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BCL201

Phase 1

Follicular Lymphoma, Mantle Cell Lymphoma | Small molecule | Oncology |Novartis AG|Last Updated: Feb 24, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

BCL201 · 1 trial · 1 indication

Phase 1 1
NCT02603445Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCLFollicular Lymphoma, Mantle Cell Lymphoma
COMPLETED20 Analytics
PHASE1COMPLETED
Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL
Follicular Lymphoma, Mantle Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
24 months

Characterized by Frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as electrocardiogram (ECG) changes

Secondary Endpoints

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)
24 Months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Follicular lymphoma (FL)EXPERIMENTAL -
Mantle cell lymphoma (MCL)EXPERIMENTAL -

Interventions

NameTypeDescription
BCL201DRUG -
IdelalisibDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically confirmed diagnosis of FL or MCL according to WHO 2008 * Relapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens. * Either FDG-avid on FDG-PET or measurable disease by CT on cross sectional imagi...

Countries:United StatesAustriaFranceGermany
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Frequently asked questions about BCL201

What is BCL201 used for?

BCL201 is an investigational small molecule being studied for the treatment of Follicular Lymphoma and Mantle Cell Lymphoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BCL201?

BCL201 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.

What phase is BCL201 in?

BCL201 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies and is still being evaluated for safety and efficacy in clinical trials.

What clinical trials is BCL201 in?

BCL201 has been studied in one completed Phase 1 clinical trial, identified as NCT02603445. This trial evaluated the safety and efficacy of BCL201 in combination with idelalisib in patients with Follicular Lymphoma and Mantle Cell Lymphoma.

Is BCL201 the same as idelalisib?

No, BCL201 is not the same as idelalisib. BCL201 is a separate investigational drug being studied in combination with idelalisib in a clinical trial for Follicular Lymphoma and Mantle Cell Lymphoma.