Central Nervous System B-Cell Non-Hodgkin Lymphoma Clinical Trial
Official title:
Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete or Partial Responders
This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVE: I. To determine the effect of maintenance obinutuzumab on duration of response (partial response [PR] or complete response [CR]) in patients with CD20+ B-cell primary central nervous system lymphoma (PCNSL) who attain PR or CR to first-line treatment with high-dose methotrexate-based chemotherapy. SECONDARY OBJECTIVES: I. To evaluate overall survival after PR or CR (overall survival [OS]-PRCR). II. To evaluate neurocognitive function, quality of life, and neuroimaging as indicators of neurotoxicity. III. Progression-free survival (PFS) and overall survival (OS) will be calculated. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I (MAINTENANCE THERAPY): Patients receive obinutuzumab intravenously (IV) on days 1 and 2 for the first cycle, and on day 1 for the subsequent cycles. Cycles repeat every 60 days for 2 years in the absence of disease progression or unacceptable toxicity. ARM II (OBSERVATION): Patients undergo observation for a total of 2 years. Study conducted and sponsored by OHSU Knight Cancer Institute from 2016-2024. Study (plus all data for the 32 subjects enrolled to date) transferred over to new coordinating center, Providence Health & Services, as of March, 20, 2024 under duplicate ClinicalTrials.gov ID# NCT06175000. Providence is now Responsible Party and assumes all disclosure responsibilities, including analysis and results posting per FDAAA 801, including for the 32 subjects enrolled at the time of the transfer. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03770416 -
Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma
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Phase 2 |