NCT06175000

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Cognitive Assessment	Ancillary studies to evaluate neurocognitive function at study entry and at 2 years after study entry.
BIOLOGICAL	Obinutuzumab	Given IV
OTHER	Quality of Life Assessment	Ancillary studies to evaluate quality of life at study entry and at 2 years after study entry.

Timeline

• Start date: 2024-03-13
• Primary completion: 2028-09-15
• Completion: 2029-09-15
• First posted: 2023-12-18
• Last updated: 2025-06-05

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study