Patients with large B-cell lymphoma with bulky disease
Conditions
Interventions
Phase I R-CMOP group:R-CMOP regimen
Phase II R-CMOP group:R-CMOP regimen
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18-75 years old, both sexes; 2) Large B-cell lymphoma (LBCL) confirmed by histopathology (5th edition WHO classification of Hematopoietic and lymphocytic Neoplasms); These included diffuse large B-cell lymphoma, not otherwise specified, primary cutaneous DLBCL (leg type), primary mediastinal large B-cell lymphoma, ALK-positive large B-cell lymphoma, intravascular large B-cell lymphoma, mediastinal gray-zone lymphoma, and other aggressive B-cell LBCL deemed by the investigator to be eligible for inclusion and approved by the sponsor; 3) No prior treatment for LBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (excluding local radiotherapy for tumor-related symptoms), and surgical treatment (excluding tumor or pathological biopsy and surgical resection for lymphoma); 4) ECOG PS =7.5cm; 6) Bone marrow function: neutrophil count >=1.5×10^9/L, platelet count >=75×10^9/L, hemoglobin >=80g/L (for patients with bone marrow involvement, neutrophil count >=1.0×10^9/L, platelet count >=50×10^9/L, hemoglobin >=75g/L); 7) Liver and renal function: serum creatinine <=1.5 times upper limit of normal; AST and ALT <=2.5 times the upper limit of normal (<=5 times the upper limit of normal in patients with liver invasion); Total bilirubin <=1.5 times the upper limit of normal (<=3 times the upper limit of normal in patients with liver invasion); 8) An expected survival time of at least 3 months, as judged by the investigator; Understand and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Secondary or transformed lymphoma; 2) Prior hematopoietic stem cell transplantation; 3) Hypersensitivity to any study drug or its components; 4) Cardiac function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval >480ms; b) complete left bundle branch block, degree II or III atrioventricular block; c) severe, uncontrolled arrhythmia requiring medical treatment; d) New York College of Cardiology grade >=III; e) cardiac ejection fraction (LVEF) less than 50% or below the lower limit of the study site laboratory range; f) myocardial infarction, unstable angina, history of severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within 6 months before recruitment; 5) Patients with active chronic hepatitis B or active hepatitis C. Patients who were positive for Hepatitis B SurfaceAntigen (HBsAg) or hepatitis B core Antibody (HBcAb) during the screening period were tested for Hepatitis B Virus (HBV). HBV) DNA testing (no more than 1000 copies /mL); Patients positive for Hepatitis C Virus (HCV) antibody should be tested for HCV RNA (no more than the lower limit of assay detection or 1000 copies /mL); 6) Human immunodeficiency virus (HIV) infection (Hiv-Positive); 7) Uncontrolled systemic diseases (defined as systemic diseases that progress despite clinical treatment, such as advanced infection, uncontrolled hypertension, diabetes, etc.); 8) Previous or current concurrent cancer (except for effectively controlled non-melanoma basal cell skin cancer, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past 5 years); 9) Primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment; 10) Pregnant, lactating women and patients of childbearing age who are unwilling to use contraception; 11) Other circumstances deemed by the investigator to be ineligible for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) for stage II patients;Recommended Phase II Dose of Mitoxantrone hydrochloride liposome (RP2D); | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD) for Phase I;Dose-limiting toxicity (DLT);Incidence and severity of hematologic and nonhematologic adverse events;Objective response rate (ORR) for stage I patients;Complete response rate (CRR);Progression-free survival (PFS);Overall survival(OS);Duration of response (DoR); | — |
Countries
China
Contacts
Public ContactPengcheng He
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed