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NCT Number: NCT07746245

The Efficacy of CAPCT in Patients With PTCL

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location contact

Wei Xu

CONTACT

[email protected]

13951699449

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 .

Azacitidine (AZA)

Drug

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

Prednisone

Drug

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

Cyclophosphamide

Drug

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

Thalidomide (100mg)

Drug

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

Primary outcomes

  1. Objective Response Rate（ORR）

    Time frame: Up to 2 years

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

Secondary outcomes

  1. Duration of Response（DoR）

    Time frame: Up to 2 years

    The time from the first documented objective response (CR or PR) to the first documented disease progression or death from any cause.

  2. Progression-Free Survival（PFS）

    Time frame: From treatment to the end of treatment at 12months

    The time from the start of treatment to the first documented disease progression or death from any cause, whichever occurs first.

  3. Overall Survival（OS）

    Time frame: From treatment to the end of treatment at 24 months

    The time from the start of treatment to death from any cause.

  4. Adverse Event

    Time frame: From enrollment to the end of treatment at 24 months

    AEs

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Xu

CONTACT

[email protected]

+86 13951699449

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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