Status:
UNKNOWN
IBER Salvage Treatment Followed by Ibrutinib Maintenance for Relapsed or Refractory PCNSL
Lead Sponsor:
Deok-Hwan Yang
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
20-79 years
Phase:
PHASE2
Brief 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 administ...
Detailed Description
Given the limited activity of salvage therapy with high-dose methotrexate re-treatment and/or alkylator-based treatment in patients with relapse or refractory PCNSL, the development of novel salvage c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04066920
Start Date
October 1 2019
End Date
September 30 2023
Last Update
August 26 2019
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 519-809