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RECRUITING
NCT06517511
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2024-08-01

Completion Date

2028-04

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DRUG

Selinexor Oral Tablet [Xpovio]

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

DRUG

R-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