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RECRUITING
NCT05698147
PHASE1/PHASE2

Selinexor in Combination With MTX+Ritu to Treat R/R CNSL

Sponsor: Tong Chen, MD

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Rituximab

Rituximab 375 mg/m2 intravenous infusion d1, every 28 days for 6 cycles during combination induction treatment.

DRUG

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