Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases
Institute of Hematology & Blood Diseases Hospital, China
Phase
Observational
Started
2025-05-19
Last updated
2025-08-22
Condition(s) studied
Invasive Fungal Disease
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The favorable overall responses rate at the end of treatment (proportion of patients achieving complete or partial remission) — through study completion, an average of 2 weeks 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.
Trial sites (1)
Facility
City
Region
Status
National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Tianjin
Tianjin Municipality
Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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