An Open-Label, Single-Arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy of Azacitidine, Chidamide, and PD-1 Monoclonal Antibody in the Treatment of Refractory/Relapsed Peripheral T-Cell Lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Azacitidine 100 mg is administered subcutaneously once daily from day 1 to day 7. The PD-1 monoclonal antibody 200 mg is administered by intravenous infusion on day 1. Chidamide 20 mg is administered orally twice weekly.
The Second Affiliated Hospital of Soochow University Suzhou
Suzhou, China
RECRUITINGObjective Response Rate (ORR)
To evaluate the objective response rate (ORR) of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
Time frame: From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).
Complete Response Rate (CRR)
To evaluate the complete response rate (CR rate) of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
Time frame: From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).
Progression-free survival(PFS)
To evaluate the progression-free survival (PFS) rate of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
Time frame: Assessed every 12 weeks during the treatment and follow-up period until disease progression or study completion (up to 2 years).
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