Treating breakthrough invasive fungal infections in blood cancer patients with liposomal amphotericin B versus isavuconazole/posaconazole

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, controlled, single-center observational study enrolling adults with hematologic malignancies who develop breakthrough invasive fungal disease after at least 7 days of echinocandin or triazole prophylaxis. Treatment choice is determined by the treating clinician and patients receive either liposomal amphotericin B or an azole (isavuconazole or posaconazole), with 36 patients planned for each treatment group. The study will record clinical outcomes including overall response, survival, time to fever resolution, and length of hospital stay, and will systematically capture adverse events and drug-related toxicity. Analyses will compare efficacy and safety between the two treatment approaches and explore differences across subgroups such as age, sex, and underlying hematologic diagnosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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 Recruiting

Study contacts

• Study coordinator: erlie jiang, doctor
• Email: jiangerlie@ihcams.ac.cn
• Phone: 02223608600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Global registry for emerging invasive fungal infections

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  Recruiting University of Cologne · Cologne, North Rhine-Westphalia · NCT01731353

• Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia

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  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Hainan, Hainan · NCT07763054

• Low-dose liposomal amphotericin B to prevent invasive fungal infections in neutropenic children

  This study tests whether giving a fixed low dose of liposomal amphotericin B can prevent invasive fungal infections in children aged 3–17 who are severely neutropenic after hematopoietic stem cell transplantation or similar high-risk conditions.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Haikou, Hainan · NCT07725263

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.