This is a prospective, open label, controlled, single center real-world observational study. Adult (aged ≥ 18 years) patients with hematological malignancies develop breakthrough invasive fungal disease after receiving ≥ 7 days of echinocandin or triazole antifungal prophylaxis receive treatment with liposomal amphotericin B or treatment with Isavuconazole or posaconazole according to the clinical doctor's decision. It is planed to collect 36 patients receiving treatment with liposomal amphotericin B and 36 patients receiving treatment with Isavuconazole or posaconazole, and observe their efficacy and safety.
Male or female patients aged ≥ 18 years at the beginning of treatment.
The patient or their guardian must be able to understand and sign a written informed consent form (which must be obtained before starting any research procedure)
Blood based diseases, mainly AML( Acute Myeloid Leukemia), ALL(Acute Lymphoblastic Leukemia), MDS(Myelodysplastic Syndromes)
Breakthrough invasive fungal disease occurs after receiving antifungal prophylaxis with triazole drugs for ≥ 7 days
Confirmed patients with allergies/rapid onset severe allergic reactions/intolerance to L-AmB or isavuconazole /posaconazole
Serum creatinine level ≥ 2 times the upper limit of normal
The level of transaminase or alkaline phosphatase is ≥ 5 times the normal upper limit, and bilirubin is ≥ 3 times the normal upper limit
Patients who are breastfeeding
breakthrough invasive fungal disease in patients with malignant hematological diseases after antifungal prophylaxis
Cohort
Prospective
Not listed
The favorable overall responses rate at the end of treatment (proportion of patients achieving complete or partial remission)
The end of treatment refers to the time when L-AmB or Isavuconazole/posaconazole treatment ends. According to the EORTC/MSG (European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycosis Study Group)efficacy evaluation criteria based on clinical evaluation, the response is divided into complete remission, partial remission, disease stability, disease progression, and death directly related to the study drug or IFD(invasive fungal disease). Effective refers to complete and partial remission.
Survival rate at key time points
proportion of participants alive at (1) end of treatment (2) 42 days post-therapy (3)84 days post-therapy. Survival is defined as being free from death due to any cause
Time to favorable overall response
Duration from study enrollment to achievement of a favorable overall response (complete or partial resolution of mucormycosis symptoms, radiological improvement, and microbiological clearance)
Length of hospitalization
Total number of days participants spend hospitalized from enrollment until discharge or death.
incidence of treatment-emergent adverse events
incidence and severity of treatment-emergent adverse events(TEAEs), including nephrotoxicity, hepatotoxicity, infusion reactions, and electrolyte abnormalities, graded per CTCAE V5.0(National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0) criteria.
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