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

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• 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

Location