This trial will evaluate the effects of a new treatment parsaclisib (INCB050465) in relapsed or unresponsive follicular lymphoma (FL). Response rate, survival, and side effects will be the main outcomes measured.
The details
Many patients are cured with treatments for follicular lymphoma (FL). Some, however, lose response to therapy over time (relapse). Others do not respond to therapy at all (refractory). Parsaclisib is a new treatment which may be effective for these patients.
This trial is examining the safety and effectiveness of parsaclisib in patients with relapsed or unresponsive FL. Objective response rate will be the main outcome measured in this study. This is the percentage of patients who achieve a partial or complete response in the year after the study starts.
Who are they looking for?
This study will enroll 100 patients with relapsed or unresponsive FL. Patients who cannot receive stem cell transplant can participate. Participants must have previously been treated with at least two anti-lymphoma treatments. Participants must be willing to undergo tissue sample.
Patients who have previously had lymphoma in the brain or transformed lymphoma will not be included. Those who have been treated with drugs acting as parsaclisib (such as ibrutinib)will not be included. Patients who have undergone stem cell transplant in the 3-6 months before the start of the study will not be included.
How will it work
This study will include two treatment groups. Participants in group 1 will receive parsaclisib once a dayfor 8 weeks and then will receive parsaclisib once a week. Participants in group 2 will receive parsaclisib once a day. Treatment will continue for up to one year or until participants experience cancer worsening.
Objective response rate will be measured at weeks 8, 16, 24 and every 12 weeks up to the 96th week. After this, This will be measured every 24 weeks up to 12 months.
