CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma

Trial Title: CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma

NCT ID: NCT06486337

Condition: NHL

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin

Conditions: Keywords:
newly diagnosed non-Hodgkin's lymphoma
Mitoxantrone hydrochloride liposome

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: CMOP±R
Description: Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m^2) on day 1, every 4 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m^2) on day 1, every 4 weeks; Drug: Vincristine Vincristine (1.4mg/ m2，Max dose 2mg) will be administered on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 2-3 mg/m2 on day 1), every 4 weeks; Drug: Prednisone Prednisone (100 mg) will be taken orally from day 1-5(Or equivalent dose of dexamethasone at 15mg), every 4 weeks; Drug: Rituximab Rituximab (375mg/m^2) on day 0, every 4 weeks, only with CD20-positive lymphomas are evaluated by the investigator.
Arm group label: CMOP±R

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: July 10, 2024

Completion date: August 31, 2027

Lead sponsor:
Agency: The First Affiliated Hospital of Soochow University
Agency class: Other

Source: The First Affiliated Hospital of Soochow University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06486337