Actively Recruiting
Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas
Led by Baptist Health South Florida · Updated on 2026-03-03
15
Participants Needed
1
Research Sites
457 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymphoma (PCNSL) or isolated central nervous system relapse of B cell lymphoma (SCNSL). Assessments include how well people respond to this treatment, whether their disease gets better or worse, and their survival. Safety of this treatment and its side effects also will be assessed.
CONDITIONS
Official Title
Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma with measurable disease
- Cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease
- Histologic confirmation of ocular lymphoma with measurable intracranial tumor
- Karnofsky performance status (KPS) of at least 30% (50% or higher if age 60 or older)
- Disease progressed after first-line chemotherapy/radiotherapy, insufficient response to previous therapy, relapsed after treatment, or unable to tolerate previous therapy due to specific kidney or liver issues
- No systemic lymphoma detected by PET CT or CT scan with contrast
- Adequate bone marrow and organ function as defined by blood counts, liver enzymes, bilirubin, and creatinine clearance
- Ability to understand and sign informed consent or have proxy consent
- Life expectancy of at least 2 months
- Females of childbearing potential must use highly effective contraception during the study and 30 days after last dose, with negative pregnancy test before treatment
- Males with female partners of childbearing potential must use effective contraception or be abstinent/vasectomized
- Patients with HIV must have negative viral load and CD4 count over 400
- Patients with non-viremic Hepatitis C virus
- Patients positive for Hepatitis B core antibody but negative for surface antigen with undetectable HBV DNA and willing to undergo monitoring
You will not qualify if you...
- Serious uncontrolled concurrent illness or comorbid conditions
- Other active systemic cancers except certain low-risk skin or cervical cancers or remote history of cancer over 3 years ago
- Current chronic systemic immune therapy or targeted therapy not part of this study
- Unable to understand or comply with study requirements
- Prior chemotherapy, immunotherapy, radiation, or similar treatments within 2 weeks before study treatment
- Pregnant or breastfeeding
- Liver enzymes over three times the institutional upper limit
- Pre-existing immunosuppression or concurrent immunosuppressive treatment beyond specified allowances
- Active autoimmune anemia or thrombocytopenia
- Non-healing wounds, ulcers, or bone fractures
- Known bleeding disorders like hemophilia
- Recent cerebrovascular events or thrombotic events within specified time frames
- Use of warfarin or vitamin K antagonists without stopping 7 days before trial drug
- HIV patients with detectable viral load or low CD4 count under 400 without specialist care
- Detectable Hepatitis B surface antigen
- Active serious cardiovascular diseases including recent heart attack, unstable angina, severe heart failure, or significant arrhythmias
- Uncontrolled active infections requiring systemic treatment completed less than 7 days before therapy
- Recent use or need for strong CYP3A inhibitors or inducers affecting antifungal prophylaxis
- Life-threatening illnesses or conditions that may risk patient safety or study integrity
- Prior treatment with pemetrexed or BTK inhibitors for lymphoma
- Vaccination with live or attenuated vaccines within 28 days before first dose or during treatment
- Allergic reaction to zanubrutinib, pemetrexed, or their ingredients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
Y
Yuliya Linhares, M.D.
CONTACT
A
Allison Miller
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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