NCT06390956 · University of Utah
Pirtobrutinib in Combination With Rituximab in Adults With Untreated Marginal Zone Lymphoma (PIONEER-MZL)
What this study 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.
View original scientific description
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.
Interventions
DRUG
Pirtobrutinib
Administered once daily as an oral medication.
DRUG
Rituximab
Rituximab is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration. The product is formulated for intravenous administration in 9.0 mg/mL sodium chloride, 7.35 mg/mL sodium citrate dihydrate, 0.7 mg/mL polysorbate 80, and Sterile Water for Injection.
Primary outcome measures
Objective response rate (ORR) defined as the proportion of subjects achieving a partial response (PR) or complete response (CR) by Lugano Criteria at Cycle 7.
Time frame: 7 months
To assess the ORR in the study population at Cycle 7.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects aged ≥ 18 years.
- ECOG Performance Status ≤ 2.
- Histologically confirmed marginal zone lymphoma, including splenic, nodal, and extranodal sub-types per the enrolling institution.
- Subjects must have an indication for treatment.
- No prior systemic therapy for MZL except for the following:
- Prior antibiotic therapy for H. pylori, C. psittaci, and B. burgdorferi
- Prior antiviral therapy for HCV ---Note: Subjects are eligible if they had a prior splenectomy or other local surgical treatment or local radiation therapy without systemic therapy and now require their first ever systemic therapy. In the event of the receipt of radiation therapy, the minimum washout period is 14 days
- Subjects with gastric MALT lymphoma must be H. pylori negative or have failed a trial of H. pylori eradication
- Subjects with localized MALT lymphoma must be ineligible for, have refused or failed radiation therapy (washout period of 14 days)
- Adequate organ functi
Where
- St Louis, Missouri
- Salt Lake City, Utah
Collaborators
Eli Lilly and Company
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2025 · Source of record for eligibility and locations