Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma
- Sponsor
- The Lymphoma Academic Research Organisation
- Study ID
- NCT02542514
- Phase
- PHASE2
- Status
- Completed
Conditions
- Intraocular Lymphoma
- Primary Central Nervous Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ibrutinib — DRUGp.o. 560 mg once a day (four 140 mg capsules) for one year (12 cycles of 28 days)
Study Details
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.
Key Dates
- Start date
- Sep 30, 2015
- Status verified
- Apr 2022
- Primary completion
- Aug 31, 2016
- Completion
- Dec 1, 2021
Study Design
- Enrollment
- 52 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Ibrutinibibrutinib in monotherapy 28 days/cycles
Primary Outcome Measure
disease control rate (CR + CRu + PR +SD) [ Time Frame: 2 months ]