Maintenance Obinutuzumab in Treating Patients with Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

Active:	No
Cancer Type:	Brain & Spinal Cord Tumor Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT02498951
Trial Phases:	Phase II	Protocol IDs:	IRB00011601 (primary) NCI-2015-01014 ML29496
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	OHSU Knight Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT02498951

Summary

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.

Objectives

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.

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