Los Angeles, California 90095

  • Cell Lymphoma

Purpose:

This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.


Criteria:

Relapsed/Refractory Arm Inclusion Criteria: - Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR) - At least 1 measurable site of disease on cross-sectional imaging (CT/PET) - At least 1, but no more than 5, prior treatment regimens for MCL - Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen - Subjects must have adequate fresh or paraffin embedded tissue Exclusion Criteria: - History or current evidence of central nervous system lymphoma - Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors - Prior treatment with venetoclax or other BCL2 inhibitors Treatment Naïve Arm Inclusion Criteria: - ≥65 years of age, or <65 years of age with a TP53 mutation - Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 - Adequate hematologic, hepatic, and renal function - Pathologically confirmed treatment-naïve MCL - At least 1 measurable site of disease Exclusion Criteria: - Blastoid variant of MCL - History or current evidence of CNS lymphoma - Concurrent enrollment in another therapeutic investigational study or prior therapy including ibrutinib or other BTK inhibitors - Prior treatment with venetoclax or other BCL2 inhibitors - History of stroke or intracranial hemorrhage within 6 months prior to enrollment - History of HIV or active HCV or HBV - Currently active, clinically significant cardiovascular disease; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization


NCT ID:

NCT03112174


Primary Contact:

Brandon Bishop
Phone: +1-855-427-8846
Email: medinfo@pcyc.com


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 26, 2021

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