This study is evaluating how well a new chemoimmunotherapy regimen works in treating patients with classical Hodgkin’s lymphoma (cHL) that has come back or stopped responding to treatment. The main outcome to be measured will be the number of patients who have a complete disappearance of all signs of cancer after treatment. This study is recruiting in Atlanta, GA.
Treatment remains challenging for patients with relapsed or unresponsive cHL. Combining chemotherapy with immunotherapy may be more effective than either treatment alone. Nivolumab (Opdivo) is a monoclonal antibody. This treatment helps the body’s immune system to attack the cancer. Gemcitabine (Gemzar) and bendamustine (Treanda) are chemotherapy drugs. These block cancer cell growth.
This study is evaluating how well these combined agents work in treating patients with cHL that has come back or stopped responding to treatment. The main outcome to be measured will be the number of patients who have a complete response (no signs of cancer) after treatment.
Who are they looking for?
This study is recruiting 54 patients with cHL that has come back or stopped responding to treatment. Patients should have had at least 1 prior anti-cancer therapy. However, patients who had an allogeneic stem cell transplant cannot participate.
All patients must agree to use contraception. Patients must have normal lung function and laboratory blood tests. Patients with active HIV or hepatitis B infections can participate if they pass specific blood tests. Patients with a thyroid condition or type 1 diabetes mellitus that is under control can participate.
Women who are pregnant or breastfeeding cannot participate. Patients with a history of cancer in the brain or spinal cord cannot participate. Patients with an autoimmune condition that requires therapy cannot participate.
How will it work
This study will have two phases. In the first phase, the optimal dose of treatment will be determined. In the second phase, this dose will be given to all patients. All patients will receive 6 courses of combined gemcitabine, bendamustine, and nivolumab.
Effectiveness will be measured as the number of patients who have no signs of cancer for up to 2 years after treatment. The number of patients who are still alive 2 years later without tumor growth or spread will also be measured. Patients will be followed-up every 3 months for 2 years.