Chidamide Plus R-CHOP (CR-CHOP) in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes: A Prospective, Multicenter Phase II Trial
Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes
• Patients must meet all of the following inclusion criteria to be eligible for enrollment:
‣ ≥18 years of age;
⁃ Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
⁃ Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the Other subtype;
⁃ Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
⁃ Measurable lesions identified on cross-sectional imaging through diagnostic modalities (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) are defined as the presence of at least one two-dimensional lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, irrespective of the short-axis diameter;
⁃ The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2;
⁃ Adequate hepatic function is defined as: total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; alkaline phosphatase (ALP) ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 35 mL/min as calculated by the Cockcroft-Gault formula;
⁃ Voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form.