Clinical trial NCT06486337: CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: NHL
Keywords: newly diagnosed non-Hodgkin's lymphoma
Mitoxantrone hydrochloride liposome
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide, Vincristine, Prednisone and/or Rituximab(CMOP±R) in patients with newly diagnosed non-Hodgkin's lymphoma. Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, prednisone and/or Rituximab. Each cycle consists of 28 days. A maximum of 8 cycles(6×CMOP±R+2×R) of therapy are planned.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete Response Rate (CRR)
timeFrame: 3 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 3 years
measure: Progression-Free-Survival (PFS)
timeFrame: 3 years
measure: Duration of Response (DOR)
timeFrame: 3 years
measure: Overall survival (OS)
timeFrame: 3 years
measure: Progression of disease within 2 years(POD24)
timeFrame: 3 years
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: From the initiation of the first dose to 28 days after the last dose
measure: Changes in cardiac safety indicators
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Soochow University, Suzhou, China
name: Haiwen Huang
role: PRINCIPAL_INVESTIGATOR
References: