A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma

Primary Central Nervous System Lymphoma Clinical Trial

Official title:

A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04845139
• Other study ID #: 2021-0139
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: November 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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/exclusion criteria could apply

Related Conditions & MeSH terms

• Lymphoma
• Primary Central Nervous System Lymphoma
• Refractory Central Nervous System Lymphoma
• Relapsed Primary Central Nervous System Lymphoma

Intervention

Drug:
• Nivolumab
Nivolumab given intraventricularly

Locations

Country	Name	City	State
China	Jianmin Zhang	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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