NCT07357038 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
| NCT ID | NCT07357038 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Fungal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 38 participants in total. It began in 2025-09-30 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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: * (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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07357038 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Fungal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07357038 currently recruiting?
Yes, NCT07357038 is actively recruiting participants. Contact the research team at yangwenyu@ihcams.ac.cn for enrollment information.
Where is the NCT07357038 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07357038 clinical trial?
NCT07357038 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 38 participants.