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

30 participantsStarted 2023-03

Plain-language 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

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. To participate in the study voluntarily and sign the informed consent (ICF);
✓. 18 years ≤ age ≤80 years;
✓. Expected survival time ≥3 months;
✓. Initial DLBCL confirmed by histopathology;
✓. 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;
✓. ECOG score 0\~2;
✓. 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);
✓. 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);

Exclusion criteria

✕. Hypersensitivity to any study drug or its components;
✕. Uncontrollable systemic diseases (such as progressive infection, uncontrollable hypertension, diabetes, etc.);
✕. Cardiac function and disease conform to one of the following conditions:
✕. Long QTc syndrome or QTc interval \>480 ms;
✕. Complete left bundle branch block, complete right bundle branch block with left anterior branch block, second degree type II, or third degree atrioventricular block;
✕. New York College of Cardiology Grade ≥ III;
✕. 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.
✕. 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);

What they're measuring

Objective Response Rate(ORR)

Timeframe: up to 6 cycles of chemotherapy (each cycle is 21 days)

Trial details

NCT IDNCT05777369

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08

Contact for this trial

JinHua Liang, M.D

15952032421 1151525490@qq.com

View on ClinicalTrials.gov More Diffuse Large B-cell Lymphoma trials