Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT05089461
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05089461
Study Brief:
Protocol Section:
NCT05089461