Selinexor in Combination With MTX+Ritu to Treat R/R CNSL
Trial Parameters
Brief Summary
This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.
Eligibility Criteria
Inclusion Criteria: * Patients must meet all of the following inclusion criteria to be eligible to enroll in this study: 1. Participants must be able to understand and be willing to sign a written informed consent document. 2. Men and woman who are 18-75 years old on the day of consenting to the study. 3. Histologically documented PCNSL and SCNSL secondary to histologically documented systemic diffuse large B-cell lymphoma (DLBCL). 4. Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL. 5. Patients must have response or remain stable disease for 2 months to prior methotrexate-based regimen. 6. Patients who had prior autologous hematopoietic stem cell transplantation are eligible. 7. Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) 28 days prior to cycle1 day 1(C1D1). For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells. 8. Participants must have an E