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Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Started2021-05-24
View on ClinicalTrials.gov ↗
This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).

Amendment history 3 changes detected by DataLookout

2026-09-05
notable
Enrollment closed, study ongoing
2026-04-04
critical
Primary completion pushed: 2026-05-31 → 2027-04-01
2026-04-04
minor
Completion pushed: 2026-05-31 → 2027-04-01
Trial Details
NCT Number NCT04609046
Lead Sponsor National Cancer Institute (NCI)
Conditions Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
Enrollment 47 participants
Start Date 2021-05-24
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-04