Phase 1 Study Evaluating Lenalidomide and Nivolumab with Rituximab and Methotrexate for Primary CNS Lymphoma Including Follow-Up Maintenance Therapy

What this Trial Is About

Researchers are evaluating the safety, side effects, best dose, and effectiveness of adding lenalidomide and nivolumab to the usual treatment of rituximab and methotrexate in patients with primary central nervous system CNS lymphoma. Lenalidomide may slow or stop tumor growth by blocking blood vessel development, while nivolumab and rituximab are monoclonal antibodies that help the immune system attack cancer cells. This phase I trial aims to improve understanding of these drugs in CNS lymphoma treatment and explore whether maintenance therapy can extend disease control after initial chemotherapy. During the induction phase, patients receive rituximab intravenously on day 1, methotrexate intravenously or orally on day 2, lenalidomide orally daily on days 5 to 9, and nivolumab intravenously on day 14. This 14-day cycle repeats for up to six cycles if the disease does not progress or side effects are unacceptable. Patients with a response or stable disease then enter maintenance therapy, receiving lenalidomide orally daily on days 1 to 21 and nivolumab intravenously on day 1 every 28 days for up to 12 cycles. Various imaging scans and procedures are performed throughout the study for monitoring. Participants undergo MRI scans regularly, CT and PETCT scans during screening, lumbar punctures after induction and maintenance phases, and other tests like bone marrow biopsy and echocardiograms. After completing treatment, patients are followed up every three months for two years, then every six months for an additional two years. Researchers measure outcomes including maximum tolerated dose, treatment response rates, progression-free survival, overall survival, and safety over up to five years.

Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma