OncoMatch/Clinical Trials/NCT05833724
Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
Is NCT05833724 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chidamide for relapsed or refractory peripheral t-cell lymphoma.
Treatment: Chidamide — This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation.
Cannot have received: histone deacetylase (HDAC) inhibitor
Have been treated with histone deacetylase (HDAC) inhibitor.
Cannot have received: autologous stem cell transplantation
Exception: within 12 weeks prior to the start of study drug
Have received autologous stem cell transplantation within 12 weeks prior to the start of study drug.
Cannot have received: allogeneic stem cell transplantation
With a history of allogeneic stem cell transplantation.
Cannot have received: antibody therapy
Exception: within 12 weeks prior to the start of study drug
Have not received any antibody therapy within 12 weeks prior to the start of study drug.
Cannot have received: radiotherapy
Exception: within 4 weeks prior to the start of study drug
Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.
Cannot have received: chemotherapy
Exception: within 4 weeks prior to the start of study drug
Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.
Cannot have received: immunotherapy (except for antibody therapy)
Exception: within 4 weeks prior to the start of study drug
Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.
Cannot have received: target therapy
Exception: within 4 weeks prior to the start of study drug
Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.
Lab requirements
Blood counts
absolute neutrophil counts <1500/μl; platelet counts <90 x 1000/μl, hemoglobin <9 g/dl
Kidney function
serum creatinine >1.5 x uln
Liver function
serum total bilirubin >1.5 x uln; alt/ast >2.5 x uln or >5 x uln if liver metastases are present
Cardiac function
history of clinically significant qtc prolongation (>450 ms for males or >470 ms for females), ventricular tachycardia (vt), atrial fibrillation (af), heart block (hb), myocardial infarction (mi) onset within one year, congestive heart failure (chf), or any other symptomatic coronary artery disease requiring treatment; size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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