Last updated on October 2017

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

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Anas Younes

Memorial Sloan Kettering Cancer Center Dept of IRB
New York, NY United States
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Michael Wang

MD Anderson Cancer Center-University of Texas
Houston, TX United States
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Prof. Dr. Richard Greil

Novartis Investigative Site
Salzburg, Austria
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Novartis Pharmaceuticals

Novartis Investigative Site
Pierre-Benite Cedex, France
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Novartis Pharmaceuticals

Novartis Investigative Site
Toulouse Cedex 9, France
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Novartis Pharmaceuticals

Novartis Investigative Site
Freiburg, Germany
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Novartis Pharmaceuticals

Novartis Investigative Site
Mainz, Germany
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