Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)
NCT Number: NCT06517511
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Interventions: DRUG: Selinexor Oral Tablet [Xpovio]|DRUG: R-CHOP Protocol
Sponsor: Sun Yat-sen University
Collaborators: Fudan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-11
Completion Date: 2028-04
Locations: Sun yat-sen university cancer center, Guangzhou, Guangdong, 510060, China|Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China

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.

Primary Outcome Measures: Complete response rate (CRR), To investigate the preliminary anti-tumor efficacy, Up to 8 cycles (each cycle is 21 days)
Secondary Outcome Measures: Disease-free survival (DFS), To investigate the preliminary anti-tumor efficacy, From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months|Objective response rate (ORR), To investigate the preliminary anti-tumor efficacy, Up to 8 cycles (each cycle is 21 days)|Progression-free survival (PFS), To investigate the preliminary anti-tumor efficacy, From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months|Overall survival (OS), To investigate the preliminary anti-tumor efficacy, From the date of enrollment until the date of death from ant cause, assessed up to 24 months|Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0, To identify the incidence of AE and SAE, Through study completion, an average of 2 years|Duration of response (DOR), To investigate the preliminary anti-tumor efficacy, From date of the first CR or PR to the first documented progressive disease or death, whichever occurred earlier, assessed up to 24 months|Time to response (TTR), To investigate the preliminary anti-tumor efficacy, From the date of enrollment until the first response, assessed up to 24 weeks
Other Outcome Measures: The gene mutations such as DDX3X、TET2、PTPN2 and so on are sequenced by whole genome sequencing, To explore the correlations between gene mutations and response and prognosis, Through study completion, an average of 2 years|The RNA alterations are sequenced by transcriptome sequencing, To explore the correlations between RNA alterations and response and prognosis, Through study completion, an average of 2 years|Genetic classification of DLBCL, To explore the correlations between genetic classification of DLBCL and response and prognosis, Through study completion, an average of 2 years