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Open-label single arm phase II study on pembrolizumab for recurrent primary central nervous sytem lymphoma

Phase 2
Withdrawn
Conditions
Primary central nervous system lymphoma
10029211
Registration Number
NL-OMON47301
Lead Sponsor
niversity Vienna, Department of Internal Medicine I, Division of Oncology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
7
Inclusion Criteria

- Histologically confirmed diagnosis of PCNSL (DLBCL) at initial diagnosis.
- Documented progression of recurrence in cranial MRI after prior MTX-based first line therapy (with or without prior radiotherapy).
- The patient demonstrates adequate organ function.

Exclusion Criteria

- Concurrent administration of any other antitumor therapy except steroids.
- Known additional malignancythat is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency etc.) is not considered a form of systemic treatment.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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