Title: Dose Optimization Study of Idelalisib in Follicular Lymphoma

Study Director: Study Director at Gilead Sciences

Description: Researchers are conducting a phase 3 study to establish a safe and effective dosing regimen of idelalisib for patients with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.


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Participants will receive idelalisib at 150 mg twice daily continuously, 100 mg twice daily continuously, or 150 mg twice daily in 28-day cycles with 21 days on treatment and 7 days off treatment.

The primary outcome measures are overall response rate and the incidence of grade 4 or higher treatment-emergent adverse events. Key secondary outcome measures include duration of response, overall response rate by week 24, progression-free survival, overall survival, and overall safety profile.

To be eligible for this study, patients must have a histologically confirmed diagnosis of grade 1, 2, or 3a B-cell FL. For a complete list of eligibility criteria, please refer to the reference.

Status: Recruiting

This study is sponsored by Gilead Sciences.

Reference

Clinicaltrials.gov. Dose optimization study of idelalisib in follicular lymphoma. NCT02536300. Accessed November 15, 2021.