drugset / Trial / NCT04627753

Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.

NCT04627753 ↗

NaSingle-groupOpen-labelTreatment

Summary

* After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment. * The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration * Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone. * However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half. * Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).

Timeline

Start
2020-11-02
Primary completion
2028-11-02
Completion
2028-11-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 20 mg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous