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

Primary Central Nervous System Lymphoma Clinical Trial

Official title:
Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete or Partial Responders

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

  • Lymphoma
  • Primary Central Nervous System Lymphoma
Clinical Trial Details
NCT number NCT06175000
Study type Interventional
Source Providence Health & Services
Contact Tiffany Gervasi-Follmar
Phone 503-216-1023
Email tiffany.gervasi-follmar@providence.org
Status Recruiting
Phase Phase 2
Start date March 13, 2024
Completion date September 15, 2029
View Details
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