Actively Recruiting
A Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-01-21
38
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 1 month to 18 years
- Diagnosed with hematological malignancy
- Receiving echinocandin or triazole antifungal prophylaxis for at least 7 days
- Diagnosed with breakthrough invasive fungal disease at least 7 days after starting prophylaxis and within 7 days of its end, based on EORTC/MSG 2020 criteria
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) between 0 and 2
- No organ dysfunction limiting protocol use during screening
- Guardian understands the study and signs informed consent
You will not qualify if you...
- Received amphotericin B formulation for prophylaxis or treatment within the past 30 days
- Known allergy, severe allergic reaction, or intolerance to liposomal amphotericin B
- History of other tumors treated within the past 3 years
- Infection with HIV, active hepatitis B, active hepatitis C, or syphilis
- Mental illness or other conditions preventing cooperation with study procedures
- Serum creatinine level 2 times or higher than normal
- Liver enzyme (transaminase or alkaline phosphatase) levels 5 times or higher than normal
- Bilirubin levels 3 times or higher than normal
- Determined by researchers to be unsuitable for inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
Research Team
W
Wenyu Yang, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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