Acute Myeloid LeukemiaNCT07763054
Low-dose Liposomal Amphotericin B for Antifungal Prophylaxis in Prolonged Neutropenia Patients
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Haikou Affiliated Hospital of Central South University Xiangya School of Medicine at 1 site in China.
Trial summary
This is a single-center, single-arm, observational clinical study evaluating the efficacy and safety of low-dose liposomal amphotericin B (50 mg/day, intravenous, once daily) for the prevention of invasive fungal infections in adult patients (aged 18-75 years) with hematological malignancies who develop prolonged… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Liposomal Amphotericin B
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 30 Nov 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged 18-75 years) with hematological malignancies who meet NCCN 2025 V1 high-risk criteria for invasive fungal disease, with expected neutropenia >7 days (absolute neutrophil count ≤0.5×10⁹/L), who have been initiated on liposomal amphotericin B prophylaxis at 50 mg/day by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
Hainan, Hainan, 570208
Xiaoyang Yang, MD, +86-13337647693, y108108@126.com
Luyi Pang, MMed, +86-15737306070, pangluyi2024@163.com
About this study
Official title: Evaluation of Low-Dose Liposomal Amphotericin B for Prophylaxis of Invasive Fungal Infections in Patients With Prolonged Neutropenia: A Clinical Study
This is a single-center, single-arm, observational clinical study evaluating the efficacy and safety of low-dose liposomal amphotericin B (50 mg/day, intravenous, once daily) for the prevention of invasive fungal infections in adult patients (aged 18-75 years) with hematological malignancies who develop prolonged neutropenia (absolute neutrophil count ≤0.5×10^9/L, expected to last >7 days) and are at high risk for invasive fungal disease. Participants are those who, per the treating physician's routine clinical decision, have been initiated on liposomal amphotericin B prophylaxis at 50 mg/day due to intolerance or toxicity to other antifungal agents. The primary outcome is the incidence of proven or probable invasive fungal disease. Secondary outcomes include incidence of pneumonia, persistent unexplained fever >4 days, use of additional systemic antifungal therapy, and adverse events. A total of 30 participants will be enrolled. Data will be collected at baseline, during treatment, and within 7 days after treatment completion.
Read the detailed description
Invasive fungal disease (IFD) is a serious and life-threatening infection caused by pathogenic fungi such as Candida, Aspergillus, and Mucorales, commonly affecting immunocompromised patients with hematological malignancies and those undergoing hematopoietic stem cell transplantation. The incidence of IFD has increased significantly in recent years due to the use of intensive chemotherapy and immunosuppressive agents, which result in prolonged and profound neutropenia (absolute neutrophil count <500/μL for ≥10 days). Effective antifungal prophylaxis is a critical strategy to reduce IFD-related morbidity and mortality in this high-risk population.
Liposomal amphotericin B (L-AmB) is a broad-spectrum antifungal agent with potent activity against most pathogenic fungi, including azole-resistant strains such as certain Aspergillus and Mucorales species. It is recommended by multiple guidelines as a first-line treatment for candidemia, invasive aspergillosis, and mucormycosis. However, its optimal prophylactic dosing regimen remains unclear, with published studies using widely varying regimens ranging from fixed low-dose (e.g., 50 mg every other day) to intermittent high-dose schedules (e.g., 5 mg/kg twice weekly).
This study proposes a prophylactic regimen of L-AmB at a fixed low dose of 50 mg/day administered intravenously once daily. This regimen is designed to provide sustained, continuous drug exposure throughout the high-risk neutropenic period, potentially offering superior protection compared to intermittent high-dose schedules while maintaining a favorable safety profile.
This is a single-center, single-arm, observational clinical study. Participants will be adults aged 18-75 years with hematological malignancies who meet the NCCN 2025 V1 guideline criteria for high-risk IFD, 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. Participants must have been initiated on L-AmB prophylaxis at 50 mg/day by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents. Key exclusion criteria include prior proven/probable IFD, active fungal infection at screening, significant hypokalemia, severe hepatic or renal impairment, NYHA Class III/IV heart failure, HIV/TPHA positivity, expected survival <3 months, and pregnancy or lactation.
