The goal of this observational study is to evaluate the efficacy the favorable response rate and safety of L-AmB(liposomal amphotericin B) for the treatment of br-IFD(breakthrough invasive fungal disease) in Chinese children and adolescent patients with hematological malignancies receiving triazoles/echinocandins antifungal prophylaxis.
The main question it aims to answer is:
1. Whether the L-AmB have the same efficacy in the treatment of br-IFD in Chinese children and adolescent with hematological malignancies who are receiving triazoles or echinocandins antifungal prophylaxis as in adults(compared with historical data) 2. Whether L-AmB may have better renal safety in Chinese children and adolescent than in adults (compared with historical data).
Chinese children and adolescent with hematological malignancies will taking L-AmB as part of their regular medical care for br-IFD. The efficacy and safety data will be recorded.
The children and adolescent patients with hematological malignancy received echinocandin/triazole for antifungal prophylaxis and diagnosed with br-IFD.
Age: from 1 month to 18 years old.
Diagnosed patients with hematological malignancy.
Received echinocandin/triazole for antifungal prophylaxis at least 7 days.
(a) Received AmB formulation for prophylaxis or treatment within the past 30 days.
breakthrough IFD in children and adolescent patients with hematological malignancies receiving triazoles or echinocandins prophylaxis
Cohort
Prospective
Patients received the Drug: liposomal amphotericin B（AmBisome） for treatment
Drug1. This is a single center, prospective ,single-arm and observational study. 2. Patients who meet the inclusion and exclusion criteria receive liposomal amphotericin B (L-AmB)(AmBisome) for antifungal therapy. Regarding the combination therapy: During the research period, it is allowed to combine with other antifungal drugs in combination and accurately record them. Researchers determine it based on the severity of the underlying disease, the recovery of immune suppression, and clinical response. Regarding the sequential therapy: During the research period, it is allowed to accept sequential therapy with other antifungal drugs and accurately record them. Researchers determine it based on the severity of the underlying disease, the recovery of immune suppression, and clinical response. Regarding the surgical treatment: If the patient's condition permits, surgical treatment can be accepted and explained. Dosage: All medication doses are to be administered in accordance with the drug
The favorable response rate .
Safety data
Monitor and record any adverse reactions that occur during treatment, with adverse reaction names and grades recorded and evaluated according to NCI-CTCAE V 5.0(National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0), including but not limited to the following indicators: clinical symptoms such as infusion reactions; Laboratory tests such as nephrotoxicity related indicators (creatinine, glomerular filtration rate), electrolytes (hypokalemia, hypomagnesemia), hepatotoxicity related indicators (alanine aminotransferase, aspartate aminotransferase, presidential bilirubin, direct bilirubin, indirect bilirubin), electrocardiogram, cardiac enzymes, etc
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Gilead Sciences
Collaborator
