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 (May 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
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)
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.
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