RecruitingPhase 1Phase 2NCT06556199

A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma

The Efficiency and Safety of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma: A Prospective, Single-arm, Open, Phase Ib/II Clinical Study


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

38 participants

Start Date

Aug 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, single-arm, open label, Phase Ib/II clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed/refractory primary central nervous system lymphoma(PCNSL). Phase Ib used a "3+3" dose-climbing design to confirm the safety, maximum-tolerated dose (MTD,if any) and recommended phaseII dose (RP2D) of selinexor in combination with fixed dose of temozolomide and anti-PD-1 monoclonal antibody for 6 cycles. Phase II was a comprehensive evaluation of efficacy and safety. Subjects who achieved complete remission or partial remission were treated with anti-PD-1 monoclonal antibody maintenance therapy until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — selinexor, temozolomide (a chemotherapy), and an anti-PD-1 immunotherapy — for patients with a rare type of brain and spinal lymphoma called primary central nervous system lymphoma (PCNSL) that has returned or stopped responding to treatment. **You may be eligible if...** - You are aged 18–75 with confirmed B-cell PCNSL - Your lymphoma has come back or stopped responding to at least one prior treatment including methotrexate - You have at least one measurable tumor on MRI - Your blood counts, liver, kidney, and clotting function are within acceptable ranges - Your overall health status is good enough to participate **You may NOT be eligible if...** - You have active brain infection, uncontrolled seizures, or severe neurological conditions - You have received prior anti-PD-1/PD-L1 therapy - You have active hepatitis B, hepatitis C, or HIV - You are pregnant or breastfeeding - You have had a stem cell transplant 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: 40,60,80mg respectively every week, and dose expansion at the RP2D of Selinexor,every 3 weeks for 6 cycles.

DRUGTemozolomide

Temozolomide 150mg/m2 po d1-5 every 3 weeks for 6 cycles.

DRUGAnti-PD-1 monoclonal antibody

The dose of anti-PD-1 monoclonal antibody is fixed dose 200 mg intravenously every 3 weeks until until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, China

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NCT06556199


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