Follicular Lymphoma, Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase Ib Dose Escalation Study of BCL201 in Combination With Idelalisib in Patients With Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)
This is a phase Ib multi-center, open-label study: escalation part followed by expansion
part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety
and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.
Approximately 65 patients are to be enrolled.
The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab
abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic
regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib.
In addition Bayesian regression models will be used to estimate the dose-exposure
relationships for both BCL201 and idelalisib in order to guide the escalation steps. A
Bayesian method for the expansion part will be used for the primary activity objective.
The study data will be analyzed and reported based on all patients' data of the escalation
and expansion part.
n/a