NCT06517511 Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
| NCT ID | NCT06517511 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2024-08-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
QingQing Cai, MD. PhD.
PRINCIPAL INVESTIGATOR
Sun yat-sen university cancer cente
Frequently Asked Questions
Who can join the NCT06517511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06517511 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06517511 currently recruiting?
Yes, NCT06517511 is actively recruiting participants. Contact the research team at caiqq@sysucc.org.cn for enrollment information.
Where is the NCT06517511 trial being conducted?
This trial is being conducted at Guangzhou, China, Shanghai, China.
Who is sponsoring the NCT06517511 clinical trial?
NCT06517511 is sponsored by Sun Yat-sen University. The principal investigator is QingQing Cai, MD. PhD. at Sun yat-sen university cancer cente. The trial plans to enroll 42 participants.