Last updated on September 2018

Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete Response


Brief description of study

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). Monoclonal antibodies, such as obinutuzumab, may kill cancer cells that are left after chemotherapy.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine the effect of maintenance obinutuzumab on duration of complete response (CR) in patients with CD20+ B-cell primary central nervous system lymphoma (PCNSL) who attain CR to first-line treatment with high-dose methotrexate-based chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate overall survival after CR (overall survival [OS]-CR). II. To evaluate neurocognitive function, quality of life, and neuroimaging as indicators of neurotoxicity.

III. Progression-free survival (PFS) and overall survival 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 course, and on day 1 for the subsequent courses. Courses 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 3 years.

After completion of study treatment, patients are followed up every 3 months for 1 year.

Clinical Study Identifier: NCT02498951

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