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

NCT ID: NCT05777369

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2024-08-31

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.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-CMOP

R-CMOP：Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

375 mg/m2, d0

Mitoxantrone hydrochloride liposome

Intervention Type: DRUG

18 mg/m2, d1

Cyclophosphamide

Intervention Type: DRUG

750 mg/m2, d1

Vincristine/Vindesine

Intervention Type: DRUG

Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1

Prednisone

Intervention Type: DRUG

60 mg/m2, d1\~d5

Interventions

Rituximab

375 mg/m2, d0

Intervention Type: DRUG

Mitoxantrone hydrochloride liposome

18 mg/m2, d1

Intervention Type: DRUG

Cyclophosphamide

750 mg/m2, d1

Intervention Type: DRUG

Vincristine/Vindesine

Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1

Intervention Type: DRUG

Prednisone

60 mg/m2, d1\~d5

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Xu, PhD& MD

Role: PRINCIPAL_INVESTIGATOR

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Central Contacts

JinHua Liang, M.D

Role: CONTACT

1151525490@qq.com

15952032421

Wei Xu, PhD& MD

Role: CONTACT

xuwei10000@hotmail.com

862568136034

Other Identifiers

CSPC-DED-DLBCL-K08

Identifier Type: -

Identifier Source: org_study_id