🏛️ Verified NIH Record • Updated 2026-06-22

GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma (NCT06522386)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: M.D. Anderson Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

Primary Objectives: To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (28 items) and avoid the listed exclusions (28 items).

Location: Mayo Clinic in Rochester — Rochester, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • CNS involvement by MCL (e.g., any parenchymal, leptomeningeal, CSF, cranial nerve, or spinal cord or nerve root involvement).
  • Pregnant or plan to become pregnant during study treatment or within 1 month following the last dose of pirtobrutinib and/or venetoclax or within 12 months following the last dose of rituximab; or breast-feeding or plan to breastfeed during study treatment or within 1 week following the last dose of pirtobrutinib and/or venetoclax or within 6 months following the last dose of rituximab.
  • Malabsorption syndrome or other condition that precludes enteral route of administration.
  • Any of the following medication requirement or recent use:
  • Use of a strong or moderate cytochrome P450 (CYP) 3A inhibitor or inducer ≤ 7 days prior to registration
  • Anticipated requirement of a strong CYP3A inhibitor or inducer during the study that cannot be substituted
  • Use of grapefruit or grapefruit products, Seville oranges or products from Seville oranges, or star fruit ≤ 3 days prior to registration, or planned use during the study
  • Anticipated requirement of a strong P-gp inhibitor during the study
  • Anticoagulation with a vitamin K antagonist ≤ 7 days prior to registration or anticipated use during the study
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • History of a bleeding disorder (e.g., hemophilia, von Willebrand disease, etc.) or active bleeding.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Mayo Clinic in Rochester — Rochester, Minnesota
  • MD Anderson Cancer Center — Houston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