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

Diffuse Large B Cell Lymphoma

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

Inclusion Criteria8

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 Criteria10

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.