Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly N
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.
| Condition(s) | Diffuse Large B-Cell Lymphoma (DLBCL) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 foll |
| Ages | 70 Years |
| Sex | All |
| Lead sponsor | Ou Bai, MD/PHD |
| Locations | Changchun, Jilin, China |
| Start date | 2026-04-30 |
| NCT ID | NCT07493148 |
| Official listing | https://clinicaltrials.gov/study/NCT07493148 |