Actively Recruiting
Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
Led by M.D. Anderson Cancer Center · Updated on 2026-04-23
50
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.
CONDITIONS
Official Title
Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathology-confirmed mantle cell lymphoma with CD20 positivity
- Newly diagnosed mantle cell lymphoma with no prior therapy
- Low risk defined as Ki-67% 30% or less, no high-risk disease features, largest tumor size 3 cm or less
- Medium risk defined as Ki-67% 50% or less, largest tumor size 5 cm or less, no high-risk disease features
- Well-controlled cardiovascular conditions allowed with cardiology clearance and ejection fraction 50% or higher
- Signed informed consent
- At least one site of radiographically assessable disease or isolated gastrointestinal, bone marrow, or spleen involvement allowed
- ECOG performance status of 2 or less
- Prothrombin and partial thromboplastin times not exceeding 1.2 times institutional upper limit
- Adequate bone marrow function and organ function as defined by lab criteria
- Life expectancy over 12 weeks related to lymphoma
- Female participants must be surgically sterile, postmenopausal for at least 1 year, or have negative pregnancy test
- Willingness to use highly effective contraception during and after study treatment as specified
- Oocyte donation prohibited during participation and for 1 month after last dose of pirtobrutinib
You will not qualify if you...
- Central nervous system involvement with mantle cell lymphoma or suspected/confirmed progressive multifocal leukoencephalopathy (PML)
- High-risk mantle cell lymphoma with blastoid/pleomorphic histology, high Ki-67 over 50%, bulky disease, lymphocytosis 50,000 cells/uL or more, TP53 mutation or del17p, MYC rearrangement, complex karyotype, or high-risk biologic MIPI
- Major surgery within 4 weeks before registration
- History of bleeding disorders
- Known active cytomegalovirus infection
- Uncontrolled infections or clinically significant active disease posing risk
- Significant cardiovascular diseases including uncontrolled arrhythmias, heart failure, recent myocardial infarction, or severe cardiac disease
- Malabsorption syndrome or significant gastrointestinal diseases affecting oral medication absorption
- Pregnancy or plans to become pregnant during or shortly after study treatment
- Lactation during treatment or shortly after
- Current use of strong CYP3A4 or P-gp inhibitors or inducers including grapefruit products
- Use of warfarin or vitamin K antagonists
- Difficulty swallowing oral medication
- Recent stroke or intracranial hemorrhage
- Live vaccine within 28 days prior to enrollment
- Hypersensitivity to study drugs or excipients
- Prior major bleeding events or severe arrhythmias on BTK inhibitors
- Positive HIV test
- Active hepatitis B or C infection
- Prolonged QT interval on ECG
- Concomitant or recent malignancies except certain treated cancers
- Allergies to xanthine oxidase inhibitors or rasburicase
- Severe medical or psychiatric conditions increasing risk
- No concurrent anticancer therapies or recent major surgery
- Uncontrolled autoimmune cytopenias
- Chronic corticosteroids above allowed doses
- History of graft-versus-host disease or transplant
- Uncontrolled serious medical conditions such as hypertension, diabetes, coronary artery disease, COPD, renal failure, infections, hemorrhage, or psychiatric illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Ranjit Nair, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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