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Selinexor in Combination With MTX+Ritu to Treat R/R CNSL
Sponsor: Tong Chen, MD
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.
Official title: Selinexor in Combination With Methotrexate and Rituximab for Relapsed /Refractory Central Nervous System (CNS) Lymphoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-08-03
Completion Date
2026-12-31
Last Updated
2025-09-16
Healthy Volunteers
No
Conditions
Interventions
Selinexor
Selinexor dose escalation: 60,80,100mg respectively on day 1,8,15,22 for 28 days cycles, and dose expansion at the RP2D of Selinexor. PR patients after induction treatment will continue ATG-010 maintenance up to 1 year or until disease progression, intolerable toxicity, death.
Rituximab
Rituximab 375 mg/m2 intravenous infusion d1, every 28 days for 6 cycles during combination induction treatment.
Methotrexate
high-dose Methotrexate 3.5 g/m2 intravenous infusion d1, every 28 days for 6 cycles during combination induction treatment.
Locations (5)
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, China
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Department of Hematology, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China