Last updated on August 2018

Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL


Brief description of study

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.

Clinical Study Identifier: NCT02603445

Contact Investigators or Research Sites near you

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Novartis Pharmaceuticals

MD Anderson Cancer Center-University of Texas
Houston, TX United States

Prof. Dr. Richard Greil

Novartis Investigative Site
Salzburg, Austria

Novartis Pharmaceuticals

Novartis Investigative Site
Pierre-Benite Cedex, France

Novartis Pharmaceuticals

Novartis Investigative Site
Toulouse Cedex 9, France

Novartis Pharmaceuticals

Novartis Investigative Site
Freiburg, Germany

Novartis Pharmaceuticals

Novartis Investigative Site
Mainz, Germany

Anas Younes

Memorial Sloan Kettering Dept of IRB
New York, NY United States