Clinical trial · Interventional
Sintilimab Plus Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Phase II Study
Sintilimab Combined With Chidamide in the Treatment of Relapsed and Refractory Cutaneous T-cell Lymphoma: a Multicenter Single Arm Phase II Study
NCT04296786CI-TRIAL-00043827unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of Sintilimab combined with Chidamide in the treatment of relapsed/refractory cutaneous T-cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chidamide plus Sintilimab
- description
- Patients in experimental group will receive fixed does of Sintilimab and Chidamide. This regimen is repeated every 21 days. The response will be evaluated every 2 cycles in the first 36 weeks and every 4 cycles from week 36 till the end of treatment.
- interventionNames
- Drug: Sintilimab
- Drug: Chidamide
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- From date of signing the informed consent until the date of first confirmed progression or date of death from any cause, whichever came first, assessed up to 104 weeks
- description
- ORR was defined as the proportion of patients who achieved CR or PR as their best response.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed cutaneous T-cell lymphoma according World Health Organization (WHO) classification. * ECOG≤2 * Patients with measurable lesions, with or without extra-dermal lesions, clinical stage of IIB-IVB. * Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment. * Absolute neutrophil count (ANC）≥0.75×109/L，platelet (PLT) ≥ 50×109/L，hemoglobin (HGB）≥ 80 g/L * Thyroid stimulating hormone (TSH) within normal range Exclusion Criteria: * Pre-existing uncontrolled active infection * Alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN), total bilirubin (TBIL) \>1.5 times ULN, serum creatinine \>1.5 times ULN * Patients with clinically significant QT interval prolongation (male \> 450ms, female \> 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), acute coronary syndrome (ACS) within 1 year, congestive heart failure (CHF), and symptomatic coronary heart disease. * Patients who have received organ transplantation or hematopoietic stem cell transplantation. * Active bleeding or recent thrombotic disease * Patients with known interstitial lung disease * Patients with active autoimmune disease or history of autoimmune disease in the past 2 years * Patients with CNS involvement * Pregnant or lactating women * History of mental illness
References
Publications (0)
Data not yet available
No reference posted for this study.