Clinical trial NCT05777369: R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma
Official title: An Open, Single-arm, Multicenter Study of R-CMOP Protocol for Primary Treatment of Diffuse Large B-cell Lymphoma Based on Cardiac Function Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL
R-CMOP
Mitoxantrone liposome
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: up to 6 cycles of chemotherapy (each cycle is 21 days)
Secondary outcomes:
measure: Complete remission rate(CRR)
timeFrame: up to 6 cycles of chemotherapy (each cycle is 21 days)
measure: Duration of remission(DOR)
timeFrame: up to 6 cycles of chemotherapy (each cycle is 21 days)
measure: Progression-Free-Survival rate
timeFrame: 1 year
measure: Overall survival rate
timeFrame: 1 year
measure: Adverse events (AE)
timeFrame: From the first day of medication to 28 days after the last dose
Other outcomes:
Locations:
Study officials:
affiliation: The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
name: Wei Xu, PhD& MD
role: PRINCIPAL_INVESTIGATOR
References: