OncoMatch/Clinical Trials/NCT07493109
Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP
Is NCT07493109 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Chidamide and Entecavir Tablets for diffuse large b-cell lymphoma (dlbcl).
Treatment: Chidamide · Entecavir Tablets — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 positive (positive)
CD20-positive
Required: HBV infection (HBsAg positive, HBV DNA positive (>2000 IU/mL), or histopathological evidence of chronic HBV infection (without cirrhosis))
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)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) — first-line
Patients must have achieved complete response (CR) after 6 cycles of R-CHOP chemotherapy
Cannot have received: chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma, or surgical treatment (except for tumor or pathological tissue biopsy and surgical resection not targeting lymphoma)
Exception: local radiotherapy used to relieve tumor-related symptoms; biopsy/surgical resection not targeting lymphoma
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)
Lab requirements
Blood counts
Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L
Kidney function
Serum creatinine (Cr) ≤ 1.5 × ULN
Liver function
Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis)
Cardiac function
No history of clinically significant QTc interval prolongation (males > 450 ms, females > 470 ms), ventricular tachycardia, atrial fibrillation, heart block, myocardial infarction within 1 year, congestive heart failure, or symptomatic coronary artery disease requiring medication
Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; Serum creatinine (Cr) ≤ 1.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis). Exclusion: history of clinically significant QTc interval prolongation (males > 450 ms, females > 470 ms), ventricular tachycardia, atrial fibrillation, heart block, myocardial infarction within 1 year, congestive heart failure, or symptomatic coronary artery disease requiring medication.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07493109 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD20?
Yes, CD20 positive is a required biomarker for enrollment.
Does this trial require HBV?
Yes, HBV infection is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify