Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP

Официальное название

Evaluation of the Efficacy and Safety of Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP: A Prospective, Multicenter, Open-label Phase III Clinical Trial

Обзор

To evaluate the efficacy and safety of chidamide monotherapy as maintenance treatment in patients with diffuse large B-cell lymphoma (DLBCL) and HBV infection following initial response to R-CHOP therapy, and to provide evidence for the clinical application of chidamide.

Подробное описание

Primary endpoint is 2-year progression-free survival (PFS). Secondary endpoints include overall survival (OS), safety parameters, and exploratory biomarkers.

Вмешательства

• Препарат Chidamide
  Chidamide is administered at a dose of 20 mg (4 tablets) twice weekly, i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25, with every 4 weeks constituting one treatment cycle.
• Препарат Entecavir Tablets
  Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: 24 months]

Вторичные конечные точки (2)

• Overall Response Rate (ORR) [Срок оценки: 24 months]
• Overall survival（OS） [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Both sexes, age range ≥18 years and ≤80 years.
• No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy used to relieve tumor-related symptoms), or surgical treatment (except for tumor or pathological tissue biopsy and surgical resection not targeting lymphoma). Patients must have achieved complete response (CR) after 6 cycles of R-CHOP chemotherapy, confirmed by imaging (CT/PET-CT), bone marrow biopsy (if positive at baseline), and clinical assessment. Eligible patients will be randomly assigned in a 1:1 ratio to either the chidamide maintenance treatment group (experimental group) or the observation group (control group).
• Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): Diffuse large B-cell lymphoma (DLBCL), and CD20-positive; Positive result for hepatitis B infection, defined as HBsAg positive, HBV DNA positive (>2000 IU/mL), or histopathological evidence of chronic HBV infection (without cirrhosis). Patients receiving ongoing antiviral therapy (e.g., nucleos(t)ide analogs) must have been on a stable regimen for ≥4 weeks prior to enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the parameters below within 2 weeks prior to assessment): Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis).
• Life expectancy of at least 6 months, as judged by the investigator.
• Understand and voluntarily sign a written informed consent form.

Критерии исключения

• Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.
• Patients with a history of clinically significant QTc interval prolongation (males > 450 ms, females > 470 ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), or symptomatic coronary artery disease requiring medication.
• Patients who have undergone organ transplantation.
• Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.
• Patients with active bleeding.
• Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions.
• Patients with active infection, or persistent fever within 14 days before enrollment.
• Patients who have not completed at least 6 weeks of recovery after major organ surgery.
• Patients with abnormal liver function (total bilirubin > 1.5 × upper limit of normal \[ULN\], ALT/AST > 2.5 × ULN, or > 5 × ULN in patients with liver involvement) or abnormal renal function (serum creatinine > 1.5 × ULN).
• Patients with mental disorders or those from whom informed consent cannot be obtained.
• Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results.
• Patients with lymphoma involving the central nervous system (CNS).
• Patients deemed by the investigator to be unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Bethune Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT07493109 · HBV-DLBCL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