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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат CMOP±R
  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(O

Первичные конечные точки

• Complete Response Rate (CRR) [Срок оценки: 3 years]

Вторичные конечные точки (7)

• Overall Response Rate (ORR) [Срок оценки: 3 years]
• Progression-Free-Survival (PFS) [Срок оценки: 3 years]
• Duration of Response (DOR) [Срок оценки: 3 years]
• Overall survival (OS) [Срок оценки: 3 years]
• Progression of disease within 2 years(POD24) [Срок оценки: 3 years]
• Treatment-emergent adverse events (TEAEs) [Срок оценки: From the initiation of the first dose to 28 days after the last dose]
• Changes in cardiac safety indicators [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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);

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06486337 · CSPC-DED-NHL-K03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