a study to evaluate the cardiac safety of mitoxantrone hydrochloride liposome injection in the treatment of advanced malignant tumor

Conditions: Advanced Malignant Tumor

Summary: this is a multicenter, open-label, phase ii study to evaluate the cardiac safety of mitoxantrone hydrochloride liposome in patients with advanced malignant tumor who has received at least first-line treatment.

this is a multicenter, open-label, phase ii study to evaluate the cardiac safety of mitoxantrone hydrochloride liposome in patients with advanced malignant tumor who has received at least first-line treatment. about 120 patients will be recruited in this study. patients with solid tumors will receive mitoxantrone hydrochloride liposome 20 mg/m\^2 by an intravenous infusion (iv) every 3 weeks (q3w, 1 cycle). patients with lymphoma will receive mitoxantrone hydrochloride liposome 20 mg/m\^2 by an intravenous infusion (iv) every 4 weeks (q4w, 1 cycle). all the patients will receive the treatment until disease progression, intolerable toxic reaction, death, or withdrawal by investigator's or patient's decision.

Eligibility criteria:
inclusion criteria: 1. patients fully understand and voluntarily participate in this study and sign informed consent; 2. age ≥18 years; 3. histologically confirmed diagnosis of late-stage solid tumor or peripheral t cell lymphoma (ptcl); 4. has received standard first-line treatment; 5. previous treated with anthracyclines, and converted to doxorubicin at equivalent doses. the cumulative dose of doxorubicin is 160 mg/m\^2 \< doxorubicin ≤550 mg/m\^2; 6. eastern cooperative oncology group (ecog) performance status of 0 to 2; 7. adequate organ function: * absolute neutrophil count (anc) \>1.5 10\^9/l; * hemoglobin \> 90 g/l; * platelet count \> 75 10\^9/l; * creatinine \< 1.5 upper limit of normal (uln); * total bilirubin \< 1.5 uln (\< 3 uln in patients with hepatic metastasis); * aspartate aminotransferase (ast) and alanine aminotransferase (alt) \< 2.5 uln (\< 5 uln in patients with hepatic metastasis); 8. patients of childbearing potential must agree to use effective contraceptive measures from screening until 6 months after the end of the last dose; female patients must have a negative pregnancy test before enrolment. exclusion criteria: 1. history of allergy to mitoxantrone hydrochloride or liposomal drugs; 2. other malignant tumors in the past 3 years, excluding cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin that have been radically treated; 3. cerebral or meningeal metastases; 4. hbsag or hbcab positive with hbv dna ≥ 2000 iu/ml, hcv antibody positive with hcv rna above the lower limit of detection of the study center, or human immunodeficiency virus (hiv) antibody positive; 5. life expectancy ≤ 12 weeks; 6. aes from the previous treatment \> grade 1 based on ctcae (except for the toxicity without safety risk judged by the investigator, such as alopecia, hyperpigmentation); 7. cardiac dysfunction, including: 1)long qt interval syndrome; 2)high-degree atrioventricular block; 3)malignant arrhythmia poorly controlled by medication; 4)a history of chronic heart failure with nyha≥3; 5)severe heart valve regurgitation or stenosis requiring treatment; 6)acute coronary syndrome, severe pericardial disease, severe myocardial disease within 6 months prior to screening; 7)poorly controlled hypertension (defined as systolic blood pressure greater than 160 mmhg or diastolic blood pressure greater than100 mmhg, measured ≥3 times, under control of antihypertensive drug); 8)echocardiography showed lvef \< 50%; 8.active bacterial or fungal infection requiring systemic intravenous therapy within 1 week before the first dose; 9.use of other anticancer treatment within 4 weeks prior to the first dose; 10.enrolled in any other clinical trials within 4 weeks prior to the first dose; 11.patients underwent major surgery within 3 months prior to the first dose, or have a surgical schedule during the study period;; 12.thrombosis or thromboembolism within 6 months prior to the first dose; 13.lactating female; 14.serious and/or uncontrolled systemic diseases; 15.not suitable for this study as decided by the investigator due to other reasons.