Actively Recruiting
Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma (PIONEER-MZL)
Led by University of Utah · Updated on 2025-12-04
23
Participants Needed
2
Research Sites
405 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma (PIONEER-MZL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG Performance Status of 2 or less
- Histologically confirmed marginal zone lymphoma (splenic, nodal, or extranodal subtypes)
- Indication for treatment of lymphoma
- No prior systemic therapy for MZL except prior antibiotics for certain infections or antiviral therapy for HCV
- Prior splenectomy, local surgery, or radiation allowed with minimum 14-day washout before systemic therapy
- Gastric MALT lymphoma patients must be H. pylori negative or failed eradication therapy
- Localized MALT lymphoma patients must be ineligible for, have refused, or failed radiation therapy with 14-day washout
- Adequate organ function including specific blood counts and liver and kidney function thresholds
- Life expectancy greater than 3 months
- For females, negative pregnancy test or post-menopausal status defined by specific criteria
- Agreement to use effective contraception if of childbearing potential
- No plans to become pregnant or breastfeed within specified time after treatment
- Ability to swallow oral tablets
- Ability to read, understand, and provide informed consent
You will not qualify if you...
- Requirement for therapeutic anticoagulation with warfarin or vitamin K antagonists
- Receipt of live-virus vaccines within 28 days before starting treatment or need for live-virus vaccines during treatment
- Active malabsorption syndrome or conditions affecting drug absorption
- History of bleeding disorders
- Major surgery within 4 weeks before treatment or incomplete recovery from major surgery
- Diagnosis of another malignancy affecting safety or participation
- Central nervous system involvement
- Uncontrolled significant illnesses including severe heart failure, symptomatic arrhythmias, recent heart attack or stroke, prolonged QTc interval, or low heart ejection fraction
- Known HIV infection
- Active hepatitis B or hepatitis C infection
- Known active cytomegalovirus infection
- Active uncontrolled autoimmune blood disorders requiring recent or escalated therapy
- Medical, psychiatric, cognitive, or other conditions affecting ability to consent or comply
- Severe hypersensitivity to study drugs or their components
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
2
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
CONTACT
N
Narendranath Epperla, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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