Liposomal Amphotericin B plus Posaconazole or Isavuconazole for Mucormycosis in Blood Cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
  Tianjin, China Recruiting
• 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

Study contacts

• Study coordinator: Sizhou Feng, professor
• Email: szfeng@ihcams.ac.cn
• Phone: +8618322098556

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.