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

An Open, Single-arm, Multicenter Study of R-CMOP Protocol for Primary Treatment of Diffuse Large B-cell Lymphoma Based on Cardiac Function Screening

NCT05777369•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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);
+3 more criteria

Key Dates

Start Date

March 1, 2023

Primary Completion Date

August 1, 2023

Completion Date

August 1, 2024

Last Updated

March 21, 2023

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B-cell Lymphoma

Interventions

Rituximab

DRUG

Mitoxantrone hydrochloride liposome

DRUG

Cyclophosphamide

DRUG

Vincristine/Vindesine

DRUG

Prednisone

DRUG

Contacts

JinHua Liang, M.D

CONTACT

15952032421 1151525490@qq.com

Wei Xu, PhD& MD

CONTACT

862568136034 xuwei10000@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

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