Obinutuzumab Maintenance Therapy for Adults with Primary Central Nervous System Lymphoma After Response to Initial Treatment

What this Trial Is About

Researchers are evaluating maintenance treatment with obinutuzumab in patients who have primary central nervous system lymphoma PCNSL and have responded to first-line high-dose methotrexate-based chemotherapy. This phase II trial focuses on patients with CD20 B-cell PCNSL who have achieved either a complete or partial response to prior treatment. The study aims to determine how maintenance obinutuzumab affects the duration of this response and also examines overall survival, neurocognitive function, quality of life, and neurotoxicity indicators. Participants are randomly assigned to one of two groups. One group receives obinutuzumab intravenously on days 1 and 2 during the first cycle, then on day 1 in subsequent cycles, repeated every 60 days for two years unless the disease progresses or unacceptable side effects occur. The other group is observed for two years without maintenance treatment. Both groups undergo assessments to evaluate the study outcomes. During the study, participants will have brain magnetic resonance imaging MRI to confirm responses, neurocognitive testing using several validated tools, and quality of life questionnaires at the start and up to two years after entering the study. Researchers will monitor progression-free survival, overall survival, neurotoxicity, and treatment safety throughout. Participation involves regular clinic visits for infusions or observation and scheduled assessments over the two-year period.

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