A Study of Amphotericin B Liposome for Injection in Patients With Persistent Neutropenia and Fever

• Status: Not yet recruiting
• Trial end date: 2023-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Amphotericin B; Liposomal amphotericin B

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