The Efficacy of CAPCT in Patients With PTCL

NCT07746245 — Phase 2, Not yet recruiting, 58 participants, The First Affiliated Hospital with Nanjing Medical University

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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.

RegistryNCT07746245
StatusNot yet recruiting
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment58 (Estimated)
SponsorThe First Affiliated Hospital with Nanjing Medical University (Other)
ConditionsPeripheral T-Cell Lymphoma
InterventionsChidamide, Azacitidine (AZA), Prednisone, Cyclophosphamide, Thalidomide (100mg) (Drug)
Datesstart 2026-08-01 (estimated), primary completion 2028-07-31 (estimated), completion 2029-07-31 (estimated), first posted 2026-08-05, last updated 2026-08-05
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Peripheral T-Cell Lymphoma All trials of Chidamide All trials of Azacitidine (AZA)

-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).

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+Arms and interventions

ArmTypeInterventionsDescription
CAPCTExperimentalDrug: Chidamide; Drug: Azacitidine (AZA); Drug: Prednisone; Drug: Cyclophosphamide; Drug: Thalidomide (100mg)chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen)
  • 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.

+Outcome measures

Primary outcomes

  • Objective Response Rate(ORR) [Up to 2 years]: The proportion of patients who achieve a CR 、CRu and PR

Secondary outcomes

  • Duration of Response(DoR) [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.
  • Progression-Free Survival(PFS) [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.
  • Overall Survival(OS) [From treatment to the end of treatment at 24 months]: The time from the start of treatment to death from any cause.
  • Adverse Event [From enrollment to the end of treatment at 24 months]: AEs

+Eligibility

Sex: All, ages: 18 Years to any

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)

FacilityCityCountryStatus
The First Affiliated Hospital of Nanjing Medical UniversityNanjing, JiangsuChina