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

Diffuse Large B-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05777369
• Other study ID #: CSPC-DED-DLBCL-K08
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: JinHua Liang, M.D
• Phone: 15952032421
• Email: 1151525490[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab
375 mg/m2, d0
• Mitoxantrone hydrochloride liposome
18 mg/m2, d1
• Cyclophosphamide
750 mg/m2, d1
• Vincristine/Vindesine
Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
• Prednisone
60 mg/m2, d1~d5

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate(ORR)	Objective response rate (ORR) after 6 cycles of R-CMOP chemotherapy	up to 6 cycles of chemotherapy (each cycle is 21 days)
Secondary	Complete remission rate(CRR)	Complete remission rate(CRR) after 6 cycles of R-CMOP chemotherapy	up to 6 cycles of chemotherapy (each cycle is 21 days)
Secondary	Duration of remission(DOR)	Time from reaching CR or PR for the first time to disease progression	up to 6 cycles of chemotherapy (each cycle is 21 days)
Secondary	Progression-Free-Survival rate	from date of inclusion to date of progression, relapse, or death from any cause	1 year
Secondary	Overall survival rate	from the date of inclusion to date of death, irrespective of cause	1 year
Secondary	Adverse events (AE)	The safety of the drug was evaluated by NCI-CTC AE 5.0 standard	From the first day of medication to 28 days after the last dose