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)
Complete response rate (CRR) — Up to 8 cycles (each cycle is 21 days) To investigate the preliminary anti-tumor efficacy
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.