Active — Not RecruitingPhase 2

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

China35 participantsStarted 2024-06-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

What they're measuring

2-year progression-free survival (PFS) rate

Timeframe: 24months

Trial details

NCT IDNCT06550336

SponsorThe First Hospital of Jilin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

View on ClinicalTrials.gov More Peripheral T Cell Lymphoma trials