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.
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of selinexor in combination with R-CHOP for untreated TP53-mutated DLBCL patients. The induction phase consisted of 8 cycles of selinexor in combination with R-CHOP. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with selinexor will be conducted. The primary endpoint is complete response rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Selinexor (60mg po D1, 8) is added from the second cycle of R-CHOP regimen.
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Sun yat-sen university cancer center
Guangzhou, Guangdong, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGComplete response rate (CRR)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 8 cycles (each cycle is 21 days)
Disease-free survival (DFS)
To investigate the preliminary anti-tumor efficacy
Time frame: 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
Time frame: Up to 8 cycles (each cycle is 21 days)
Progression-free survival (PFS)
To investigate the preliminary anti-tumor efficacy
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 2 years
Duration of response (DOR)
To investigate the preliminary anti-tumor efficacy
Time frame: From date of the first CR or PR to the first documented progressive disease or death, whichever occurred earlier, assessed up to 24 months
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Time to response (TTR)
To investigate the preliminary anti-tumor efficacy
Time frame: From the date of enrollment until the first response, assessed up to 24 weeks