drugset / Trial / NCT02315326

Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Patients With Newly Diagnosed or Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL)

NCT02315326

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to test any good or bad effects of the study drug called of ibrutinib (also known as Imbruvica™). At this stage of this trial, the study is investigating whether Ibrutinib can be incorporated into the established first-line chemotherapy regimen rituximab, methotrexate, vincristine, and procarbazine (R-VMP) in order to further refine the first-line induction therapy for PCNSL, as observed by a superior CRR (complete response rate) (ARM D RECRUITING ONLY)

Timeline

Start
2014-12-08
Primary completion
2026-01-28
Completion
2026-01-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 420 mg Oral
Subject Ibrutinib Small molecule 560 mg Oral
Subject Ibrutinib Small molecule 840 mg Oral
Background Methotrexate Small molecule 3.5 mg/m2
Background Rituximab Monoclonal antibody 500 mg/m2 Intravenous
Background procarbazine Small molecule 100 mg/m2 Oral