effectiveness of acalabrutinib (Calquence) with rituximab for SLL. The main outcome to be measured will be the number of patients who have a complete response (complete disappearance of all signs of cancer).
Who are they looking for?
This study is recruiting 40 patients with SLL or chronic lymphocytic leukemia. Patients must not have received treatment before and must agree to use contraception during and after treatment. Participants must have adequate bone marrow, liver, and kidney function.
Patients currently receiving anti-cancer therapy cannot participate in this study. Patients with active infections, hepatitis B, hepatitis C, or HIV cannot participate. Patients with a history of heart failure, heart attack, or heart disease that is not under control by medications cannot participate. Patients taking blood thinners or proton pump inhibitors cannot participate.
How will it work
All patients will receive acalabrutinib and rituximab. After 12 cycles of treatment, a biopsy will be given to determine if patients have achieved a complete response. Patients who have responded fully to treatment will stop therapy and be followed-up. Patients who have not responded fully to treatment will continue acalabrutinib treatment.
The main outcome to be measured will be the number of patients who have a complete response at 1 year of therapy. Patients will be followed-up for 1 year.