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

Description

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

Interventions

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

Study ID

Pharmacyclics LLC. -- PCYC-1143-CA

Status

Recruiting

Trial ID

NCT03112174

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

287

Sponsor

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

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

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