NCT02542514

Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma

Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an open label, prospective, multicenter, phase II study which aims to define ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG) criteria.

Conditions

• Primary Central Nervous Lymphoma
• Intraocular Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	p.o. 560 mg once a day (four 140 mg capsules) for one year (12 cycles of 28 days)

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-08-01
• Completion: 2021-12-01
• First posted: 2015-09-07
• Last updated: 2022-04-14

Locations

10 sites across 1 country: France