The Efficacy of CAPCT in Patients With PTCL

NCT07746245 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-SR-420
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral T-Cell Lymphoma

Keywords

PTCL; HDACi

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR）

  The proportion of patients who achieve a CR 、CRu and PR

  Up to 2 years

Secondary Outcomes (4)

• Duration of Response（DoR）

  Up to 2 years

• Progression-Free Survival（PFS）

  From treatment to the end of treatment at 12months

• Overall Survival（OS）

  From treatment to the end of treatment at 24 months

• Adverse Event

  From enrollment to the end of treatment at 24 months

Study Arms (1)

CAPCT

EXPERIMENTAL

chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen)

Drug: Chidamide; Drug: Azacitidine (AZA); Drug: Prednisone; Drug: Cyclophosphamide; Drug: Thalidomide (100mg)

Interventions

Chidamide DRUG

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 .

CAPCT

Azacitidine (AZA) DRUG

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

CAPCT

Prednisone DRUG

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

CAPCT

Cyclophosphamide DRUG

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

CAPCT

Thalidomide (100mg) DRUG

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

CAPCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients who are treatment-naïve or have relapsed/refractory disease.
• \. 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.
• \. Patients aged ≥18 years, male or female.
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.
• \. Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥50×10⁹/L, and hemoglobin ≥70 g/L.
• \. Estimated life expectancy ≥3 months.
• \. Voluntary signing of written informed consent.

You may not qualify if:

• \. Pregnant or lactating women, or fertile patients of childbearing potential who are unwilling to adopt contraceptive measures.
• \. 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).
• \. 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).
• \. Confirmed central nervous system (CNS) involvement by lymphoma.
• \. Receipt of prior myelosuppressive symptomatic treatment within 7 days before enrollment.
• \. Active hemorrhage/bleeding.
• \. Patients with acquired immunodeficiency syndrome (AIDS), syphilis, or active hepatitis B (HBV DNA \>1×10⁵ copies/mL) or hepatitis C.
• \. Receipt of grade II or higher surgery within 3 weeks prior to treatment.
• \. Psychiatric disorders or inability to provide informed consent.
• \. Patients deemed by the investigator to be unsuitable for participation in this trial.
• \. Known allergy to any component of the investigational drug.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Azacitidine; Prednisone; Cyclophosphamide; Thalidomide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Wei Xu

CONTACT

+86 13951699449; xuwei10000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Hematology

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)