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NCT Number: NCT07135778

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Location status: Recruiting

Location contact

erlie jiang, Doctor

CONTACT

[email protected]

02223608600

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: through study completion, an average of 2 weeks

    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.

Secondary outcomes

  1. Survival rate at key time points

    Time frame: through study completion, an average of 2 weeks

    proportion of participants alive at (1) end of treatment (2) 42 days post-therapy (3)84 days post-therapy. Survival is defined as being free from death due to any cause

  2. Time to favorable overall response

    Time frame: 14 days

    Duration from study enrollment to achievement of a favorable overall response (complete or partial resolution of mucormycosis symptoms, radiological improvement, and microbiological clearance)

  3. Length of hospitalization

    Time frame: 30 days

    Total number of days participants spend hospitalized from enrollment until discharge or death.

  4. incidence of treatment-emergent adverse events

    Time frame: 30 days

    incidence and severity of treatment-emergent adverse events(TEAEs), including nephrotoxicity, hepatotoxicity, infusion reactions, and electrolyte abnormalities, graded per CTCAE V5.0(National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0) criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

erlie jiang, doctor

CONTACT

[email protected]

02223608600

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

The Efficacy and Safety of Liposomal Amphotericin B and Isavuconazole/Posaconazole in the Treatment of Breakthrough Invasive Fungal Disease in Patients With Malignant Hematological Diseases After Antifungal Prophylaxis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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