Using Selinexor with R-CHOP for TP53-mutated DLBCL patients
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)
This study is testing if adding a new drug called selinexor to the standard treatment for people with untreated TP53-mutated diffuse large B-cell lymphoma can help them get better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | rituximab, cyclophosphamide, doxorubicin, prednisone |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06517511 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of selinexor combined with R-CHOP as a first-line treatment for patients with untreated TP53-mutated diffuse large B-cell lymphoma (DLBCL). Participants will undergo 8 cycles of this combination therapy, and those who achieve complete remission will continue with selinexor maintenance therapy. The study aims to determine the complete response rate as the primary endpoint. It is a multi-center, single-arm phase II trial involving multiple locations in China.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed TP53-mutated DLBCL and at least one measurable lesion.
Not a fit: Patients with DLBCL combined with other lymphoma types or those who have previously received XPO1 inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with TP53-mutated DLBCL.
How similar studies have performed: While this approach is novel for TP53-mutated DLBCL, similar combinations have shown promise in other lymphoma types.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Sun yat-sen university cancer center — Guangzhou, Guangdong, China (Recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: QingQing Cai, MD. PhD. — Sun yat-sen university cancer cente
- Study coordinator: QingQing Cai, MD. PhD.
- Email: caiqq@sysucc.org.cn
- Phone: 0086-20-87342823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.