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

NCT ID: NCT07135778

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2026-12-31

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.

Detailed Description

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. The research objective of this study is to: 1. Evaluate efficacy: The main objective is to determine the therapeutic effect of L-AmB (liposomal amphotericin B) or Isavuconazole/posaconazole on breakthrough invasive fungal disease, including percentage of patients with favorable overall response, survival rate, median to fever remission time, length of hospital stay, etc.2. Evaluate safety: Study the safety of drugs, including monitoring and recording all adverse events, side effects, and drug-related toxicity. 3. Patient population analysis: Study the differences in response to treatment with liposomal amphotericin B and Isavuconazole/posaconazole among different patient populations (such as different ages, genders, and underlying disease states).

These research objectives will contribute to a comprehensive understanding of the roles of L-AmB and Isavuconazole/posaconazole in the treatment of breakthrough fungal infections, and provide scientific evidence for clinical practice.

Conditions

Invasive Fungal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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) >

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Site Status: RECRUITING

Countries

China

Central Contacts

erlie jiang, doctor

Role: CONTACT

jiangerlie@ihcams.ac.cn

02223608600

Facility Contacts

erlie jiang, Doctor

Role: primary

jiangerlie@ihacams.ac.cn

02223608600

Other Identifiers

QTJC2025031

Identifier Type: -

Identifier Source: org_study_id