Chidamide as maintenance for HBV-positive diffuse large B‑cell lymphoma after R‑CHOP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 3 trial enrolls adults (18–80) with CD20‑positive DLBCL and evidence of hepatitis B infection who achieved complete response after six cycles of R‑CHOP and assigns them 1:1 to chidamide maintenance or observation. All participants receive entecavir antiviral therapy per protocol to manage HBV and reduce reactivation risk. The primary endpoint is two‑year progression‑free survival, with secondary endpoints including overall survival, safety, and exploratory biomarkers. The trial will monitor relapse rates, HBV control, and treatment tolerability during follow‑up.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Ou Bai, PHD — The First Bethune Hospital of Jilin University
• Study coordinator: Ou Bai, PHD
• Email: oubai16@163.com
• Phone: 15804302602

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ctDNA testing in newly diagnosed DLBCL or HGBL to predict treatment outcomes

  This study checks if measuring circulating tumor DNA in blood after first-line therapy can predict whether the disease will stay away or come back in people with DLBCL or HGBL.

  Recruiting at 2 sites Peking University People's Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07878351

• Proton Therapy for Mediastinal Lymphoma in Denmark

  This study tests whether using proton therapy for mediastinal lymphoma can lower late-toxicity risk compared with photon therapy in adults.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen, Select A State · NCT07817641

• Memory-Enhanced CAR-T Therapy for Relapsed/Refractory Large B-Cell Lymphoma

  This trial tests memory-enhanced 7×19-THEMIS CAR-T cells in adults with relapsed or refractory large B-cell lymphoma to see how safe they are and whether tumors shrink or disappear.

  Recruiting Phase 1/2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07788118

• UB-VV400 with rapamycin in relapsed/refractory B-cell lymphomas

  A phase 1/2 trial tests UB-VV400 plus rapamycin in adults with relapsed or refractory B-cell lymphomas to see if it is safe and shows anti-tumor activity.

  Recruiting at 2 sites Phase 1/2 Umoja Biopharma · Irvine, California and 1 other locations · NCT07735533

• Rocbrutinib and Lacutoclax in B-cell cancers

  This study tests whether Rocbrutinib plus Lacutoclax can help adults with B-cell malignancies, including CLL/SLL, MCL, DLBCL, FL, WM, who have had prior therapy or are treatment-naïve under specific criteria.

  Recruiting Phase 1/2 Guangzhou Lupeng Pharmaceutical Company LTD. · Tianjin · NCT07609862

• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

  This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.