Actively Recruiting
Efficacy and Safety of Liposomal Amphotericin B and Isavuconazole/Posaconazole in Treating Breakthrough Invasive Fungal Disease in Patients With Hematological Malignancies
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-22
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, open-label, controlled, single-center observational study involving adults aged 18 years and older who have hematological malignancies and develop breakthrough invasive fungal disease after receiving at least 7 days of echinocandin or triazole antifungal prophylaxis. The study aims to evaluate the effectiveness and safety of treatment with liposomal amphotericin B or with isavuconazole or posaconazole, depending on the clinical doctor's decision. It seeks to understand differences in treatment responses among various patient groups by age, gender, and underlying disease conditions. Participants receive either liposomal amphotericin B intravenously at doses of 3-5 mg/kg/day, with treatment duration based on disease severity, immune recovery, and clinical response, or oral or intravenous isavuconazole or posaconazole with a loading dose per product labeling followed by a maintenance dose of 300 mg posaconazole or 200 mg isavuconazole once daily. All dosing and administration follow manufacturer instructions and local clinical practice. The study plans to enroll 36 patients in each treatment group for observation. Throughout the study, researchers will assess each patient's overall response rate at the end of treatment, including complete or partial remission, survival rates, time to fever remission, and length of hospital stay. Safety is monitored by recording all adverse events and drug-related toxicity. Participants will be observed for an average of two weeks during treatment, with additional monitoring up to 30 days for hospitalization length and adverse events, contributing to a comprehensive understanding of these treatments in real-world clinical practice.
CONDITIONS
Brief Title
Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older at treatment start
- Ability to understand and sign written informed consent before any research procedure
- Diagnosed with blood cancers such as acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes
- Developed breakthrough invasive fungal disease after at least 7 days of triazole antifungal prophylaxis
- Breakthrough invasive fungal disease defined as any fungal infection occurring during antifungal drug exposure, including infections outside the drug's activity spectrum
- Proven, probable, or possible invasive fungal disease according to Chinese guidelines for patients with hematological disorders and cancers
You will not qualify if you...
- Allergies, rapid severe allergic reactions, or intolerance to liposomal amphotericin B or isavuconazole/posaconazole
- Serum creatinine levels twice or more above the normal upper limit
- Liver enzyme (transaminase or alkaline phosphatase) levels five or more times above normal, or bilirubin three or more times above normal
- Currently breastfeeding
- Pregnant patients
- Life expectancy less than 30 days
- Deemed ineligible by investigators for medical, ethical, or logistical reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on clinical response and disease severity
Participants receive treatment with either liposomal amphotericin B or isavuconazole/posaconazole according to their doctor's decision. Treatment duration is determined based on disease severity, immune recovery, and clinical response.
Visits occur as part of routine clinical care during treatment
Duration - Up to 30 days after treatment
Participants are observed for treatment efficacy and safety, including monitoring of overall response, survival, adverse events, and hospitalization length.
Approximately weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
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, China, 300020
Actively Recruiting
Research Team
E
erlie jiang, doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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