Status:
UNKNOWN
A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Refractory Central Nervous System Lymphoma
Relapsed Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether Nivolumab given intrathecally is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Detailed Description
This is a case study aiming to recruit 1 patient. This study is indicated for relapsed/refractory primary central nervous system lymphoma. Primary objective is to explore the safety.
Eligibility Criteria
Inclusion
- Subjects with ECOG 0,1,2,3
- Subjects with pathologically confirmed PCNSL with lesion in brain who progressed after or did not respond to at least 1 line of systemic therapy. PCNSL prior therapy may include HD-MTX, HD-MTX-based regimen, high-dose cytarabine, radiation therapy alone as treatment or as part of consolidation therapy, high-dose therapy with autologous stem cell transplant as part of consolidation therapy, and/or intraocular MTX alone or as part of consolidation therapy
- Subject with sufficient function of liver, kidney, heart, lung and hematopoiesis
- Subjects with relapsed PCNSL and are able to receive biopsy
Exclusion
- Subjects that are not DLBCL type pathologically
- Intraocular PCNSL without evidence of brain disease
- Subjects who cannot undergo MRI assessments
- Relapsed PCNSL patients who cannot undergo biopsy
- Biopsy suggests no significant tumor-infiltration T cell or poor PD-1 expression
- Subjects with other malignancy
- Subjects with history of any inflammatory CNS diseases
- Subjects with an active, known, or suspected autoimmune disease
- Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
July 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04845139
Start Date
July 2 2022
End Date
November 30 2022
Last Update
July 7 2022
Active Locations (1)
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1
Jianmin Zhang
Hangzhou, Zhejiang, China, 310000