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

ConditionDiffuse Large B-Cell Lymphoma (DLBCL)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOu Bai, MD/PHD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chidamide

    Drug

    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.

  • Entecavir Tablets

    Drug

    Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Chidamide groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.

Time frame
24 months

Secondary outcomes

1

Overall Response Rate (ORR)

To assess the Overall Response Rate (ORR) referred to Lugano 2014.

Time frame
24 months
2

Overall survival（OS）

Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ou Bai, MD/PHD

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov
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