RecruitingPhase 2NCT06517511

Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)

Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial (Smart Trial)


Sponsor

Sun Yat-sen University

Enrollment

42 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated TP53-mutated diffuse large B-cell lymphoma (DLBCL) patients.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding selinexor — a drug that blocks cancer cells from exporting certain protective proteins — to the standard R-CHOP chemotherapy regimen improves outcomes for people with newly diagnosed diffuse large B-cell lymphoma (DLBCL) that carries a TP53 mutation. TP53 mutations make this lymphoma more difficult to treat with standard therapy. **You may be eligible if...** - You are 18–80 years old - You have a newly confirmed diagnosis of DLBCL with a TP53 mutation (your doctor can test for this) - You have not had prior systemic (whole-body) lymphoma treatment (prior local radiation alone is acceptable) - You have measurable disease visible on scans **You may NOT be eligible if...** - You have received prior chemotherapy or immunotherapy for lymphoma - Your TP53 mutation has not been confirmed - You have significant liver, kidney, or heart problems that would make R-CHOP or selinexor unsafe 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 Oral Tablet [Xpovio]

Selinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen.

DRUGR-CHOP Protocol

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone


Locations(2)

Sun yat-sen university cancer center

Guangzhou, Guangdong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06517511


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