RecruitingPhase 1Phase 2NCT05698147

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

Selinexor in Combination With Methotrexate and Rituximab for Relapsed /Refractory Central Nervous System (CNS) Lymphoma

Sponsor

Tong Chen, MD

Enrollment

30 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Central Nervous System Lymphoma

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether selinexor — a drug that blocks cancer cells from exporting certain protective proteins — combined with methotrexate and rituximab chemotherapy can treat relapsed or treatment-resistant central nervous system lymphoma (lymphoma involving the brain or spinal fluid). **You may be eligible if...** - You are 18–75 years old - You have primary or secondary CNS lymphoma (large B-cell lymphoma) that has returned or did not respond to previous treatment - Your cancer previously responded to or stayed stable on a methotrexate-based chemotherapy regimen for at least 2 months - You may have had a prior stem cell transplant **You may NOT be eligible if...** - You have had whole-brain radiation therapy - You have significant cognitive impairment or active uncontrolled infection - You have poor bone marrow, liver, or kidney function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelinexor

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.

DRUGRituximab

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

DRUGMethotrexate

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

View Full Details on ClinicalTrials.gov

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NCT05698147

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