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This study evaluates Selinexor combined with the R-CHOP regimen as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) that carries a TP53 gene mutation. It enrolls patients aged 18 to 80 with a histologically confirmed diagnosis who have not previously received systemic lymphoma therapy. Sponsored by Sun Yat-sen University, the study is in Phase 2 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.