NCT06517511RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 14 Jul 2024
- Start date
- 1 Aug 2024
- Primary completion date
- Jan 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06517511
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 1 Aug 2024 to the primary completion date, Jan 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patients had previously received XPO1 inhibitors.
- The patients have contraindications to any drug in the combined treatment.
Other illness
- 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.
- Any condition deemed unsuitable by the investigator.
Age
- Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
Other
- DLBCL with Hodgkin lymphoma, T-cell lymphoma, or other non-B-cell lymphoma; Richter transformation.
- DLBCL with central nervous system invasion.
- Mentally ill persons or persons unable to obtain informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.