This study will evaluate the best dose of idelalisib (Zydelig) for patients with relapsed follicular lymphoma (FL). The primary outcomes are overall response and side effects.
FL is a slow-growing cancer of B-cells, a type of white blood cell. Idelalisib is a medication that inhibits certain proteins involved in the growth of B-cells. By blocking these proteins, idelalisib prevents FL from spreading. Idelalisib is already approved for the treatment of FL which has relapsed after previous treatment. However, it is not clear what is the best dose of idelalisib.
This study is comparing different doses of the drug in patients with FL who have no other treatment options. Outcomes include how many patients respond to treatment, how long before the cancer relapses, and side effects.
Who are they looking for?
This study is seeking 266 patients with B-cell FL who have relapsed or not responded following at least two previous treatments. Female patients must not be pregnant or nursing.
Patients must not have liver damage or hepatitis B or C, or HIV. Patients who have had a transplant from a donor, are taking immunosuppression medication are not eligible. Patients must not have previously been treated with a P3 kinase inhibitor, which is similar to idelalisib. Participants must not have inflammatory conditions or active infections.
How will it work
Patients will be randomly assigned to groups A, B, or C. Group A will receive 150 mg of idealisib tablets twice every day. Group B will receive 100 mg of idelalisib tablets twice every day. Group C will receive 150 mg of idelalisib tablets twice a day for 21 days, followed by 7 days without treatment.
Patients will be followed up for up to 10 years. The main outcomes evaluated will be a response to treatment and occurrence of side effects.