💬In plain words
What the trial is, and whether it could suit you
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 eff
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* The children and adolescent patients with hematological malignancy received echinocandin/triazole for antifungal prophylaxis and diagnosed with br-IFD.
1. Age: from 1 month to 18 years old.
2. Diagnosed patients with hematological malignancy.
3. Received echinocandin/triazole for antifungal prophylaxis at least 7 days.
4. Br-IFD is defined as a proven, probable, and possible IFD diagnosed at least 7 days after the start of primary antifungal prophylaxis and by 7 days from the end of primary antifungal prophylaxis. Definitions of proven, probable and possible IFD based on the EORTC/MSG 2020 criteria.
5. ECOG-PS(Eastern Cooperative Oncology Group Performance Status): 0-2 points.
6. There are no organ dysfunction restrictions during the screening period that limit the use of this protocol.
7. The guardian understands the research and signs written informed consent form.
Exclusion Criteria:
* (a) Received AmB formulation for prophylaxis or treatment within the past 30 days.
(b) Confirmed allergy/rapid onset severe allergic reaction/intolerance to L-AmB (c) Has a history of other tumors and has received any treatment for this tumor within the past 3 years (d) HIV, active hepatitis B and active hepatitis C virus or syphilis infection (e) Suffering from mental illness or other conditions that prevent cooperation with research, treatment, and monitoring requirements (f) Serum creatinine level 2 times the upper limit of normal; Liver transaminase or alkaline phosphatase levels 5 times the upper limit of normal, bilirubin levels 3 times the upper limit of normal (g) Researchers believe that patients who are not suitable for inclusion
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What it tests
- Patients received the Drug: liposomal amphotericin B（AmBisome） for treatment
National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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