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

NCT06550336 | Active Not Recruiting Phase 2

• 1 other identifier: CSIIT-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Peripheral T Cell Lymphoma

Keywords

PTCL; chidamide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall survival (OS)

  48months

Study Arms (1)

Chidamide maintenance arm

EXPERIMENTAL

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

Interventions

Chidamide DRUG

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.

Chidamide maintenance arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, male or female is not limited;
• ECOG performance status score 0-3;
• Neutrophils ≥1.5×10\^9/L, platelets ≥80×10\^9/L, hemoglobin ≥90g/L;
• Expected survival time ≥3 months;
• Voluntarily sign a written informed consent form.

You may not qualify if:

• Pregnant or lactating women and women of childbearing age who are unwilling to adopt contraceptive measures;
• 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;
• Patients who have undergone organ transplantation;
• Patients who have received symptomatic treatment for previous bone marrow toxicity within 7 days prior to enrollment;
• Patients with active bleeding;
• Patients with a history of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related diseases;
• Patients with active infection or those who have had persistent fever within 14 days prior to enrollment;
• Patients who have undergone major organ surgery within the past 6 weeks;
• 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);
• Patients with mental disorders/those who are unable to give informed consent;
• Patients with drug abuse or chronic alcoholism that affects the evaluation of the trial results;
• Patients with lymphoma involving the central nervous system;
• Patients deemed by the investigator to be unsuitable for participation in this study.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Chidamide tablets,the medication is to be taken at a dose of 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. Treatment Duration: Each 4-week period constitutes one treatment cycle. Throughout the trial, all participants will continue to receive treatment until any of the following occurs: disease progression, intolerable adverse reactions, or the participant decides to withdraw.

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)