NCT05681195

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

Zanubrutinib With Pemetrexed for the Treatment of Relapsed/Refractory Primary and Secondary CNS Lymphomas: A Phase II Trial With a Safety Lead-In

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Pemetrexed, when used by itself, is beneficial and is a standard of care therapy for RR PCNSL and can be used to treat SCNSL. Zanubrutinib is an oral drug that is approved by the Food and Drug Administration (FDA) as safe and effective to treat certain lymphoma types.

Conditions

• Primary Central Nervous System Lymphoma
• Secondary Central Nervous System Lymphoma
• Relapsed Cancer
• Refractory Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	Participants will receive 900 mg/m\^2 via IV infusion over 10 minutes every 3 weeks x 4-8 induction cycles (21 days per cycle) as part of the induction therapy.
DRUG	Zanubrutinib	Participants will receive 320 mg PO daily or dose-adjusted when given concomitantly with CYP3A4 inhibitor on Days 3-19 of each induction cycle x 4-8 cycles (21 days per cycle) as part of the induction therapy. For those on maintenance therapy, participants will receive 320 mg PO daily or dose-adjusted when given concomitantly with CYP3A4 inhibitor on Days 1-28 of each maintenance cycle (28 days per cycle) until the transplant (if applicable) or disease progression.
PROCEDURE	Autologous Stem Cell Transplant (ASCT)	ASCT will occur in participants who are candidates for this procedure according to standard of care institutional protocols
RADIATION	Whole Brain Radiation Therapy (WBRT)	WBRT will occur in participants who are candidates for this procedure but not candidates for ASCT according to standard of care institutional protocols

Timeline

• Start date: 2024-04-25
• Primary completion: 2028-02-01
• Completion: 2033-02-01
• First posted: 2023-01-12
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study