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


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.

Study Start Date

May, 12 2017

Estimated Completion Date

September 2022


  • Drug: Venetoclax
  • Drug: Placebo Oral tablet to match Venetoclax
  • Drug: Ibrutinib

Study ID

Pharmacyclics LLC. -- PCYC-1143-CA



Trial ID


Study Type


Trial Phase

Phase 3

Enrollment Quota



Pharmacyclics LLC.

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




18 Years and older

Accepts Healthy Volunteers


Study Locations and Contact Information (7)

Study Location Distance Name Phone Email
Stony Brook University - New York, New York 22.8 miles None None None
John Theurer Cancer Center at Hackensack University Medical Center - Hackensack, New Jersey 47.6 miles None None None
Barbara Ann Karmanos Cancer institute - Detroit, Michigan 512.3 miles None None None
Tennessee Oncology - Chattanooga, Tennessee 781.8 miles None None None
Tennessee Oncology - Chattanooga, Tennessee 781.8 miles None None None
Tennessee Oncology - Chattanooga, Tennessee 781.8 miles None None None
City of Hope - Duarte, California 2,472.0 miles None None None provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.