OncoMatch/Clinical Trials/NCT04512534
Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
Is NCT04512534 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PD-1 antibody+ HDAC inhibitor for peripheral t-cell lymphoma.
Treatment: PD-1 antibody+ HDAC inhibitor — This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any prior therapy (relapsed/refractory required)
relapsed/refractory Peripheral T-cell lymphoma
Cannot have received: anti-PD-1 antibody combined with HDAC inhibitor
Exception: Patients only received single agent of treatment regime or sequentially received anti-PD-1 and HDAC inhibitor are allowed to enroll
Previous treatment with anti-PD-1 antibody combined with HDAC inhibitor (Patients only received single agent of treatment regime or sequentially received anti-PD-1 and HDAC inhibitor are allowed to enroll)
Cannot have received: grade II or above surgery
Patients who have received grade II or above surgery within 3 weeks before enrollment
Cannot have received: other antitumor therapy (including corticosteroid therapy, immunotherapy)
Exception: if patients received small-molecule targeted drug therapy, they could be included in the study if the drug was discontinued for more than 5 half-lives
Patients who had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of the enrollment (if patients received small-molecule targeted drug therapy, they could be included in the study if the drug was discontinued for more than 5 half-lives), or had not recovered from the previous toxicity
Lab requirements
Blood counts
WBC ≥ 3.5×10^9/L, ANC ≥ 1.5×10^9/L, PLT ≥ 80×10^9/L, HB ≥ 90 g/L. If abnormal due to bone marrow or spleen invasion by lymphoma, enrollment decision can be determined by the investigator
Kidney function
serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥ 50 ml/min
Liver function
total serum bilirubin, ALT and AST ≤ 1.5 times of upper limit of normal
Cardiac function
LVEF ≥ 50%
Adequate medullary hematopoiesis function ( WBC≥3.5×10^9/L, ANC≥1.5×10^9/L, PLT≥80×10^9/L, HB≥90g/L. If the peripheral blood indicators demonstrate abnormal due to bone marrow or spleen invasion by lymphoma, Enrollment decision can be determined by the investigator as appropriate; Adequate hepatic function (total serum bilirubin, ALT and AST≤1.5 times of upper limit of normal); Adequate renal function (serum creatinine≤1.5 times the upper limit of normal, creatinine clearence≥50ml/min); Echocardiography or radionuclide cardia functional test, LVEF≥50%)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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