This phase 2 trial is evaluating the effectiveness of acalabrutinib (Calquence) with or without obinutuzumab (Gazyva) 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 being conducted in Phoenix, Arizona, Jacksonville, Florida, and Rochester, Minnesota, United States.
Typical treatments for SLL include rituximab (Rituxan) combined with other drugs. Chemotherapy is also used. For patients with hard-to-treat disease, targeted therapy has become the preferred standard of care. This type of treatment targets certain proteins on cancer cells and blocks their growth. This leads to cancer cell death. Acalabrutinib and obinutuzumab are such targeted therapies.
This study is evaluating the effectiveness of acalabrutinib with or without obinutuzumab 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 trial is recruiting 120 patients with chronic lymphocytic leukemia (CLL) or SLL. Patients must be previously untreated. All patients must agree to use contraception and be willing to provide blood, bone marrow, and saliva samples.
Patients that have been diagnosed with more than 2 years before the trial cannot participate. Patients with uncontrolled infections or brain cancer cannot participate. Patients who are currently receiving antiretroviral therapy for the treatment of HIV cannot participate. Patients with other cancer for at least 2 years prior cannot participate. Patients who have received a live vaccine within the past month cannot participate.
How will it work
This trial will involve three groups of patients. The first group will receive acalabrutinib only. The second group will receive acalabrutinib and obinutuzumab. These groups will receive up to 12 cycles of treatment. The third group will receive observation only (no treatment). This group will be observed every 6 months. Patients will be followed-up for 2 years.
Effectiveness will be measured as the complete response rate at 2 years after treatment. In the third group of patients, the amount of time until the first therapy is given after the end of the study will also be measured. The number of patients who experience side effects for up to 5 years after treatment will also be measured.