🏛️ Verified NIH Record • Updated 2025-11-26
Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma (PIONEER-MZL) (NCT06390956)
🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Utah
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this clinical trial is to learn if the drugs Pirtobrutinib and Rituximab are effective for the treatment of newly diagnosed marginal zone lymphoma.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (37 items) and avoid the listed exclusions (25 items).
Location: Washington University — St Louis, Missouri
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck 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:
- Subjects requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.
- Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.
- History of bleeding diathesis
- Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
- The diagnosis of another malignancy which is, in the opinion of the investigator, likely to negatively impact study participation or subject safety.
- Subjects with CNS involvement
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders:
- Grade 3 NYHA functional classification system of heart failure, uncontrolled or symptomatic arrhythmias ---Unstable angina pectoris or acute coronary syndrome within 2 months of first dose.
- History of myocardial infarction within 3 months prior to the first dose of study treatment
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Washington University — St Louis, Missouri
- Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah
💰 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.