Primary Central Nervous System Lymphoma, Refractory Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma
Conditions
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.
Interventions
DRUGNivolumab
Nivolumab given intraventricularly
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | On a continuous basis up to 1 month after the first dose of study drug | Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best overall response(BOR) | up to 3 months after the first dose of study drug | Record individual best overall response(BOR), including CR, PR, SD, PD |
Countries
China
Outcome results
None listed