Status:
RECRUITING
Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Mucormycosis in Hematologic Malignancies
Eligibility:
All Genders
18-65 years
Brief Summary
This clinical trial, a single-arm prospective study, aims to evaluate the efficacy and safety of liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole in treating adult pat...
Detailed Description
This research aims to test whether combining two antifungal medications-liposomal amphotericin B (given through an IV) and either posaconazole or isavuconazole (available as IV or oral pills)-can effe...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of a hematologic malignancy (e.g., leukemia, lymphoma, myelodysplastic syndrome).
- Proven, probable, or possible invasive mucormycosis according to the 2019 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria.
- Age ≥18 years and ≤65 years at enrollment.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
- No clinically significant organ dysfunction (e.g., renal, hepatic, cardiac) at screening that would preclude protocol-defined therapies.
- Ability to understand the study procedures and provide voluntary written informed consent.
Exclusion
- Prior treatment with non-liposomal amphotericin B formulations (e.g., amphotericin B deoxycholate) for ≥4 days.
- Documented hypersensitivity, severe immediate allergic reaction, or intolerance to liposomal amphotericin B.
- History of a second malignancy (other than the index hematologic malignancy) treated within the past 3 years.
- Active HIV infection, hepatitis B virus (HBV) infection (HBsAg-positive), hepatitis C virus (HCV) infection (RNA-positive), or syphilis.
- Psychiatric disorders, cognitive impairment, or other conditions impairing compliance with study procedures or assessments.
- Pregnant females, breastfeeding females, or individuals of reproductive potential unwilling to use effective contraception during treatment and for ≥3 months post-therapy.
- Serum creatinine ≥2.0 × upper limit of normal (ULN).
- Liver transaminases (ALT/AST) or alkaline phosphatase ≥5.0 × ULN.
- Total bilirubin ≥3.0 × ULN (isolated bilirubin ≥3.0 × ULN is permitted if due to Gilbert's syndrome or hemolysis).
- Patients deemed ineligible by the investigator due to medical, ethical, or logistical reasons.
Key Trial Info
Start Date :
March 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07185503
Start Date
March 25 2025
End Date
January 1 2027
Last Update
September 22 2025
Active Locations (9)
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1
The Second Hospital of Dalian Medical University
Dalian, China
2
The First Affiliated Hospital of Harbin Medical University
Harbin, China
3
Shengjing Hospital of China Medical University
Shenyang, China
4
The First Affiliated Hospital of China Medical University
Shenyang, China