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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follicular lymphoma (FL) | Experimental |
| |
| Mantle cell lymphoma (MCL) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCL201 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Characterized by Frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as electrocardiogram (ECG) changes | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of dose limiting toxicities (DLTs) | 24 months | |
| Exposure to BCL201 and idelalisib as measured by AUC0-24h at C1D15 | Cycle = 28 days | |
| Plasma concentration of BCL201, idelalisib and GS-563117 (metabolite of idelalisib) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | New York | New York | 10017 | United States | ||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000720460 | S55746 |
| C552946 | idelalisib |
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| Idelalisib |
| Drug |
|
|
| 24 Months |
| AUC pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117 | 24 months |
| Objective Response Rate (ORR) | 24 months |
| Best Overall Response (BOR) | 24 months |
| Duration of Response (DOR) | 24 months |
| Complete Response (CR) | 24 months |
| Partial Response (PR) | 24 months |
| Stable disease (SD) | 24 months |
| Cmax pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117 | 24 months |
| Houston |
| Texas |
| 77030 |
| United States |
| Novartis Investigative Site | Salzburg | 5020 | Austria |
| Novartis Investigative Site | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |