Liposomal Amphotericin B plus Posaconazole or Isavuconazole for Mucormycosis in Blood Cancers
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
This study will test whether combining IV liposomal amphotericin B with posaconazole or isavuconazole can treat mucormycosis in adults with blood cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 9 sites (Dalian and 8 other locations) |
| Trial ID | NCT07185503 on ClinicalTrials.gov |
What this trial studies
This is a single-arm prospective observational study enrolling adults with hematologic malignancies who develop mucormycosis. Participants receive liposomal amphotericin B (3–5 mg/kg/day) combined with either posaconazole or isavuconazole given IV or orally, with dosing and duration recorded. Patients undergo regular clinical, laboratory, and radiological monitoring for symptom response, disease progression, and adverse events, and are followed for long-term survival. The study will report composite response rates, treatment-related toxicity, and identify prognostic factors linked to outcomes to inform future care.
Who should consider this trial
Good fit: Adults aged 18–65 with a diagnosed hematologic malignancy and proven, probable, or possible mucormycosis, an ECOG performance status of 0–2, and no major organ dysfunction are the intended participants.
Not a fit: Patients with prior prolonged use of non-liposomal amphotericin B, known hypersensitivity to liposomal amphotericin B, significant renal/hepatic/cardiac dysfunction, poor performance status, or a recent second malignancy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this regimen could improve fungal infection clearance and survival for high-risk patients with hematologic malignancies and mucormycosis.
How similar studies have performed: Amphotericin B–based regimens are guideline-recommended and posaconazole/isavuconazole have demonstrated activity as salvage or step-down options, but prospective evidence for this exact combination is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dalian and 8 other locations
- The Second Hospital of Dalian Medical University — Dalian, China (Not_yet_recruiting)
- The First Affiliated Hospital of Harbin Medical University — Harbin, China (Not_yet_recruiting)
- Shengjing Hospital of China Medical University — Shenyang, China (Not_yet_recruiting)
- The First Affiliated Hospital of China Medical University — Shenyang, China (Not_yet_recruiting)
- Tianjin First Central Hospital — Tianjin, China (Not_yet_recruiting)
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, China (Recruiting)
- Second Hospital of Tianjin Medical University — Tianjin, China (Not_yet_recruiting)
- Tianjin Haihe Hospital — Tianjin, China (Not_yet_recruiting)
- Tianjin Union Medical Center of Nankai University — Tianjin, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Sizhou Feng, professor
- Email: szfeng@ihcams.ac.cn
- Phone: +8618322098556
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.