R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma

Trial Title: R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma

NCT ID: NCT05777369

Condition: Diffuse Large B-cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Prednisone
Cyclophosphamide
Rituximab
Vincristine
Mitoxantrone
Vindesine

Conditions: Keywords:
DLBCL
R-CMOP
Mitoxantrone liposome

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Rituximab
Description: 375 mg/m2, d0
Arm group label: R-CMOP

Intervention type: Drug
Intervention name: Mitoxantrone hydrochloride liposome
Description: 18 mg/m2, d1
Arm group label: R-CMOP

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: 750 mg/m2, d1
Arm group label: R-CMOP

Intervention type: Drug
Intervention name: Vincristine/Vindesine
Description: Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
Arm group label: R-CMOP

Intervention type: Drug
Intervention name: Prednisone
Description: 60 mg/m2, d1~d5
Arm group label: R-CMOP

Summary: To evaluate the efficacy and safety of R-CMOP regimen based on mitoxantrone hydrochloride liposome injection in the treatment of newly diagnosed diffuse large B-cell lymphoma (DLBCL) based on cardiac function screening

Detailed description: Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs. Based on the cardiac safety and efficacy of mitoxantrone liposome, the R-CMOP scheme based on Mitoxantrone liposome for the treatment of initial DLBCL based on cardiac function screening has sufficient theoretical basis and is worth exploring.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. To participate in the study voluntarily and sign the informed consent (ICF); 2. 18 years ≤ age ≤80 years; 3. Expected survival time ≥3 months; 4. Initial DLBCL confirmed by histopathology; 5. There must be at least one evaluable or measurable lesion in line with Lugano2014 criteria: lymph node lesion, the length and diameter of detectable lymph node must be greater than 1.5cm; For non-lymph node lesions, the diameter of extrinsic lesions should be > 1.0cm; 6. ECOG score 0~2; 7. Bone marrow function: neutrophil count ≥1.5×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥80 g/L (neutrophil count ≥1.0×10^9/L, platelet count ≥50×10^9/L, hemoglobin ≥75g/L in patients with bone marrow involvement); 8. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion); 9. Cardiac function: 50% ≤ LVEF ≤ 55%, or LVEF>55% patients with cardiovascular disease (including left ventricular enlargement (left ventricular diameter: male>60mm; female>55mm), controllable arrhythmia (first degree atrioventricular block, second degree type I atrioventricular block, atrial fibrillation, atrial flutter, ventricular premature beats (<4000 times/24h, mainly single)), myocarditis, pericarditis, structural heart disease, etc.). Exclusion Criteria: 1. Hypersensitivity to any study drug or its components; 2. Uncontrollable systemic diseases (such as progressive infection, uncontrollable hypertension, diabetes, etc.); 3. Cardiac function and disease conform to one of the following conditions: 1. Long QTc syndrome or QTc interval >480 ms; 2. Complete left bundle branch block, complete right bundle branch block with left anterior branch block, second degree type II, or third degree atrioventricular block; 3. New York College of Cardiology Grade ≥ III; 4. A history of acute myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmias or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction abnormalities within the 6 months prior to treatment. 4. Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^4 copies /mL; HCV RNA over 1x10^4 copies /mL); 5. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 6. Past or present co-existing malignancies (other than non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past five years); 7. Had primary or secondary central nervous system (CNS) lymphoma or had a history of CNS lymphoma at the time of recruitment 8. Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures; 9. Other researchers judged that it was not suitable to participate in this study.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: March 2023

Completion date: August 2024

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05777369