Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)
Completed · Phase 3 · Has a placebo group
Conditions studied: Mantle-Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT03112174
- Run by
- Pharmacyclics LLC.
- People needed
- 366
- Starts
- 2017-06-19
- Expected to finish
- 2024-06-27
- Last updated by the study team
- 2025-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Inclusion Criteria:
- 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.
- At least 1 measurable site of disease by CT.
- Must have adequate fresh or paraffin-embedded tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to <= 2.
- Adequate hematologic, hepatic, and renal function.
- 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.
- Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
- Clinically significant infection requiring IV systemic treatment that was completed <=14 days before the first dose of study drug.
- Any uncontrolled active systemic infection.
- Known bleeding disorders (eg, von Willebrand's disease or hemophilia).
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- History of HIV or active HCV or HBV.
- Major surgery within 4 weeks of the first dose of study drug.
Where it is running
- 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
- Tennessee Oncology — Chattanooga, Tennessee, United States
- University of Tennessee medical Center — Knoxville, Tennessee, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Swedish Cancer Institute — Seattle, Washington, United States
- The Canberra Hospital — Canberra, Australian Capital Territory, Australia
- Border Medical Oncology Research Unit — Albury, New South Wales, Australia
- Icon Cancer Care — Auchenflower, Queensland, Australia
- Austin Health — Heidelberg, Victoria, Australia
- Peter MacCallum Cancer — Melbourne, Victoria, Australia
- St.Vincent's Hospital — Melbourne, Victoria, Australia
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
- ZiekenhuisNetwerk Antwerpen (ZNA) Stuivenberg — Antwerp, Belgium
- AZ Sint-Jan Brugge-Oostende AV — Bruges, Belgium
- Institut Jules Bordet — Brussels, Belgium
- CHU UCL Namur asbl- Mont Godinne — Yvoir, Belgium
- The University of Arizona Cancer Centre-North Campus — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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