Diffuse Large B-cell Lymphoma
Conditions
Keywords
DLBCL, R-CMOP, Mitoxantrone liposome
Brief 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.
Interventions
DRUGRituximab
375 mg/m2, d0
DRUGMitoxantrone hydrochloride liposome
18 mg/m2, d1
DRUGCyclophosphamide
750 mg/m2, d1
Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
DRUGPrednisone
60 mg/m2, d1\ d5
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | up to 6 cycles of chemotherapy (each cycle is 21 days) | Objective response rate (ORR) after 6 cycles of R-CMOP chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate(CRR) | up to 6 cycles of chemotherapy (each cycle is 21 days) | Complete remission rate(CRR) after 6 cycles of R-CMOP chemotherapy |
| Duration of remission(DOR) | up to 6 cycles of chemotherapy (each cycle is 21 days) | Time from reaching CR or PR for the first time to disease progression |
| Progression-Free-Survival rate | 1 year | from date of inclusion to date of progression, relapse, or death from any cause |
| Overall survival rate | 1 year | from the date of inclusion to date of death, irrespective of cause |
| Adverse events (AE) | From the first day of medication to 28 days after the last dose | The safety of the drug was evaluated by NCI-CTC AE 5.0 standard |
Contacts
Primary ContactJinHua Liang, M.D
Backup ContactWei Xu, PhD& MD
Outcome results
None listed