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

NCT06517511 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-02-12

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • QingQing Cai, MD. PhD. · Sun yat-sen university cancer cente

  • Yi Xia, MD. PhD. · Sun yat-sen university cancer cente

  • Rong Tao, MD. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-01-31
Completion
2028-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06517511 on ClinicalTrials.gov