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Recruiting Phase 2 NCT04961515

Orelabrutinib, Sintilimab and Temozolomide in Relapsed or Refractory Central Nervous System Lymphoma

Trial Parameters

Condition Primary Central Nervous System Hodgkin Lymphoma
Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 19
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-07-01
Completion 2025-12-31
Interventions
OrelabrutinibSintilimabTemozolomide (TMZ)

Brief Summary

This phase II trial is evaluating the efficacy and side effect of orelabrutinib, sintilimab and temozolomide as possible treatments for relapsed or refractory central nervous system lymphoma.

Eligibility Criteria

Inclusion Criteria: 1. Histologically documented primary central nervous system(CNS) lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) isolated to CNS. 2. Relapsed or refractory disease with at least 1 prior methotrexate-based therapy 3. Participant must be able to understand and willing to sign a written informed consent document. 4. Participant must have signed and dated 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. 5. Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. 6. Participant must be at least 18 years old on day of signing informed consent. 7. PCNSL subjects should have evidence of measurable or evaluable enhancing disease on MRI 8. Able to submit at least 10 but up to 20 unstained formalin-fixed, paraffin-embe

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