a study of amphotericin b liposome for injection in patients with persistent neutropenia and fever

Conditions: Neutropenia and Fever

Summary: this is a multicenter, open-label, single-arm, phase iii study to evaluate the safety and efficacy of amphotericin b liposomes in patients with persistent neutropenia and fever.

this is a multicenter, open-label, single-arm, phase iii study to evaluate the safety and efficacy of amphotericin b liposomes in patients with persistent neutropenia and fever. about 93 patients will be recruited in this study. the patients will receive amphotericin b liposomes intravenous infusion at a dose of 3 mg/kg over 2 hours once daily (qd) for a maximum of 12 weeks.

Eligibility criteria:
inclusion criteria: 1. aged 18 \~ 75 years (inclusive), no gender limitation. 2. patients with neutrophilic deficiency after solid tumor chemotherapy, hematological tumor chemotherapy, hematopoietic stem cell transplantation, etc. (absolute neutrophil count (anc) in peripheral blood \<500 /mm\^3 (0.5×10\^9 /l) for at least 72 hours at screening). 3. persistent or recurrent fever (oral temperature ≥38℃ or axillary temperature ≥37.7℃ within 24 hours prior to randomization) after at least 72 hours on broad-spectrum antibiotics, and considering fever to be associated with suspected fungal infection. 4. female patients must meet one of the following conditions: 1. menopausal patients, menopause at least 1 year; 2. patients of childbearing age: negative for blood/urine pregnancy test before enrollment; agree to take a guaranteed, effective contraception during the study and within 4 weeks after the study. 5. male patients and their partners must use effective contraception throughout the study period and up to 4 weeks after leaving the study. 6. patients fully understand and voluntarily participate in this study and sign informed consent. exclusion criteria: 1. history of allergy to liposomes or amphotericin b. 2. received systemic treatment of amphotericin b or amphotericin b-containing formulation within 10 days prior to enrollment. 3. liposome used within 1 month before the signing informed consent. 4. confirmed or clinically diagnosed invasive fungal infection or known uncontrolled bacteremia or sepsis at screening. 5. eastern cooperative oncology group (ecog) performance status ≥3; 6. abnormal liver function, aspartate aminotransferase (ast)/alanine aminotransferase (alt) ≥5 × the upper limit of normal (uln), or alt/ast ≥3 × uln with total bilirubin ≥1.5 × uln, or total bilirubin ≥3 × uln. 7. serum creatinine \> 2 × uln. 8. serum potassium concentration ≤3.0 mmol/l prior to the first administration, or serum potassium concentration ≤the lower limit of normal value (lln) in patients undergoing digitalization. 9. 12-lead ecg presenting ii or iii degree atrioventricular block, long qt syndrome or corrected qt interval\>480 ms in the absence of a pacemaker. 10. cardiac function grade iii/iv (nyha). 11. tachyarrhythmia requiring intervention and a history of high-risk coronary heart disease such as unstable angina and acute coronary syndrome. 12. human immunodeficiency virus (hiv) antibody or treponema pallidum specific antibody (tpha) positive; active tuberculosis on ct of chest (to be determined by investigator). 13. pregnant or lactating female. 14. a history of drug abuse (non-medical use of narcotic drugs or psychotropic substances) or drug dependence (narcotics, stimulants and psychotropic substances, etc.) within 2 years. 15. plan to use prohibited drugs during the study period. 16. enrolled in any other clinical trials of drugs or medical devices within 3 months prior to screening. 17. life expectancy \< 2 months; 18. not suitable for this study as decided by the investigator due to other reasons