NCT04421560 Pembrolizumab, Ibrutinib and Rituximab in PCNSL
| NCT ID | NCT04421560 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Primary Central Nervous System Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2020-08-01 |
| Primary Completion | 2026-12-05 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL). The three drugs being used in the study are: * Pembrolizumab (MK3475) * Ibrutinib * Rituximab (or biosimilar)
Eligibility Criteria
Inclusion Criteria: * Participant must be able to understand and willing to sign a written informed consent document. * Participant must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. * Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. * Participant must be at least 18 years old on day of signing informed consent. * Subjects with pathologically confirmed PCNSL who progressed after CNS-directed therapy, primary refractory disease and relapsed disease are allowed. Participants should have evidence of R/R disease on MRI or CSF cytology. Ocular only recurrences are allowed. * Subjects must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Life expectancy of \>3 mont