Clinical Trial: Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma
Brief 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.
Detailed Summary:
Sponsor: The Lymphoma Academic Research Organisation
Current Primary Outcome: disease control rate (CR + CRu + PR +SD) [ Time Frame: 2 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of AE [ Time Frame: 12 months ]To evaluate tolerance and toxicity of ibrutinib.
- disease control [ Time Frame: 4, 6, 9 and 12 months ]according to IPCG criteria evaluated locally by investigators and the results of the MRI review (maximum of 6 MRI review per patient).
- overall response (OR) [ Time Frame: 4, 6, 9 and 12 months ]according to IPCG criteria evaluated locally by investigators and the results of the MRI review (maximum of 6 MRI review per patient).
- complete response (CR) rate [ Time Frame: 4, 6, 9 and 12 months ]according to IPCG criteria evaluated locally by investigators and the results of the MRI review (maximum of 6 MRI review per patient).
- overall survival (OS) [ Time Frame: 4, 6, 9 and 12 months ]according to IPCG criteria evaluated locally by investigators and the results of the MRI review (maximum of 6 MRI review per patient).
- time to progression [ Time Frame: 12 months ]
- progression-free survival (PFS) [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: The Lymphoma Academic Research Organisation
Dates:
Date Received: August 31, 2015
Date Started: September 2015
Date Completion: January 2019
Last Updated: March 8, 2017
Last Verified: March 2017