Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia

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-center, observational study enrolling 30 adults with hematologic malignancies who develop prolonged neutropenia and are started on 50 mg/day liposomal amphotericin B due to intolerance to other antifungals. The primary outcome is the occurrence of proven or probable invasive fungal disease; secondary outcomes include pneumonia, persistent fever, additional antifungal use, and treatment-related adverse events. Data are collected at baseline and during treatment to assess safety and feasibility of this prophylactic approach. The study does not assign treatment randomly and relies on physician-directed clinical decisions. It aims to characterize real-world use and outcomes of this fixed daily-dose prophylaxis in a high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 75 years (inclusive), both sexes.
* Meets NCCN 2025 V1 guideline criteria for high-risk invasive fungal disease, including allogeneic hematopoietic stem cell transplantation, autologous hematopoietic cell transplantation with mucosal damage, acute leukemia, grade 3/4 graft-versus-host disease, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic lymphocytic leukemia, treatment with purine analogues (fludarabine, clofarabine, nelarabine), chimeric antigen receptor (CAR) T-cell therapy, alemtuzumab therapy, with expected neutropenia \>7 days and accompanied by agranulocytosis.

Note: Agranulocytosis is defined as absolute neutrophil count ≤0.5×10\^9/L, or absolute neutrophil count ≤1×10\^9/L with expected decline to ≤0.5×10\^9/L within 48 hours.

* Assessed by the study physician as having high-risk for invasive fungal infection, intolerant or unable to use other antifungal agents due to toxicity or other reasons, and the treating physician has independently decided in routine clinical practice to initiate liposomal amphotericin B for antifungal prophylaxis for 3-5 days, with the selected dosage regimen of 50 mg/day, intravenous, once daily.
* Patient or legally authorized representative has voluntarily signed the informed consent form.

Exclusion Criteria:

* Allergy to any component of liposomal amphotericin B, or development of serious adverse events during the initial 3-5 days of prophylactic use.
* Prior history of proven or probable invasive fungal disease (IFD).
* Presence of pneumonia, unexplained fever, or clinical/imaging evidence suggestive of or diagnosed as fungal infection during screening.
* Clinically significant hypokalemia (defined as serum potassium \<3.2 mmol/L, or below the lower limit of normal while receiving digitalis therapy) that cannot be corrected before starting trial treatment.
* Hepatic dysfunction with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥5× upper limit of normal (ULN), or total bilirubin ≥3× ULN.
* Renal impairment requiring or currently undergoing hemodialysis or peritoneal dialysis.
* New York Heart Association (NYHA) Class III/IV heart failure.
* Positive for human immunodeficiency virus (HIV) antibody or Treponema pallidum hemagglutination assay (TPHA).
* Expected survival \<3 months.
* Pregnant or breastfeeding women, or women of childbearing potential who are not using contraception and planning pregnancy.
* Any other condition that the investigator considers inappropriate for participation in the clinical trial.

Where it's running

• Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
  Hainan, Hainan, China Recruiting

Study contacts

• Principal investigator: Xiaoyang Yang — Department of Hematology, Haikou People's Hospital
• Study coordinator: Xiaoyang Yang, MD
• Email: y108108@126.com
• Phone: +86-13337647693

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Reduced-intensity conditioning to lower treatment-related mortality in stem cell transplant patients

  This study is testing a new way to prepare patients for a stem cell transplant to see if it can lower the risk of serious treatment-related complications.

  Recruiting Phase 2 Thomas Jefferson University · Philadephia, Pennsylvania · NCT05031897

• Hematopoietic stem cell transplant for blood cancers

  This study is testing two different ways of doing stem cell transplants for people with blood cancers to see which method works better and is safer.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT03314974

• CMV Triplex vaccine to boost immunity and prevent CMV after haploidentical stem cell transplant

  This trial tests whether giving a CMV-MVA Triplex vaccine to donors and/or recipients, with or without the antiviral letermovir, can boost CMV immunity and prevent CMV viremia in people having haploidentical stem cell transplants.

  Recruiting at 3 sites Phase 1 City of Hope Medical Center · Duarte, California and 2 other locations · NCT07020533

• Vaccination to prevent CMV infection in stem cell transplant patients

  This study is testing a new vaccine to see if it can help prevent CMV infections in patients receiving stem cell transplants from related donors.

  Recruiting at 3 sites Phase 2 City of Hope Medical Center · Duarte, California and 2 other locations · NCT06059391

• Long-term study of blood diseases in patients in China

  This study is trying to gather detailed information from patients in China with blood diseases like leukemia and multiple myeloma to better understand how these conditions affect their lives and treatment options.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT04645199

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

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.