A single-arm, multi-center, prospective clinical study of mitoxantrone hydrochloride liposome injection-based CMOP±R regimen in the treatment of newly diagnosed Non-Hodgkin's lymphoma
NCT ID NCT06486337
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOP±R in patients with newly diagnosed non-Hodgkin's lymphoma.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 197 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2024
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients fully understand this study, voluntarily participate and sign the informed consent (ICF); * Age: 18-75 years old; * Expected survival time ≥ 3 months; * Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma; * Must have at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter \>1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter \>1.0cm; * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2. * Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count (PLT) ≥75×10\^9/L, Hemoglobin(HB)≥ 80 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\^9/L, Platelet count (PLT) ≥50×10\^9/L, Hemoglobin(HB)≥ 75g/L); * 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 (for patients with liver invasion ≤ 5 times the upper limit of normal value); total bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value); Exclusion Criteria: * Subjects have previously received anthracyclic drug pretreatment; * Hypersensitivity to any study drug or its components; * Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); * Heart function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval \>480 ms; b) complete left bundle branch block, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade ≥ III; e) Cardiac ejection fraction (LVEF) lower than 50%;f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment. * Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x10\^3 copies/mL of hepatitis B virus DNA; more than 1x10\^3 copies/mL of hepatitis C virus RNA); * Human immunodeficiency virus (HIV) infection (positive HIV antibody); * Suffering from other malignant tumors in the past or at the same time (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years); * Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment; * Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; * Other researchers judge not to Eligibility to participate in this study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for NHL are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can pressurized oxygen boost cord blood transplants?
- Engineered immune cells get a boost: new combo therapy targets Hard-to-Treat blood cancers
- New pill hopes to tackle tough lymphoma
- Immunotherapy after chemo may keep aggressive lymphoma at bay
- New cocktail targets tough lymphomas
- Engineered immune cells show promise against tough childhood cancers