Actively Recruiting
Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-09-22
60
Participants Needed
9
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of a hematologic malignancy such as leukemia, lymphoma, or myelodysplastic syndrome
- Proven, probable, or possible invasive mucormycosis per 2019 EORTC/MSG criteria
- Age between 18 and 65 years at enrollment
- Eastern Cooperative Oncology Group Performance Status score of 0 to 2
- No significant organ dysfunction (renal, hepatic, cardiac) that prevents study therapies
- Ability to understand study procedures and provide voluntary written informed consent
You will not qualify if you...
- Prior treatment with non-liposomal amphotericin B for 4 or more days
- Known hypersensitivity, severe allergy, or intolerance to liposomal amphotericin B
- History of a second cancer treated within the last 3 years (other than the blood cancer under study)
- Active infections including HIV, hepatitis B (HBsAg-positive), hepatitis C (RNA-positive), or syphilis
- Psychiatric or cognitive conditions impairing study compliance
- Pregnant or breastfeeding women, or those unwilling to use contraception during and 3 months after treatment
- Serum creatinine greater than or equal to 2.0 times the upper limit of normal
- Liver enzyme levels (ALT/AST or alkaline phosphatase) greater than or equal to 5.0 times the upper limit of normal
- Total bilirubin greater than or equal to 3.0 times the upper limit of normal (except for Gilbert's syndrome or hemolysis)
- Any other medical, ethical, or logistical reasons judged by the investigator making the patient ineligible
AI-Screening
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Trial Site Locations
Total: 9 locations
1
The Second Hospital of Dalian Medical University
Dalian, China
Not Yet Recruiting
2
The First Affiliated Hospital of Harbin Medical University
Harbin, China
Not Yet Recruiting
3
Shengjing Hospital of China Medical University
Shenyang, China
Not Yet Recruiting
4
The First Affiliated Hospital of China Medical University
Shenyang, China
Not Yet Recruiting
5
Tianjin First Central Hospital
Tianjin, China, 300020
Not Yet Recruiting
6
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China
Actively Recruiting
7
Second Hospital of Tianjin Medical University
Tianjin, China
Not Yet Recruiting
8
Tianjin Haihe Hospital
Tianjin, China
Not Yet Recruiting
9
Tianjin Union Medical Center of Nankai University
Tianjin, China
Not Yet Recruiting
Research Team
S
Sizhou Feng, professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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