A Clinical Study Assessing the Efficacy of Chidamide for CD30-positive Peripheral T-cell Lymphoma (PTCL).

A Prospective, Single-center, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Chidamide Monotherapy for Maintenance Therapy in CD30+ Peripheral T-cell Lymphoma (PTCL).

• Objective:This study aims to assess the efficacy and safety of Chidamide as a monotherapy maintenance treatment for patients with newly diagnosed peripheral T-cell lymphoma (PTCL) who have achieved remission or stable disease after initial brentuximab vedotin (BV) plus cyclophosphamide, doxorubicin and prednisone (CHP)treatment, excluding ALK+ anaplastic large-cell lymphoma (ALCL).
• Design: The study is a prospective, single-center, open-label clinical trial.
• Treatment:Eligible patients will receive Chidamide tablets at a dosage of 20 mg (4 tablets) twice weekly. Treatment cycles are 4 weeks long and will continue until disease progression, unacceptable toxicity, patient withdrawal, investigator decision to discontinue, loss to follow-up, death, or study termination.
• Endpoints:The primary endpoint is the 2-year progression-free survival (PFS). Secondary endpoints include the overall response rate (ORR), overall survival (OS), and safety indicators.
• Rationale:The study seeks to provide a basis for the dosing regimen of Chidamide and contribute to the development of effective maintenance treatment strategies for PTCL patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: Chidamide

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. According to the WHO 2016 diagnostic criteria, the histological diagnosis is confirmed as CD30+ peripheral T-cell lymphoma (PTCL), including peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALK- ALCL), enteropathy-associated T-cell lymphoma (EATL), and other pathological subtypes (excluding extranodal NK/T-cell lymphoma, nasal type [NKTCL]). Patients with newly diagnosed PTCL (excluding ALK+ ALCL), who have completed 6 cycles of first-line treatment regimens (including various first-line induction chemotherapy regimens, targeted drugs, other treatment plans, and various combined therapies, etc.; with or without the inclusion of Chidamide) and have achieved complete remission (CR), and are not suitable for or do not consider undergoing autologous hematopoietic stem cell transplantation. Within 12 weeks from the first day of the last cycle of their first-line treatment regimen, they start to receive the medication plan of this study.
2. Age ≥18 years, male or female is not limited;
3. ECOG performance status score 0-3;
4. Neutrophils ≥1.5×10^9/L, platelets ≥80×10^9/L, hemoglobin ≥90g/L;
5. Expected survival time ≥3 months;
6. Voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Pregnant or lactating women and women of childbearing age who are unwilling to adopt contraceptive measures;
2. Patients with a history of clinically significant prolongation of the QTc interval (males > 450ms, females > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), cardiac conduction block, myocardial infarction within the past year, congestive heart failure (CHF), and patients with symptomatic coronary artery disease requiring medication;
3. Patients who have undergone organ transplantation;
4. Patients who have received symptomatic treatment for previous bone marrow toxicity within 7 days prior to enrollment;
5. Patients with active bleeding;
6. Patients with a history of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related diseases;
7. Patients with active infection or those who have had persistent fever within 14 days prior to enrollment;
8. Patients who have undergone major organ surgery within the past 6 weeks;
9. Patients with abnormal liver function (total bilirubin > 1.5 times the normal value, ALT/AST > 2.5 times the normal value, or in liver-infiltrated patients ALT/AST > 5 times the normal value), and abnormal kidney function (serum creatinine > 1.5 times the normal value);
10. Patients with mental disorders/those who are unable to give informed consent;
11. Patients with drug abuse or chronic alcoholism that affects the evaluation of the trial results;
12. Patients with lymphoma involving the central nervous system;
13. Patients deemed by the investigator to be unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chidamide maintenance arm; 20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25. It should be administered orally 30 minutes after meals.	Drug: Chidamide; 20 mg (4 tablets) twice a week, specifically on days 1, 4, 8, 11, 15, 18, 22, and 25.Each 4-week period constitutes one treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year progression-free survival (PFS) rate	PFS was defined as the time between diagnosis and the first date of relapse or all-cause death, whichever occurred first.	24months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	OS was defined as the time after the date of diagnosis until all-cause death.	48months

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: PTCL; chidamide
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: CSIIT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No