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RecruitingPrimary Diffuse Large B-Cell Lymphoma of the Central Nervous System

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

Eligible age

18+ yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

No

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About this study

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).

Sponsor: National Cancer Institute (NCI)

You may qualify if…

  • Histologically proven primary CNS diffuse large b-cell lymphoma confirmed by one of the following:
  • Brain biopsy or resection
  • Cerebrospinal fluid
  • Vitreous fluid
  • No prior organ transplantation to exclude post-transplant lymphoproliferative disorders
  • No prior chemotherapy or radiation therapy for lymphoma
  • No prior allogeneic stem cell transplantation
  • Use of systemic corticosteroids (dexamethasone up to 24 mg/day or equivalent) for disease control or improvement of performance status to be tapered as fast as clinically safe after initiation of therapy is permissible

Where it's recruiting

California

Los Angeles · San Francisco

Florida

Coral Gables · Deerfield Beach · Miami · North Miami

Iowa

Ankeny · Carroll · Clive · Des Moines

Louisiana

Baton Rouge

Maine

Portland · Scarborough · South Portland

Michigan

Adrian · Monroe

Missouri

City of Saint Peters · Creve Coeur · St Louis

New York

Lake Success · Manhasset · New York · Syracuse

North Carolina

Chapel Hill

Ohio

Columbus · Toledo

Oklahoma

Oklahoma City

Source: ClinicalTrials.gov · NCT04609046 · last updated 2026-08-10