Clinical trial · Observational
Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
The Efficacy and Safety of Liposomal Amphotericin B 3-5mg/kg Combined With Posaconazole/Isavuconazole for the Treatment of Mucormycosis in Patients With Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucormycosis in Hematologic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single-arm,multi-center real-world study
- description
- This is a single-arm study where all participants receive the same treatment. Participants will be treated with a combination antifungal regimen comprising: 1. Liposomal Amphotericin B (L-AmB): Dose: 3-5 mg/kg/day administered intravenously (IV). Duration: Daily infusions until clinical stability, with adjustments permitted based on disease severity and tolerability. 2. Posaconazole or Isavuconazole: Formulations: Oral tablets or intravenous (IV) formulations. Dosing: Loading dose: As per product labeling. Maintenance dose: 300 mg (posaconazole) or 200 mg (isavuconazole) once daily. Duration: Continued orally after discontinuation of L-AmB, per clinical judgment.
- interventionNames
- Drug: liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole
Primary outcomes (1)
- measure
- Composite Response Rate at End of liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) Therapy
- timeFrame
- Assessed immediately after discontinuation of liposomal amphotericin B therapy.
- description
- The proportion of participants achieving a composite response, defined as the complete or partial resolution of mucormycosis-related clinical symptoms, radiological improvement (e.g., reduction in lesion size on CT/MRI), and microbiological clearance (e.g., negative fungal cultures or biomarkers).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
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