Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety

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 patients with malignant hematological diseases complicated by mucormycosis. The primary objectives are to determine the proportion of patients achieving complete or partial resolution of mucormycosis symptoms and to identify prognostic factors influencing survival outcomes. Participants will receive the combination therapy, undergo regular monitoring of symptoms, adverse events, and disease progression via radiological and laboratory assessments, and complete follow-up visits to track long-term survival. The study will analyze composite response rates, treatment-related adverse events, and survival data to refine therapeutic strategies for this high-risk population.

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions2

Browse More Trials