A total of 30 participants will be enrolled. Data will be collected at three time points: baseline (Day -3 to 0), treatment period (from Day 1 until the end of L-AmB therapy), and follow-up (within 7 days after treatment completion). Assessments include complete blood counts, serum biochemistry, imaging (chest CT), microbiological tests (G/GM tests, blood cultures, bronchoalveolar lavage fluid cultures or NGS), and recording of neutropenia episodes, fever, pneumonia, and adverse events. IFD diagnosis will be classified according to the Sixth Revised Edition of the Diagnostic Criteria and Treatment Principles for Invasive Fungal Disease in Patients with Hematological Malignancies.
The primary outcome is the incidence of proven or probable IFD. Secondary outcomes include: (1) incidence of pneumonia with no identified pathogen; (2) proportion of patients with persistent unexplained fever >4 days; (3) proportion of patients requiring additional systemic antifungal therapy; (4) discontinuation rate due to adverse effects or intolerance; and (5) incidence of adverse events graded according to CTCAE Version 5.0.
The study is expected to enroll patients from August 2025 to August 2026, with final data analysis and report writing completed by November 2026. This study is approved by the institutional ethics committee and will be conducted in accordance with the Declaration of Helsinki. Informed consent will be obtained from all participants or their legal representatives.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia
- Being tested
- Liposomal Amphotericin B
- Keywords
- Liposomal Amphotericin B, Antifungal Prophylaxis, Invasive Fungal Disease, Prolonged Neutropenia, Hematological Malignancies
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Neutropenia, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Amphotericin BDrug
Also called L-AmB, Amphotericin B Liposome
Liposomal amphotericin B at 50 mg/day, administered intravenously once daily, for antifungal prophylaxis in patients with prolonged neutropenia. Liposomal amphotericin B is a broad-spectrum polyene antifungal agent with activity against most pathogenic fungi, including Candida, Aspergillus, and Mucorales species. The liposomal formulation reduces nephrotoxicity compared to conventional amphotericin B deoxycholate while maintaining equivalent antifungal activity.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Amphotericin B Prophylaxis Group | Adult patients with hematological malignancies who meet NCCN 2025 V1 high-risk criteria for invasive fungal disease, with expected neutropenia >7 days (absolute neutrophil count ≤0.5×10^9/L). Participants receive liposomal amphotericin B at 50 mg/day, intravenous, once daily, as antifungal prophylaxis initiated by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents. Receives: Drug: Liposomal Amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Proven or Probable Invasive Fungal Disease
Proven or probable invasive fungal disease (IFD) diagnosed according to the Sixth Revised Edition of the Diagnostic Criteria and Treatment Principles for Invasive Fungal Disease in Patients with Hematological Malignancies. Proven IFD requires histopathological evidence or positive culture from a sterile site. Probable IFD requires the presence of host factors, clinical features, and mycological evidence.
Measured: From baseline to 7 days after the end of antifungal prophylaxis treatment
Secondary outcomes (5)
Incidence of Pneumonia With No Identified Pathogen
Incidence of pneumonia occurring during the study period with no pathogen identified by microbiological or molecular methods, including but not limited to blood cultures, bronchoalveolar lavage fluid cultures, and NGS.
Measured: From baseline to 7 days after the end of antifungal prophylaxis treatment
Proportion of Participants With Persistent Unexplained Fever >4 Days
Proportion of participants with persistent unexplained fever lasting more than 4 days during the study period. Unexplained fever is defined as fever without an identifiable infectious source after initial clinical evaluation.
Measured: From baseline to 7 days after the end of antifungal prophylaxis treatment
Proportion of Participants Requiring Additional Systemic Antifungal Therapy
Proportion of participants who require systemic antifungal therapy other than the study drug (low-dose liposomal amphotericin B) for suspected or confirmed fungal infection during the study period.
Measured: From baseline to 7 days after the end of antifungal prophylaxis treatment
Discontinuation Rate Due to Adverse Effects or Intolerance
Proportion of participants who discontinue liposomal amphotericin B prophylaxis due to drug-related adverse effects or intolerance during the treatment period.
Measured: Throughout the treatment period (from Day 1 to the end of liposomal amphotericin B therapy)
Incidence of Adverse Events
Incidence of adverse events occurring during the study period, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Adverse events include laboratory abnormalities (serum creatinine elevation, hepatic enzyme elevation, hypokalemia) and clinical symptoms (infusion-related reactions, fever, chills, nausea, vomiting, etc.).
