Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases

The Efficacy and Safety of Liposomal Amphotericin B and Isavuconazole/Posaconazole in the Treatment of Breakthrough Invasive Fungal Disease in Patients With Malignant Hematological Diseases After Antifungal Prophylaxis

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.

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. The research objective of this study is to: 1. Evaluate efficacy: The main objective is to determine the therapeutic effect of L-AmB (liposomal amphotericin B) or Isavuconazole/posaconazole on breakthrough invasive fungal disease, including percentage of patients with favorable overall response, survival rate, median to fever remission time, length of hospital stay, etc.2. Evaluate safety: Study the safety of drugs, including monitoring and recording all adverse events, side effects, and drug-related toxicity. 3. Patient population analysis: Study the differences in response to treatment with liposomal amphotericin B and Isavuconazole/posaconazole among different patient populations (such as different ages, genders, and underlying disease states).

These research objectives will contribute to a comprehensive understanding of the roles of L-AmB and Isavuconazole/posaconazole in the treatment of breakthrough fungal infections, and provide scientific evidence for clinical practice.

Inclusion Criteria:

• 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
• According to the latest definition of MSGERC, breakthrough IFD is defined as any IFD that occurs during exposure to antifungal drugs, including fungal infections outside the spectrum of antifungal activity
• Proven, probable, and possible IFD in accordance with the< The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision) >

Exclusion Criteria:

• 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
• Pregnant patients
• Expected life expectancy is less than 30 days
• Patients deemed ineligible by the investigator due to medical, ethical, or logistical reasons.