The Efficacy of CAPCT in Patients With PTCL | NCT07746245

NCT07746245

Overview

NCT ID: NCT07746245
Lead Sponsor: The First Affiliated Hospital with Nanjing Medical UniversityOTHER
Official Title: 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.
Brief Summary: 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).

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Jul 31, 2028Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 58Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Wei XuContact
xuwei10000@hotmail.com

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