Study on Pirtobrutinib and Rituximab for Newly Diagnosed Marginal Zone Lymphoma
Sponsor: University of Utah
ClinicalTrials ID:NCT06390956
This clinical trial is exploring whether the combination of Pirtobrutinib and Rituximab is effective in treating patients who have been newly diagnosed with marginal zone lymphoma, a type of cancer that affects the lymphatic system.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to determine if the drugs Pirtobrutinib and Rituximab can effectively treat patients who have recently been diagnosed with marginal zone lymphoma (MZL). MZL is a type of cancer that affects the lymph nodes and other parts of the lymphatic system. The study will evaluate the safety and effectiveness of this drug combination in patients who have not received prior systemic treatment for their MZL, except for certain specific therapies.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a performance status score of 2 or less, indicating full activity or some restriction in strenuous activities.
- Have a confirmed diagnosis of marginal zone lymphoma, including specific subtypes.
- Need treatment for their lymphoma.
- No previous systemic treatment for MZL, except for certain antibiotics or antiviral therapies.
- If previously treated with local surgery or radiation, must now require systemic therapy.
- For gastric MALT lymphoma, must be negative for H. pylori or have not responded to treatment for it.
- For localized MALT lymphoma, must be ineligible for, have refused, or not responded to radiation therapy.
- Have adequate organ function, including specific blood cell counts and liver and kidney function.
- Life expectancy of more than 3 months.
- Women must not be pregnant and must meet specific criteria for menopause or use effective contraception.
- Must be able to swallow tablets.
- Must be able to understand and consent to participate in the study.
Exclusion Criteria
- Need for blood thinners like warfarin.
- Recent live-virus vaccines or need for them during the study.
- Conditions affecting the absorption of the study drug.
- History of bleeding disorders.
- Recent major surgery or not fully recovered from it.
- Another cancer that could affect participation or safety.
- Cancer spread to the central nervous system.
- Uncontrolled or significant health issues, including certain heart conditions or recent heart attacks or strokes.
- Known HIV infection.
- Active hepatitis B or C infections.
- Active cytomegalovirus infection.
- Uncontrolled autoimmune blood disorders.
- Conditions affecting the ability to understand or consent to the study.
- Severe allergy to the study drugs or their components.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Huntsman Cancer Institute at University of Utah | 84112 | Salt Lake City | Utah |
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