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Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
Sponsor: Sun Yat-sen University
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
Conditions
Interventions
Selinexor Oral Tablet [Xpovio]
Selinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen.
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