This study is investigating the effectiveness of ibrutinib (Imbruvica) for patients with relapsed or refractory (not responding to treatment) classical Hodgkin’s lymphoma (HL). Effectiveness is measured by the overall response rate (percentage of patients whose cancer shrinks or completely disappears after treatment). This study is being conducted in Detroit, Michigan and Houston, Texas.
The details
Ibrutinib is a type of targeted therapy. This type of treatment blocks the growth of cancer cells but does not affect healthy cells. Since targeted therapy attacks only cancer cells without damaging healthy ones, there may be fewer side effects.
This study is investigating the effectiveness and safety of ibrutinib in patients with relapsed or refractory (did not respond to treatment) classical Hodgkin lymphoma. The overall response rate, duration of response (time from treatment response to disease progression), and progression-free survival (time from study treatment before disease progression or death) are used to determine effectiveness. Safety is evaluated from the number of patients experiencing side effects.
Who are they looking for?
This study is recruiting 35 patients. To participate in this study, patients must have received any stem cell therapy at least 3 months before the first study drug dose. Any radiation, chemotherapy, or biological therapy must be finished at least 4 weeks before the first study drug dose. CT scans are also required to confirm the cancer.
Patients who have HIV, hepatitis B, or hepatitis C cannot participate in this study. Patients who received previous donor stem cell transplants cannot participate. Patients taking targeted therapy drugs or immunosuppressants cannot take ibrutinib at the same time. Patients with a history of stroke within 6 months or a history of other cancer cannot participate. The only exception is for cancers cured at least 3 years before the first study drug dose. Patients who received live, weakened vaccines or had major surgery within 4 weeks before the first study drug dose cannot participate.
How will it work
Patients receive one dose of ibrutinib by mouth daily for 28 days. This course of treatment is repeated if patients do not show disease progression or intolerance to treatment. The study is estimated to take a total of 3 years. After finishing the study, patients are followed up at 30 days, and then every 9 weeks for up to 1 year.
