Invasive fungal disease
Conditions
Interventions
L-AmB therapy:None
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
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
Exclusion criteria: 1. Received AmB formulation for prophylaxis or treatment within the past 30 days. 2. Confirmed allergy/rapid onset severe allergic reaction/intolerance to L-AmB. 3. Has a history of other tumors and has received any treatment for this tumor within the past 3 years. 4. HIV, active hepatitis B and active hepatitis C virus or syphilis infection. 5. Suffering from mental illness or other conditions that prevent cooperation with research, treatment, and monitoring requirements. 6. 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. 7. Researchers believe that patients who are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The favorable response rate at the end of L-AmB therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| The median time to response(complete or partial response);Length of hospital stay;The survival rate at week 12;safety data; | — |
Countries
China
Contacts
Public ContactWenyu Yang
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Outcome results
None listed