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Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)

Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma

NCT03112174•Pharmacyclics LLC.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Relapsed/Refractory Arm
•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).
•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.
•Adequate hematologic, hepatic and renal function.
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of \<= 2.
•Pathologically confirmed treatment-naive MCL (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).
•Men and women ≥18 years of age with a TP53 mutation.
+4 more criteria

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.
•Anticancer therapy including chemotherapy, radiotherapy, small molecule and investigational agents \<= 21 days prior to receiving the first dose of study drug.
•Treatment with any of the following within 7 days prior to the first dose of study drug: moderate to strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers.
•Treatment Naïve Arm
•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.
+15 more criteria

Locations (120)

The University of Arizona Cancer Centre-North Campus

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

UCLA Department of Medicine-Hematology/Oncology

Los Angeles, California, United States

Orlando Health Inc.

Orlando, Florida, United States

The University of Kansas Cancer Center and Medical Pavilion

Westwood, Kansas, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Barbara Ann Karmanos Cancer institute

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Stony Brook University

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Key Dates

Start Date

June 19, 2017

Primary Completion Date

June 26, 2024

Completion Date

June 27, 2024

Last Updated

July 22, 2025

Enrollment

366

ACTUAL participants

Conditions

Mantle-Cell Lymphoma

Interventions

Ibrutinib

DRUG

Venetoclax

DRUG

Placebo Oral tablet to match Venetoclax

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)

Inclusion Criteria

Exclusion Criteria

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