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Clinical Trials in China / NCT06517511
Recruiting Phase 2

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

NCT06517511 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2024-08-01
Last updated
2026-02-12

Condition(s) studied

Diffuse Large B Cell Lymphoma

Investigational drug(s) / intervention(s)

Selinexor Oral Tablet [Xpovio] →R-CHOP Protocol →

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Subjects fully understand and voluntarily participate in this study and sign informed consent. * Aged ≥18 and ≤80 years, no gender limitation. * Histologically confirmed DLBCL with TP53 mutations (allowing transformed or concurrent indolent B-cell non-Hodgkin lymphoma) * No prior systemic anti-lymphoma therapy; prior local radiotherapy alone is permitted. * There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2. * Expected survival ≥ 3 months. * Adequate function of bone marrow, liver, and kidney. Exclusion Criteria: * DLBCL with Hodgkin lymphoma, T-cell lymphoma, or other non-B-cell lymphoma; Richter transformation. * DLBCL with central nervous system invasion. * The patients had previously received XPO1 inhibitors. * The patients have contraindications to any drug in the combined treatment. * Patients with chronic active hepatitis B or active hepatitis C. If the background hepatitis B surface antigen (HBsAg) and/or hepatitis B core Antibody (HBcAb) or hepatitis C Virus (HCV) antibody are positive, the further determination for Hepatitis B Virus (HBV) DNA (no more than 2500 copies /mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the assay) can be included. The patients with HBsAg and/or HBcAb positive need to receive anti-HBV drugs. * Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome. * Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug. * Pregnant and lactating women and subjects of childbearing age who do not want to use contraception. * Mentally ill persons or persons unable to obtain informed consent. * Any condition deemed unsuitable by the investigator.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Sun yat-sen university cancer center Guangzhou Guangdong Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06517511 on ClinicalTrials.gov ↗ ← All trials in China