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NCT07746245

PHASE2

The Efficacy of CAPCT in Patients With PTCL

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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).

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-01

Completion Date

2029-07-31

Last Updated

2026-08-05

Healthy Volunteers

Conditions

Peripheral T-Cell Lymphoma

Interventions

DRUG

Chidamide

Chidamide tablets,：Oral administration at a dose of 20 mg (4 tablets) per intake, twice weekly, with an interval of no less than 3 days between the two doses .

DRUG

Azacitidine (AZA)

Subcutaneous injection at a dose of 100 mg/day on Days 1-7

DRUG

Prednisone

Oral administration at a dose of 20 mg/day, taken after breakfast.

DRUG

Cyclophosphamide

Oral administration at a dose of 50 mg/day, taken after lunch.

DRUG

Thalidomide (100mg)

Oral administration at a dose of 100 mg/day, taken before bedtime.

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.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Clinical Research Directory

The Efficacy of CAPCT in Patients With PTCL

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)