Actively Recruiting
Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
Led by Juan P. Alderuccio, MD · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Juan P. Alderuccio, MD
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Zanubrutinib combined with Pola-R-CHP and high-dose Methotrexate in patients who have Secondary Central Nervous System (CNS) Lymphoma, a cancer affecting the brain and related areas. This Phase 1 study aims to understand both the positive and negative impacts of this combination treatment on participants with this serious condition. Participants will receive Zanubrutinib orally starting at Cycle 2 of Pola-R-CHP therapy, either 160 mg twice daily or 320 mg once daily. The other drugs—Methotrexate, Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone—will be given as part of the standard Pola-R-CHP treatment. Participants will remain in the study group for up to two years while receiving these therapies. During the study, researchers will monitor participants for dose-limiting toxicities within the first 21 days and track several outcomes over up to five years, including response rates, survival, and any treatment-related side effects. Assessments will include scans to measure tumor response and regular safety checks. The study involves ongoing evaluations to understand how well participants tolerate the treatment and how their disease progresses over time.
CONDITIONS
Brief Title
Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older at the time of informed consent
- Histologic confirmation of large B-cell lymphoma (LBCL) of any subtype
- At least one measurable tumor site shown by PET/CT or CT scans
- Presence of both systemic lymphoma and CNS involvement at diagnosis
- CNS involvement confirmed by biopsy, cerebrospinal fluid evaluation, imaging, or strong clinical suspicion
- ECOG performance status of 0 to 2, except if due to lymphoma
- Life expectancy of at least 3 months
- Agreement to use effective contraception during and for 90 days after treatment if of childbearing potential
- Normal organ and marrow function as defined by specific blood count and liver/kidney function criteria
- Ability to provide informed consent and comply with study requirements
You will not qualify if you...
- Primary CNS lymphoma without systemic lymphoma
- Previous systemic lymphoma therapy except limited allowed treatments
- Uncontrolled or significant cardiovascular diseases including recent heart attack, unstable angina, severe heart failure, and serious arrhythmias
- Uncontrolled high blood pressure above specified limits
- Significant ECG abnormalities such as prolonged QT interval or advanced heart block
- Active autoimmune anemia or thrombocytopenia
- Serious uncontrolled illnesses or psychiatric conditions
- Severe lung disease
- Concurrent cancer requiring active treatment
- Recent prior malignancy within 3 years except certain treated cancers
- Active infections requiring systemic therapy
- Pregnant or breastfeeding women
- Known active HIV or hepatitis B or C infection unless well controlled
- Impaired decision-making ability
- Use of strong CYP3A inducers
- Medical conditions that increase risk or interfere with study treatment
- Inability to swallow capsules or serious gastrointestinal disorders
- History of severe bleeding disorders
- Recent stroke or brain bleeding within 180 days
- Major surgery within 4 weeks before starting study drug
- Need for anticoagulant therapy with warfarin or similar
- Recent live vaccination within 28 days before treatment
- Allergy to study drugs or their components
- Participation in another therapeutic clinical trial concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until start of Cycle 2
Participants begin Pola-R-CHP therapy as part of the standard of care.
Visits as per standard Pola-R-CHP therapy schedule
Duration - Up to 2 years
Participants receive Zanubrutinib starting at Cycle 2 combined with Pola-R-CHP and high-dose Methotrexate as per standard of care.
Visits according to treatment cycles and assessments during up to 2 years
Duration - Up to 5 years
Participants are monitored for treatment outcomes and adverse events after treatment completion.
Periodic visits for up to 5 years
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
J
Juan P Alderuccio, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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