Actively Recruiting

Age: 18Years +
All Genders
NCT07135778

Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD( Breakthrough Invasive Fungal Disease) in Patients With Malignant Hematological Diseases

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-22

36

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, open label, controlled, single center real-world observational study. Adult (aged ≥ 18 years) patients with hematological malignancies develop breakthrough invasive fungal disease after receiving ≥ 7 days of echinocandin or triazole antifungal prophylaxis receive treatment with liposomal amphotericin B or treatment with Isavuconazole or posaconazole according to the clinical doctor's decision. It is planed to collect 36 patients receiving treatment with liposomal amphotericin B and 36 patients receiving treatment with Isavuconazole or posaconazole, and observe their efficacy and safety.

CONDITIONS

Official Title

Liposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD( Breakthrough Invasive Fungal Disease) in Patients With Malignant Hematological Diseases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged  18 years at the beginning of treatment
  • Able to understand and sign informed consent before starting the study
  • Diagnosed with blood cancers such as Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes
  • Developed breakthrough invasive fungal disease after  7 days of triazole antifungal prophylaxis
  • Breakthrough invasive fungal disease defined as any fungal infection during antifungal drug exposure
  • Proven, probable, or possible invasive fungal disease according to Chinese guidelines for hematological disorders and cancers
Not Eligible

You will not qualify if you...

  • Allergies, rapid severe allergic reactions, or intolerance to liposomal amphotericin B or isavuconazole/posaconazole
  • Serum creatinine level at least twice the upper limit of normal
  • Liver enzyme levels (transaminase or alkaline phosphatase) at least five times the upper limit of normal, or bilirubin at least three times the upper limit
  • Currently breastfeeding
  • Pregnant
  • Expected life expectancy less than 30 days
  • Deemed ineligible by investigator for medical, ethical, or logistical reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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, 300020

Actively Recruiting

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Research Team

E

erlie jiang, 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

2

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