OncoMatch/Clinical Trials/NCT04512534
Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
Is NCT04512534 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT04512534 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 antibody combined with HDAC inhibitor, grade II or above surgery, other antitumor therapy (including corticosteroid therapy, immunotherapy) disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages