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
262 weeks
Total Duration
On this page
Sponsors
J
Juan P. Alderuccio, MD
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to is to determine the effects (good and bad) of Zanubrutinib in Combination with Pola-R-CHP and High-dose Methotrexate in patients with Secondary Central Nervous System (CNS) Lymphoma.
CONDITIONS
Official 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 consent
- Histologic confirmation of large B-cell lymphoma of any subtype
- At least one measurable tumor site on PET/CT or CT scans
- Evidence of both systemic and CNS lymphoma involvement
- CNS involvement confirmed by biopsy, cerebrospinal fluid analysis, neuroimaging, or strong clinical suspicion
- ECOG performance status of 0 to 2 except due to lymphoma
- Life expectancy greater than 3 months
- Women of childbearing potential must use effective contraception during and for 90 days after treatment
- Male patients with female partners of childbearing potential must use barrier contraception or be vasectomized
- Normal organ and marrow function as defined by specific blood counts and lab values
- Ability to provide informed consent and comply with study requirements
You will not qualify if you...
- Primary CNS lymphoma without systemic lymphoma
- Prior systemic lymphoma therapy with anthracycline-based regimens beyond allowed exceptions
- Uncontrolled or significant cardiovascular disease including recent myocardial infarction, unstable angina, severe heart failure, or significant arrhythmias
- Uncontrolled high blood pressure
- QTcF interval over 450 msec or major EKG abnormalities
- Active autoimmune anemia or thrombocytopenia
- Uncontrolled illnesses such as liver cirrhosis or autoimmune disorders requiring immunosuppression
- Severe lung disease
- Concurrent cancers requiring active treatment
- Certain prior malignancies within past 3 years except specified exceptions
- Active infections requiring systemic therapy
- Pregnant or breastfeeding women
- Known active HIV or active hepatitis B or C infection not meeting study criteria
- Impaired decision-making capacity
- Use of strong CYP3A inducers
- Medical conditions making study drug use unsafe or affecting toxicity interpretation
- Inability to swallow capsules or serious gastrointestinal conditions
- History of severe bleeding disorders
- Recent stroke or brain hemorrhage within 180 days
- Major surgery within 4 weeks before first dose
- Need for warfarin or similar anticoagulants
- Recent or planned live vaccination within 28 days
- Allergies to study drugs or components
- Participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
J
Juan P Alderuccio, MD
CONTACT
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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