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Clinical Trials in China / NCT07493148
Recruiting Phase 2

Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL

NCT07493148 · tracked via the Priya Life Science China tracker
Sponsor
Ou Bai, MD/PHD
Phase
Phase 2
Started
2026-04-30
Last updated
2026-03-25

Condition(s) studied

Diffuse Large B-Cell Lymphoma (DLBCL)

Investigational drug(s) / intervention(s)

Chidamide →Rituximab →Cyclophosphamide →Doxorubicin →Vincristine →Prednisone →Chidamide + Rituximab maintenanceAll Chidamide trials (33) →All Rituximab trials (122) →

Chidamide: Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14.

Rituximab: Rituximab, 375 mg/m² IV, Cycle 1-4, Day 1.

Cyclophosphamide: Cyclophosphamide, 400 mg/m² IV, Cycle 1-4, Day 2.

Doxorubicin: Doxorubicin, 25 mg/m² IV, Cycle 1-4, Day 2.

Vincristine: Vincristine, 1 mg/m² IV, Cycle 1-4, Day 2.

Prednisone: Prednisone, 40 mg/m² orally, Cycle 1-4, Days 1-5.

Chidamide + Rituximab maintenance: Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. Rituximab, 375 mg/m² IV, once every 12 weeks. 21 days/cycle.

Study summary

Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC/BCL2 double-expressor DLBCL.

Eligibility

Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 70 years; 2. No prior treatment for DLBCL; 3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): ① Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), and CD20-positive; ② "MYC/BCL2 double-expressor": Immunohistochemistry (IHC) per WHO criteria: MYC ≥ 40%, and BCL2 ≥ 50%; ③ Non-"double-hit" or "triple-hit" lymphoma; 4. At least one 18F-fluorodeoxyglucose (18FDG)-avid lesion on positron emission tomography-computed tomography (PET-CT) according to the 2014 Lugano classification for Hodgkin and non-Hodgkin lymphoma; 5. International Prognostic Index (IPI) score \> 1; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 7. 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 indicators below within 2 weeks prior to assessment): ① Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; ② 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); 8. Life expectancy ≥ 6 months; 9. Understand and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Central nervous system (CNS) involvement; 2. Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma; specific subtypes of DLBCL (e.g., primary CNS DLBCL, etc.); 3. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases; 4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reactions to murine products; contraindications to any component of the CHOP regimen or chidamide; 5. HIV/HCV infection; 6. If HBsAg is positive, HBV DNA testing is required; patients with negative DNA may be enrolled. If HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV DNA testing is required; patients with negative DNA may be enrolled. 7. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases; 8. Inability to comply with the study protocol due to psychiatric or other unknown reasons; 9. For female patients of childbearing potential or male patients with partners of childbearing potential, unwillingness or inability to use effective contraception throughout the study treatment period and for 12 weeks after the last dose of chidamide or 12 months after the last dose of rituximab, whichever is longer; pregnant or breastfeeding women; 10. Other conditions deemed unsuitable for participation in this trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Bethune Hospital of Jilin University Changchun Jilin Recruiting

On this site

📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

More Ou Bai, MD/PHD trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07493148 on ClinicalTrials.gov ↗ ← All trials in China