Study on Zanubrutinib and Pemetrexed for Treating Relapsed or Hard-to-Treat Central Nervous System Lymphomas

Sponsor: Baptist Health South Florida

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05681195

Provider View

This clinical trial is testing a combination of two drugs, zanubrutinib and pemetrexed, to see if they can help treat central nervous system lymphomas that have returned or are not responding to treatment. The study will look at how well the treatment works, its safety, and any side effects.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of using two drugs, pemetrexed and zanubrutinib, together to treat central nervous system lymphomas that have come back or are not responding to other treatments. The study will first use both drugs together and then continue with zanubrutinib alone. Researchers will assess how well patients respond to the treatment, whether their condition improves or worsens, and their overall survival. The safety of the treatment and any side effects will also be monitored.

Description

Pemetrexed is a standard treatment for certain types of central nervous system lymphomas, while zanubrutinib is an oral medication approved by the FDA for treating some types of lymphoma. This study aims to see if combining these two drugs can be more effective for patients whose lymphoma has returned or is not responding to other treatments. Participants will first receive both drugs together (induction therapy) and then continue with zanubrutinib alone (maintenance therapy). The study will monitor how well the treatment works, its safety, and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of central nervous system lymphoma, such as primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma, with measurable disease.
  • Have a Karnofsky performance status of at least 30% (or 50% for those aged 60 and older).
  • The lymphoma must have progressed during or after initial treatment, or not responded well to previous treatments.
  • No evidence of systemic lymphoma on PET or CT scans.
  • Adequate bone marrow and organ function, as shown by specific blood test results.
  • Ability to understand and sign informed consent.
  • Life expectancy of at least 2 months.
  • Women of childbearing potential and men must use effective contraception during the study and for 90 days after the last dose of zanubrutinib.
  • For patients with infectious diseases, must have controlled HIV, non-active Hepatitis C, or specific Hepatitis B markers.

Exclusion Criteria

  • Have serious uncontrolled illnesses or other active cancers, except for certain skin or cervical cancers.
  • Currently receiving other immune or targeted therapies not part of this study.
  • Unable to understand or comply with study requirements.
  • Recently participated in other cancer treatments within 2 weeks of starting this study.
  • Pregnant or breastfeeding women.
  • Have liver enzyme levels more than 3 times the normal limit.
  • Have pre-existing immunosuppression or are on certain immunosuppressive treatments, except for low-dose steroids.
  • Have active autoimmune anemia or thrombocytopenia.
  • Have non-healing wounds or bone fractures.
  • Have bleeding disorders or recent strokes or blood clots.
  • Currently using blood thinners like warfarin.
  • Have uncontrolled infections or require systemic treatment for infections within 7 days before starting the study.
  • Have taken certain medications that affect liver enzymes within 7 days before starting the study.
  • Have any life-threatening illnesses or conditions that could affect safety or study results.
  • Have previously been treated with pemetrexed or a BTK inhibitor for lymphoma.
  • Have received live vaccines within 28 days before starting zanubrutinib.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.