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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

NCT07357038 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Fungal Disease

Interventions

DRUG

Patients received the Drug: liposomal amphotericin B（AmBisome） for treatment

1. 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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-02-28
Completion
2027-05-31

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07357038 on ClinicalTrials.gov