Treating breakthrough invasive fungal infections in blood cancer patients with liposomal amphotericin B versus isavuconazole/posaconazole
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
This project will test whether liposomal amphotericin B or isavuconazole/posaconazole works better and is safer for adults with blood cancers who develop breakthrough invasive fungal infections after antifungal prophylaxis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07135778 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with hematologic malignancies—commonly AML, ALL, or MDS—who develop proven, probable, or possible breakthrough invasive fungal disease after ≥7 days of antifungal prophylaxis and can give informed consent.
Not a fit: Patients under 18, those without breakthrough IFD per the guideline definitions, or those with documented allergy to the study antifungals are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could clarify which antifungal approach provides better outcomes and safer care for breakthrough invasive fungal infections in patients with blood cancers.
How similar studies have performed: Liposomal amphotericin B and modern azoles each have established activity in invasive fungal disease, but direct, real-world head-to-head comparisons for breakthrough IFD in hematologic patients are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.