The Efficacy of CAPCT in Patients With PTCL
ConditionPeripheral T-Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Chidamide
- Azacitidine (AZA)
- Prednisone
- Cyclophosphamide
- Thalidomide (100mg)
Treatment groups
58 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov