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

NCT07135778 | Recruiting

• 1 other identifier: QTJC2025031
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Invasive Fungal Disease

Outcome Measures

Primary Outcomes (1)

• The favorable overall responses rate at the end of treatment (proportion of patients achieving complete or partial remission)

  The end of treatment refers to the time when L-AmB or Isavuconazole/posaconazole treatment ends. According to the EORTC/MSG (European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycosis Study Group)efficacy evaluation criteria based on clinical evaluation, the response is divided into complete remission, partial remission, disease stability, disease progression, and death directly related to the study drug or IFD(invasive fungal disease). Effective refers to complete and partial remission.

  through study completion, an average of 2 weeks

Secondary Outcomes (4)

• Survival rate at key time points

  through study completion, an average of 2 weeks

• Time to favorable overall response

  14 days

• Length of hospitalization

  30 days

• incidence of treatment-emergent adverse events

  30 days

Study Arms (2)

Group 1: patients received L-AmB therapy

Dose: 3-5mg/kg/day administered intravenouly(IV). Duration of treatment: Researchers determine based on the severity of the underlying disease, the recovery of immune suppression, and clinical response. All drug dosages are in accordance with the drug instructions.All treatments must be prescribed according to local routine clinical practice, and the preparation and administration of drugs must be carried out in accordance with the instructions and guidelines provided by the manufacturer.

Group 2: patients received isavuconazole/posaconzazole therapy

Foumulations: Oral tablets or intravenous (IV) formulations. Dosing: Loading dose: As per product labeling. Maintenance dose: 300mg (posaconzazole) or 200mg (isavuconazole) once daily. Duration of treatment: Researchers determine based on the severity of the underlying disease, the recovery of immune suppression, and clinical response. All drug dosages are in accordance with the drug instructions. All treatments must be prescribed according to local routine clinical practice, and the preparation and administration of drugs must be carried out in accordance with the instructions and guidelines provided by the manufacturer.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

breakthrough invasive fungal disease in patients with malignant hematological diseases after antifungal prophylaxis

You may qualify if:

• Male or female patients aged ≥ 18 years at the beginning of treatment.
• The patient or their guardian must be able to understand and sign a written informed consent form (which must be obtained before starting any research procedure)
• Blood based diseases, mainly AML( Acute Myeloid Leukemia), ALL(Acute Lymphoblastic Leukemia), MDS(Myelodysplastic Syndromes)
• Breakthrough invasive fungal disease occurs after receiving antifungal prophylaxis with triazole drugs for ≥ 7 days
• According to the latest definition of MSGERC, breakthrough IFD is defined as any IFD that occurs during exposure to antifungal drugs, including fungal infections outside the spectrum of antifungal activity
• Proven, probable, and possible IFD in accordance with the\< The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision) \>

You may not qualify if:

• Confirmed patients with allergies/rapid onset severe allergic reactions/intolerance to L-AmB or isavuconazole /posaconazole
• Serum creatinine level ≥ 2 times the upper limit of normal
• The level of transaminase or alkaline phosphatase is ≥ 5 times the normal upper limit, and bilirubin is ≥ 3 times the normal upper limit
• Patients who are breastfeeding
• Pregnant patients
• Expected life expectancy is less than 30 days
• Patients deemed ineligible by the investigator due to medical, ethical, or logistical reasons.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (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, 300020, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Non-Probability Sample

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Central Study Contacts

erlie jiang, doctor

CONTACT

02223608600; jiangerlie@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 22, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)