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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: CAPCTExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate（ORR）

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

Time frame
Up to 2 years

Secondary outcomes

1

Duration of Response（DoR）

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

Time frame
Up to 2 years
2

Progression-Free Survival（PFS）

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

Time frame
From treatment to the end of treatment at 12months
3

Overall Survival（OS）

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

Time frame
From treatment to the end of treatment at 24 months
4

Adverse Event

AEs

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: