Diffuse Large B-cell LymphomaNCT05777369
R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma
A study testing Rituximab, Mitoxantrone hydrochloride liposome and Cyclophosphamide in people with Diffuse Large B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Rituximab, Mitoxantrone hydrochloride liposome and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate in the study voluntarily and sign the informed consent (ICF);
- 18 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;
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- 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.).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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
- Being tested
- Rituximab, Mitoxantrone hydrochloride liposome, Cyclophosphamide, Vincristine/Vindesine, Prednisone
- Keywords
- DLBCL, R-CMOP, Mitoxantrone liposome
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
375 mg/m2, d0
Mitoxantrone hydrochloride liposomeDrug
18 mg/m2, d1
CyclophosphamideDrug
750 mg/m2, d1
Vincristine/VindesineDrug
Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
PrednisoneDrug
60 mg/m2, d1~d5
| Study group | Role | What they receive |
|---|---|---|
| R-CMOP | Experimental | R-CMOP：Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone Receives: Drug: Rituximab; Drug: Mitoxantrone hydrochloride liposome; Drug: Cyclophosphamide; Drug: Vincristine/Vindesine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Objective response rate (ORR) after 6 cycles of R-CMOP chemotherapy
Measured: up to 6 cycles of chemotherapy (each cycle is 21 days)
Secondary outcomes (5)
Complete remission rate(CRR)
Complete remission rate(CRR) after 6 cycles of R-CMOP chemotherapy
Measured: up to 6 cycles of chemotherapy (each cycle is 21 days)
Duration of remission(DOR)
Time from reaching CR or PR for the first time to disease progression
Measured: up to 6 cycles of chemotherapy (each cycle is 21 days)
Progression-Free-Survival rate
from date of inclusion to date of progression, relapse, or death from any cause
Measured: 1 year
Overall survival rate
from the date of inclusion to date of death, irrespective of cause
Measured: 1 year
Adverse events (AE)
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard
Measured: From the first day of medication to 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Xu, PhD& MD, Principal investigator, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777369
- Sponsor's protocol ID
- CSPC-DED-DLBCL-K08
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05777369
- Acronym / sponsor ID
- CSPC-DED-DLBCL-K08
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- DLBCL, R-CMOP, Mitoxantrone liposome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CMOP | Experimental | Drug: Rituximab, Drug: Mitoxantrone hydrochloride liposome, Drug: Cyclophosphamide, Drug: Vincristine/Vindesine, Drug: PrednisoneR-CMOP：Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- To participate in the study voluntarily and sign the informed consent (ICF);
- 18 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;
Key exclusion criteria (13 listed)
- 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:
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab375 mg/m2, d0 | Drug | R-CMOP |
| Mitoxantrone hydrochloride liposome18 mg/m2, d1 | Drug | R-CMOP |
| Cyclophosphamide750 mg/m2, d1 | Drug | R-CMOP |
| Vincristine/VindesineVincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1 | Drug | R-CMOP |
| Prednisone60 mg/m2, d1~d5 | Drug | R-CMOP |
Primary outcome
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
5 secondary outcomes
Complete remission rate(CRR)
Time frame: 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)
Progression-Free-Survival rate
Time frame: 1 year
Overall survival rate
Time frame: 1 year
Adverse events (AE)
Time frame: From the first day of medication to 28 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xu, PhD& MD principal investigator
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab, Mitoxantrone hydrochloride liposome and Cyclophosphamide in people with Diffuse Large B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JinHua Liang, M.D (15952032421, 1151525490@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: up to 6 cycles of chemotherapy (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.