The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.
Diffuse Large B-cell Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Subjects fully understand and voluntarily participate in this study and sign informed consent Age≥18 years old International Prognostic Index (IPI)>2 Expected survival ≥ 3 months DLBCL initially diagnosed by histopathology meets the following subtypes according to the 2016 WHO classification: (1) Germinal center B-cell-like (GCB) subtype; (2) Non-germinal center B-cell-like (non-GCB) subtype Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for initial treatment At least 1 evaluable or measurable lesion meeting Lugano 2014 criteria: Nodal lesion: Greatest transverse diameter>1.5cm; Extra-nodal lesion: Greatest transverse diameter>1.0cm ECOG Performance Status: 0-1 Bone marrow function: Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥75×10^9/L, Hemoglobin ≥ 80g/L (Patients with bone marrow involvement were judged by the investigator to enter the group) Liver and kidney function: serum creatinine ≤ 1.5×ULN (upper limit of normal); AST and ALT ≤ 2.5×ULN (≤ 5×ULN for subjects with liver metastases); total bilirubin ≤ 1.5×ULN (≤ 3×ULN for subjects with liver metastases). Exclusion Criteria: Hypersensitivity to any study drug or its components Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.) Heart function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Serious and uncontrolled arrhythmias requiring drug treatment, uncontrolled angina with poor drug control and myocardial infarction within 6 months before enrollment; (3) New York Heart Association grade III~IV; (4) Cardiac ejection fraction (LVEF)< 45% Hepatitis B and hepatitis C active infection (HBV DNA above upper limit of normal; HCV antibody positive and HCV RNA above upper limit of normal) Human immunodeficiency virus (HIV) infection (HIV antibody positive) Subjects with other malignant tumors past or present (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors that have been effectively controlled without treatment within the past five years) Subjects suffering from primary or secondary central nervous system (CNS) lymphoma pregnancy, lactation and patients of childbearing age who are unwilling to take contraceptive measures Mental patients or those who cannot obtain informed consent Unsuitable subjects for this study determined by the investigator.
Sites / Locations
- The First Bethune Hospital of Jilin University
Arms of the Study
Arm 1
Experimental
RCMOP
RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment