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

March 9, 2023 updated by: The First Affiliated Hospital with Nanjing Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R-CMOP
R-CMOP：Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone
Drug: Rituximab
375 mg/m2, d0
Drug: Mitoxantrone hydrochloride liposome
18 mg/m2, d1
Drug: Cyclophosphamide
750 mg/m2, d1
Drug: Vincristine/Vindesine
Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
Drug: Prednisone
60 mg/m2, d1~d5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate(ORR)
Time Frame: up to 6 cycles of chemotherapy (each cycle is 21 days)
Objective response rate (ORR) after 6 cycles of R-CMOP chemotherapy
up to 6 cycles of chemotherapy (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission rate(CRR)
Time Frame: up to 6 cycles of chemotherapy (each cycle is 21 days)
Complete remission rate(CRR) after 6 cycles of R-CMOP chemotherapy
up to 6 cycles of chemotherapy (each cycle is 21 days)
Duration of remission(DOR)
Time Frame: up to 6 cycles of chemotherapy (each cycle is 21 days)
Time from reaching CR or PR for the first time to disease progression
up to 6 cycles of chemotherapy (each cycle is 21 days)
Progression-Free-Survival rate
Time Frame: 1 year
from date of inclusion to date of progression, relapse, or death from any cause
1 year
Overall survival rate
Time Frame: 1 year
from the date of inclusion to date of death, irrespective of cause
1 year
Adverse events (AE)
Time Frame: From the first day of medication to 28 days after the last dose
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DED-DLBCL-K08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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