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
1 other identifier
interventional
30
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 9, 2023
CompletedFirst Posted
Study publicly available on registry
March 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedMarch 21, 2023
March 1, 2023
5 months
March 9, 2023
March 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Complete remission rate(CRR)
up to 6 cycles of chemotherapy (each cycle is 21 days)
Duration of remission(DOR)
up to 6 cycles of chemotherapy (each cycle is 21 days)
Progression-Free-Survival rate
1 year
Overall survival rate
1 year
Adverse events (AE)
From the first day of medication to 28 days after the last dose
Study Arms (1)
R-CMOP
EXPERIMENTALR-CMOP：Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone
Interventions
Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
Eligibility Criteria
You may qualify if:
- To participate in the study voluntarily and sign the informed consent (ICF);
- 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);
- 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.).
You may not qualify if:
- 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);
- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- 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);
- Had primary or secondary central nervous system (CNS) lymphoma or had a history of CNS lymphoma at the time of recruitment
- Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures;
- Other researchers judged that it was not suitable to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Xu, PhD& MD
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2023
First Posted
March 21, 2023
Study Start
March 1, 2023
Primary Completion
August 1, 2023
Study Completion
August 1, 2024
Last Updated
March 21, 2023
Record last verified: 2023-03