What is zanubrutinib studying for relapsed or refractory CNS lymphoma?

Zanubrutinib is being studied in combination with pemetrexed to evaluate its safety and effectiveness in treating relapsed or refractory primary and secondary central nervous system lymphomas. Researchers want to see how well this treatment controls the disease and affects survival. The study is sponsored by Baptist Health South Florida.

Who may be eligible for this relapsed or refractory CNS lymphoma clinical trial?

Adults aged 18 years or older with confirmed primary or secondary CNS lymphoma and measurable disease may be eligible. Participants should have had previous treatment that was unsuccessful or relapsed. Both men and women can join, but females of childbearing potential must use effective contraception. Please review eligibility criteria for more details.

Is there any cost to participate in this relapsed or refractory CNS lymphoma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any transportation or lodging costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05681195

Zanubrutinib With Pemetrexed for RelapsedRefractory Primary and Secondary CNS Lymphomas Phase II Trial With Safety Lead-In

Led by Baptist Health South Florida · Updated on 2026-03-03

Participants Needed

Research Sites

261 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and effectiveness of combining pemetrexed and zanubrutinib as induction therapy, followed by zanubrutinib alone as maintenance therapy, in adults with relapsed or refractory primary central nervous system lymphoma PCNSL or isolated central nervous system relapse of B cell lymphoma SCNSL. The study observes how well patients respond, whether their disease improves or worsens, and their survival rates while monitoring safety and side effects. Participants receive induction therapy that includes oral zanubrutinib and intravenous pemetrexed over 4 to 8 cycles. After induction, participants are grouped into three cohorts based on standard care one undergoes autologous stem cell transplant ASCT, another receives whole brain radiation therapy WBRT followed by zanubrutinib maintenance, and the last continues with zanubrutinib maintenance alone until disease progression. Throughout the study, participants undergo assessments of their response to treatment, including best overall response rates and complete response rates at various points, lasting up to 5 years. Researchers also monitor progression-free survival, overall survival, and any dose-limiting toxicities. Safety is closely tracked, and participants are followed regularly for up to five years to evaluate long-term outcomes and benefits of the treatment regimen.

CONDITIONS

Brief Title

Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas

Who Can Participate

Age: 18Years +

All Genders

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
Karnofsky performance status (KPS) of 30% or higher (50% or higher if age 60 or older)
Disease progressed during first-line therapy, insufficient response to previous treatment, relapsed after initial treatment, or unable to tolerate previous therapy
No systemic lymphoma detected by PET CT or CT scans
Adequate bone marrow and organ function including ANC ≥ 1.5 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 8 g/dL, liver enzymes ≤ 3 times upper limit, bilirubin ≤ 1.5 times upper limit (or up to 3 times with normal direct bilirubin in Gilbert Syndrome), creatinine clearance > 45 mL/min
Ability to understand and sign informed consent or have consent signed by proxy if unable
Life expectancy of at least 2 months
Females of childbearing potential must use highly effective contraception during and 30 days after treatment and have a negative pregnancy test
Agreement to use contraception for both female and male participants with partners of childbearing potential
Patients with HIV, non-viremic Hepatitis C, or HBcAb positive and HBsAg negative, meeting specific viral load and monitoring criteria

You will not qualify if you...

Serious uncontrolled illness or comorbid condition
Other active systemic malignancy except certain low-risk cancers or those in remission for 3+ years
Concurrent chronic systemic immune or targeted therapy not part of this study
Inability to comply with study requirements
Recent chemotherapy, immunotherapy, or radiation within 2 weeks prior to treatment
Pregnant or lactating women
Liver transaminases more than 3 times normal
Pre-existing immunosuppression or current immunosuppressive treatment above study limits
Active autoimmune anemia or thrombocytopenia
Non-healing wounds, ulcers, or bone fractures
Known bleeding disorders
Recent stroke or significant clotting events within specified timeframes
Use of warfarin or certain blood thinners not stopped 7 days before trial
HIV patients with positive viral load or low CD4 count
Detectable hepatitis B surface antigen
Significant cardiovascular disease
Active infections requiring treatment within 7 days before therapy
Recent use or need for strong CYP3A inhibitors or inducers
Life-threatening illness or organ dysfunction risking safety
Previous treatment with pemetrexed or Bruton's tyrosine kinase inhibitors for lymphoma
Recent vaccination with live or attenuated vaccines
Allergy or hypersensitivity to study drugs or their ingredients

Research Team

Yuliya Linhares, M.D.

Allison Miller

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