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Home»Hodgkin's lymphoma» Looking for Hodgkin lymphoma patients to test the safety and effectiveness of the combined treatment with Ibrutinib and Nivolumab
Clinical Trial
Looking for Hodgkin lymphoma patients to test the safety and effectiveness of the combined treatment with Ibrutinib and Nivolumab
This phase 2 trial aims to test the safety and effectiveness of treatment with irutinib (Imbruvica) and nivolumab (Opdivo) in patients with recurrent (when the cancer comes back) Hodgkin lymphoma or that has not responded to the first line treatment. The main outcome to be measure will be the response of the cancer to treatment. This trial is recruiting in Ohio, United states.
The details
Ibrutinib stops tumor growth by blocking the growth of tumor cells. Nivolumab is a PD-1 agent that stimulates the immune system to attack and kill cancer cells. The combination of these two agents may increase the activity against cancer cells.
The current trial examines the combination treatment of nivolumab with ibrutinib in patients with recurrent Hodgkin lymphoma or that has not responded to the first line treatment. The main outcome to be measured is the immune-related response, the response of the tumor and the side effects related to the treatment.
Who are they looking for?
This trial will recruit 17 participants with recurrent Hodgkin lymphoma or that has not responded to the first line treatment. Patients must have a neutrophil count (type of white blood cell) of more than 1000/uL. Patients must have a platelet count of more than 75,000/uL. Other blood levels must be close to normal. Participants must not have been treated with ibrutinib before, must not have HIV, hepatitis, cardiovascular disease, brain metastasis (spread), or autoimmune diseases. Patients must not be under anticoagulation treatment, or history of stroke. Patients must not be pregnant.
How will it work
Participants will receive ibrutinib (orally) on days 1-21. Nivolumab will be delivered by IV (into a vein) over 60 minutes on day 1. Nivolumab will be delivered every 21 days for up to 16 courses. Treatment with ibrutinib continues until disease progression or toxicity.
The main outcome to be measured is the number of patients who acheive complete remission.
