IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, single-arm, prospective phase II study to evaluate the efficacy and safety of a novel combination regimen for relapsed/refractory PCNSL. Specifically, ibrutinib will be administered in combination with ifosfamide, etoposide and rituximab (IBER) as a salvage chemotherapy, which is followed by maintenance ibrutinib monotherapy of fixed duration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deok-Hwan Yang

Criteria

Inclusion Criteria:

• Histologically confirmed PCNSL of CD20+ diffuse large B cell lymphoma (DLBCL)

• PCNSL relapsed or refractory after frontline methotrexate-based chemotherapy (with or without radiation therapy)

• At least one measurable lesion, which is defined as longest diameter of lesion > 0.5 cm, by contrast-enhanced MRI

• ECOG performance status 0-2

• Normal function of major organs

Exclusion Criteria:

• PCNSL other than DLBCL

• Primary ocular lymphoma

• PCNSL accompanied by systemic involvement

• Active infection with hepatitis B or C virus

• Known history of human immunodeficiency virus (HIV) infection

• Therapy with myelosuppressive chemotherapy or biologic therapy < 21 days prior to registration