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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab administration | Experimental | Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab given intraventricularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria | On a continuous basis up to 1 month after the first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response(BOR) | Record individual best overall response(BOR), including CR, PR, SD, PD | up to 3 months after the first dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Jianmin Zhang, M.D. | Second Affiliated Hospital, School of Medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianmin Zhang | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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