Clinical trial · Interventional
The Efficacy of CAPCT in Patients With PTCL
Multicenter, Single-Arm, Open-Label Clinical Study to Observe the Efficacy of Chidamide Combined With Azacitidine, Prednisone, Cyclophosphamide, and Thalidomide in Patients With Peripheral T-Cell Lymphoma (PTCL) Who Are Intolerant to Standard Chemotherapy.
- 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 study is a multicenter, single-arm, non-randomized, open-label trial designed to evaluate the efficacy and safety of chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) in patients with peripheral T-cell lymphoma (PTCL). A total of 58 patients with PTCL are planned to be enrolled after providing written informed consent and meeting all eligibility criteria. Enrolled patients will receive the CAPCT regimen, with each cycle consisting of 21 days, for a total of 6 cycles. Participants who do not experience disease progression or unacceptable toxicity after 6 cycles of combination therapy will continue to receive the CPCT regimen (chidamide combined with prednisone, cyclophosphamide, and thalidomide) for up to 6 months, followed by chidamide monotherapy as maintenance treatment. The primary efficacy endpoint is objective response rate (ORR).
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 |
|---|---|---|---|
| Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine (AZA) | Drug | Azacitidine | ALIAS |
| Chidamide | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Thalidomide (100mg) | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAPCT
- description
- chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen)
- interventionNames
- Drug: Chidamide
- Drug: Azacitidine (AZA)
- Drug: Prednisone
- Drug: Cyclophosphamide
- Drug: Thalidomide (100mg)
Primary outcomes (1)
- measure
- Objective Response Rate（ORR）
- timeFrame
- Up to 2 years
- description
- The proportion of patients who achieve a CR 、CRu and PR
Secondary outcomes (4)
- measure
- Duration of Response（DoR）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Patients with histopathologically confirmed peripheral T-cell lymphoma (PTCL), with exclusion of NK/T-cell lymphoma. * 2\. Patients who are treatment-naïve or have relapsed/refractory disease. * 3\. Patients who are intolerant to standard chemotherapy regimens for various reasons, including those aged ≥75 years, or those aged \<75 years but deemed by the investigator to be unsuitable for or unable to tolerate chemotherapy. * 4\. Patients aged ≥18 years, male or female. * 5\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. * 6\. Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥50×10⁹/L, and hemoglobin ≥70 g/L. * 7\. Estimated life expectancy ≥3 months. * 8\. Voluntary signing of written informed consent. Exclusion Criteria: * 1\. Pregnant or lactating women, or fertile patients of childbearing potential who are unwilling to adopt contraceptive measures. * 2\. Patients with chronic heart failure of New York Heart Association (NYHA) functional class III or IV; or those with a history of any of the following cardiac conditions within 6 months: acute coronary syndrome; acute heart failure (NYHA functional class III or IV); or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or sudden cardiac death after resuscitation). * 3\. Hepatic dysfunction (total bilirubin \>1.5× the upper limit of normal \[ULN\]; alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\] \>2.0× ULN, or \>5× ULN in patients with hepatic involvement); or renal dysfunction (serum creatinine \>1.5× ULN). * 4\. Confirmed central nervous system (CNS) involvement by lymphoma. * 5\. Receipt of prior myelosuppressive symptomatic treatment within 7 days before enrollment. * 6\. Active hemorrhage/bleeding. * 7\. Patients with acquired immunodeficiency syndrome (AIDS), syphilis, or active hepatitis B (HBV DNA \>1×10⁵ copies/mL) or hepatitis C. * 8\. Receipt of grade II or higher surgery within 3 weeks prior to treatment. * 9\. Psychiatric disorders or inability to provide informed consent. * 10\. Patients deemed by the investigator to be unsuitable for participation in this trial. * 11\. Known allergy to any component of the investigational drug.
References
Publications (0)
Data not yet available