Measured: From baseline to 7 days after the end of antifungal prophylaxis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Aug 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xiaoyang, MD, Haikou Affiliated Hospital of Central South University Xiangya School of Medicine
- Investigators
- Xiaoyang Yang, Principal investigator, Department of Hematology, Haikou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763054
- Sponsor's protocol ID
- SC20250727
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center observational study with a small sample size of 30 adult participants. Individual participant data will not be shared because the research protocol did not include provisions for data sharing with external researchers. Furthermore, the study materials and records will be stored locally at the study site and will not be made publicly available to protect participant privacy, in accordance with the study's confidentiality and privacy protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-Dose Liposomal Amphotericin B for Prophylaxis of Invasive Fungal Infections in Patients With Prolonged Neutropenia: A Clinical Study
- ClinicalTrials.gov ID
- NCT07763054
- Acronym / sponsor ID
- SC20250727
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia
- Keywords
- Liposomal Amphotericin B, Antifungal Prophylaxis, Invasive Fungal Disease, Prolonged Neutropenia, Hematological Malignancies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Haikou Affiliated Hospital of Central South University Xiangya School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, single-arm, observational clinical study evaluating the efficacy and safety of low-dose liposomal amphotericin B (50 mg/day, intravenous, once daily) for the prevention of invasive fungal infections in adult patients (aged 18-75 years) with hematological malignancies who develop prolonged neutropenia (absolute neutrophil count ≤0.5×10^9/L, expected to last >7 days) and are at high risk for invasive fungal disease. Participants are those who, per the treating physician's routine clinical decision, have been initiated on liposomal amphotericin B prophylaxis at 50 mg/day due to intolerance or toxicity to other antifungal agents. The primary outcome is the incidence of proven or probable invasive fungal disease. Secondary outcomes include incidence of pneumonia, persistent unexplained fever >4 days, use of additional systemic antifungal therapy, and adverse events. A total of 30 participants will be enrolled. Data will be collected at baseline, during treatment, and within 7 days after treatment completion.
Detailed description
Invasive fungal disease (IFD) is a serious and life-threatening infection caused by pathogenic fungi such as Candida, Aspergillus, and Mucorales, commonly affecting immunocompromised patients with hematological malignancies and those undergoing hematopoietic stem cell transplantation. The incidence of IFD has increased significantly in recent years due to the use of intensive chemotherapy and immunosuppressive agents, which result in prolonged and profound neutropenia (absolute neutrophil count <500/μL for ≥10 days). Effective antifungal prophylaxis is a critical strategy to reduce IFD-related morbidity and mortality in this high-risk population.
Liposomal amphotericin B (L-AmB) is a broad-spectrum antifungal agent with potent activity against most pathogenic fungi, including azole-resistant strains such as certain Aspergillus and Mucorales species. It is recommended by multiple guidelines as a first-line treatment for candidemia, invasive aspergillosis, and mucormycosis. However, its optimal prophylactic dosing regimen remains unclear, with published studies using widely varying regimens ranging from fixed low-dose (e.g., 50 mg every other day) to intermittent high-dose schedules (e.g., 5 mg/kg twice weekly).
This study proposes a prophylactic regimen of L-AmB at a fixed low dose of 50 mg/day administered intravenously once daily. This regimen is designed to provide sustained, continuous drug exposure throughout the high-risk neutropenic period, potentially offering superior protection compared to intermittent high-dose schedules while maintaining a favorable safety profile.
This is a single-center, single-arm, observational clinical study. Participants will be adults aged 18-75 years with hematological malignancies who meet the NCCN 2025 V1 guideline criteria for high-risk IFD, 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. Participants must have been initiated on L-AmB prophylaxis at 50 mg/day by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents. Key exclusion criteria include prior proven/probable IFD, active fungal infection at screening, significant hypokalemia, severe hepatic or renal impairment, NYHA Class III/IV heart failure, HIV/TPHA positivity, expected survival <3 months, and pregnancy or lactation.
