Ibrutinib with Venetoclax for Mantle Cell Lymphoma

Phase 3 study of ibrutinib in combination with venetoclax in subjects with mantle cell lymphoma (MCL)

September 18, 2018

  • Clinical Trial Information

    Trial Contact: Walton, Sherri; Manchola-Orozco, Carolina

    Trial Phone: 321.841.1907 ; 321.841.7293

  • IRB No: 17.151.11

    Protocol Abbrev: PCYC-1143-CA

    Principal Investigator: Jose E. Sarriera, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: PCYC-1143-CA

    Treatment: Ibrutinib, Venetoclax

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT03112174

  • Objective

    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 Eligibility

    Subjects with mantle cell lymphoma confirmed and documented.
    Adequate hematologic function
    Adequate hepatic and renal function