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NCT07493109 | RECRUITING | Diffuse Large B-Cell Lymphoma (DLBCL)

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

Ou Bai, MD/PHD

Information provided by (Responsible Party):

Ou Bai, MD/PHD

Brief Summary:

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.

Condition or disease

Diffuse Large B-Cell Lymphoma (DLBCL)

Intervention/treatment

Chidamide

Entecavir Tablets

Phase

PHASE3

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2026-05-30
Estimated Primary Completion Date : 2029-09-30
Estimated Study Completion Date : 2030-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Both sexes, age range ≥18 years and ≤80 years.
  • 2. 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).
  • 3. 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.
  • 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • 5. 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).
  • 6. Life expectancy of at least 6 months, as judged by the investigator.
  • 7. Understand and voluntarily sign a written informed consent form.
Exclusion Criteria
  • 1. Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.
  • 2. 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.
  • 3. Patients who have undergone organ transplantation.
  • 4. Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.
  • 5. Patients with active bleeding.
  • 6. Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions.
  • 7. Patients with active infection, or persistent fever within 14 days before enrollment.
  • 8. Patients who have not completed at least 6 weeks of recovery after major organ surgery.
  • 9. 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).
  • 10. Patients with mental disorders or those from whom informed consent cannot be obtained.
  • 11. Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results.
  • 12. Patients with lymphoma involving the central nervous system (CNS).
  • 13. Patients deemed by the investigator to be unsuitable for participation in this study.
Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP

Location Details

NCT07493109

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Locations

RECRUITING

China, Jilin

The First Bethune Hospital of Jilin University

Changchun, Jilin, China,