A total of 30 participants will be enrolled. Data will be collected at three time points: baseline (Day -3 to 0), treatment period (from Day 1 until the end of L-AmB therapy), and follow-up (within 7 days after treatment completion). Assessments include complete blood counts, serum biochemistry, imaging (chest CT), microbiological tests (G/GM tests, blood cultures, bronchoalveolar lavage fluid cultures or NGS), and recording of neutropenia episodes, fever, pneumonia, and adverse events. IFD diagnosis will be classified according to the Sixth Revised Edition of the Diagnostic Criteria and Treatment Principles for Invasive Fungal Disease in Patients with Hematological Malignancies.
The primary outcome is the incidence of proven or probable IFD. Secondary outcomes include: (1) incidence of pneumonia with no identified pathogen; (2) proportion of patients with persistent unexplained fever >4 days; (3) proportion of patients requiring additional systemic antifungal therapy; (4) discontinuation rate due to adverse effects or intolerance; and (5) incidence of adverse events graded according to CTCAE Version 5.0.
The study is expected to enroll patients from August 2025 to August 2026, with final data analysis and report writing completed by November 2026. This study is approved by the institutional ethics committee and will be conducted in accordance with the Declaration of Helsinki. Informed consent will be obtained from all participants or their legal representatives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposomal Amphotericin B Prophylaxis Group | – | Drug: Liposomal Amphotericin BAdult patients with hematological malignancies who meet NCCN 2025 V1 high-risk criteria for invasive fungal disease, with expected neutropenia >7 days (absolute neutrophil count ≤0.5×10^9/L). Participants receive liposomal amphotericin B at 50 mg/day, intravenous, once daily, as antifungal prophylaxis initiated by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged 18-75 years) with hematological malignancies who meet NCCN 2025 V1 high-risk criteria for invasive fungal disease, with expected neutropenia >7 days (absolute neutrophil count ≤0.5×10⁹/L), who have been initiated on liposomal amphotericin B prophylaxis at 50 mg/day by the treating physician in routine clinical practice due to intolerance or toxicity to other antifungal agents.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal Amphotericin BAlso: L-AmB, Amphotericin B LiposomeLiposomal amphotericin B at 50 mg/day, administered intravenously once daily, for antifungal prophylaxis in patients with prolonged neutropenia. Liposomal amphotericin B is a broad-spectrum polyene antifungal agent with activity against most pathogenic fungi, including Candida, Aspergillus, and Mucorales species. The liposomal formulation reduces nephrotoxicity compared to conventional amphotericin B deoxycholate while maintaining equivalent antifungal activity. | Drug | Liposomal Amphotericin B Prophylaxis Group |
Primary outcome
Incidence of Proven or Probable Invasive Fungal Disease
Time frame: From baseline to 7 days after the end of antifungal prophylaxis treatment
Proven or probable invasive fungal disease (IFD) diagnosed according to the Sixth Revised Edition of the Diagnostic Criteria and Treatment Principles for Invasive Fungal Disease in Patients with Hematological Malignancies. Proven IFD requires histopathological evidence or positive culture from a sterile site. Probable IFD requires the presence of host factors, clinical features, and mycological evidence.
5 secondary outcomes
Incidence of Pneumonia With No Identified Pathogen
Time frame: From baseline to 7 days after the end of antifungal prophylaxis treatment
Proportion of Participants With Persistent Unexplained Fever >4 Days
Time frame: From baseline to 7 days after the end of antifungal prophylaxis treatment
Proportion of Participants Requiring Additional Systemic Antifungal Therapy
Time frame: From baseline to 7 days after the end of antifungal prophylaxis treatment
Discontinuation Rate Due to Adverse Effects or Intolerance
Time frame: Throughout the treatment period (from Day 1 to the end of liposomal amphotericin B therapy)
Incidence of Adverse Events
Time frame: From baseline to 7 days after the end of antifungal prophylaxis treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. This is a single-center observational study with a small sample size of 30 adult participants. Individual participant data will not be shared because the research protocol did not include provisions for data sharing with external researchers. Furthermore, the study materials and records will be stored locally at the study site and will not be made publicly available to protect participant privacy, in accordance with the study's confidentiality and privacy protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyang Yang principal investigator
Department of Hematology, Haikou People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Haikou Affiliated Hospital of Central South University Xiangya School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyang Yang, MD (+86-13337647693, y108108@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Proven or Probable Invasive Fungal Disease (time frame: From baseline to 7 days after the end of antifungal prophylaxis treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.