Mucormycosis in Hematologic MalignanciesNCT07185503
Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety
An observational study of Mucormycosis in Hematologic Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China at 9 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mucormycosis in Hematologic Malignancies
- What is being tested?
- liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 60 participants
- Where
- 9 sitesChina
- Study dates
- 25 Mar 2025to Jan 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mucormycosis in Hematologic Malignancies patients
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
The Second Hospital of Dalian Medical University
Dalian
Jinsong Yan, +86155 4117 8715, yanjsdmu@dmu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin
Shengjin Fan, +8613304641978, fansjhmu@163.com
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang
Aijun Liao, +8618940259833, liaoaijun@sina.com
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shenyang
Xiaojing Yan, +8613889128302, yanxiaojing_pp@hotmail.com
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, 300020
Mingfeng Zhao, +8613752640369, mingfengzhao@sina.com
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin
Sizhou Feng, szfeng@ihcams.ac.cn
- Not yet recruiting
Second Hospital of Tianjin Medical University
Tianjin
Jie Bai, +86189 0206 6758, janebai86@tmu.edu.cn
- Not yet recruiting
Tianjin Haihe Hospital
Tianjin
Naibo Hu, +86139 2017 8129
- Not yet recruiting
Tianjin Union Medical Center of Nankai University
Tianjin
Xingli Zhao, +86137 5225 5454, insectzhao@163.com
About this study
Official title: 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 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.
Read the detailed description
This research aims to test whether combining two antifungal medications-liposomal amphotericin B (given through an IV) and either posaconazole or isavuconazole (available as IV or oral pills)-can effectively and safely treat adults with blood cancers (like leukemia or lymphoma) who develop a severe fungal infection called mucormycosis. Current guidelines often recommend amphotericin B-based therapies, but optimal dosing, combinations, and treatment duration remain unclear. This study will provide critical data on whether a regimen of liposomal amphotericin B (3-5 mg/kg/day) paired with newer antifungals (posaconazole/isavuconazole) can enhance outcomes. It will also identify which patient characteristics (e.g., age, cancer type, recovery speed) most strongly affect survival, helping doctors personalize care.
- Conditions
- Mucormycosis in Hematologic Malignancies
- Being tested
- liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole
- Keywords
- Mucormycosis, Hematologic Malignancies, Liposomal Amphotericin B, posaconazole or isavuconazole
- Medical subject headings
- Mucormycosis, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazoleDrug
The intervention in this study is a tailored antifungal regimen combining liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) with posaconazole or isavuconazole (300 mg/200 mg daily, oral or IV), designed to optimize efficacy and safety in immunocompromised adults with blood cancers and mucormycosis. Dosing and duration are personalized based on clinical response, immune recovery, and organ function, with a focus on transitioning to oral therapy to reduce hospitalization. The study emphasizes rigorous safety monitoring, prohibited unauthorized antifungal co-medications, and explores prognostic factors to advance treatment strategies for this high-risk population.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm,multi-center real-world study | This is a single-arm study where all participants receive the same treatment. Participants will be treated with a combination antifungal regimen comprising:
1. Liposomal Amphotericin B (L-AmB):
Dose: 3-5 mg/kg/day administered intravenously (IV). Duration: Daily infusions until clinical stability, with adjustments permitted based on disease severity and tolerability.
2. Posaconazole or Isavuconazole:
Formulations: Oral tablets or intravenous (IV) formulations. Dosing: Loading dose: As per product labeling. Maintenance dose: 300 mg (posaconazole) or 200 mg (isavuconazole) once daily. Duration: Continued orally after discontinuation of L-AmB, per clinical judgment. Receives: Drug: liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Response Rate at End of liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) Therapy
The proportion of participants achieving a composite response, defined as the complete or partial resolution of mucormycosis-related clinical symptoms, radiological improvement (e.g., reduction in lesion size on CT/MRI), and microbiological clearance (e.g., negative fungal cultures or biomarkers).
Measured: Assessed immediately after discontinuation of liposomal amphotericin B therapy.
Secondary outcomes (4)
Survival Rate at Key Time Points
Proportion of participants alive at (1) end of liposomal amphotericin B (L-AmB) therapy, (2) 42 days post-therapy, and (3) 84 days post-therapy. Survival is defined as being free from death due to any cause.
Measured: Day 84
Time to Favorable Overall Response
Duration from study enrollment to achievement of a favorable overall response (complete or partial resolution of mucormycosis symptoms, radiological improvement, and microbiological clearance).
Measured: From date of enrollment until the date of first documented response, assessed up to 84 dsys.
Length of Hospitalization
Total number of days participants spend hospitalized from enrollment until discharge or death.
Measured: Measured immediately after the intervention
Safety and Tolerability Profile
Incidence and severity of treatment-emergent adverse events (TEAEs), including nephrotoxicity, hepatotoxicity, infusion reactions, and electrolyte abnormalities, graded per CTCAE v5.0 criteria.
Measured: Measured immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start25 Mar 2025
- Primary completionJun 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucormycosis in Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sizhou Feng, Study director, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185503
- Sponsor's protocol ID
- QTJC2025004
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07185503
- Acronym / sponsor ID
- QTJC2025004
- Conditions
- Mucormycosis in Hematologic Malignancies
- Keywords
- Mucormycosis, Hematologic Malignancies, Liposomal Amphotericin B, posaconazole or isavuconazole
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Sep 2025 (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 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.
Detailed description
This research aims to test whether combining two antifungal medications-liposomal amphotericin B (given through an IV) and either posaconazole or isavuconazole (available as IV or oral pills)-can effectively and safely treat adults with blood cancers (like leukemia or lymphoma) who develop a severe fungal infection called mucormycosis. Current guidelines often recommend amphotericin B-based therapies, but optimal dosing, combinations, and treatment duration remain unclear. This study will provide critical data on whether a regimen of liposomal amphotericin B (3-5 mg/kg/day) paired with newer antifungals (posaconazole/isavuconazole) can enhance outcomes. It will also identify which patient characteristics (e.g., age, cancer type, recovery speed) most strongly affect survival, helping doctors personalize care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm,multi-center real-world study | – | Drug: liposomal amphotericin B (3-5 mg/kg/day) combined with posaconazole/isavuconazoleThis is a single-arm study where all participants receive the same treatment. Participants will be treated with a combination antifungal regimen comprising: 1. Liposomal Amphotericin B (L-AmB): Dose: 3-5 mg/kg/day administered intravenously (IV). Duration: Daily infusions until clinical stability, with adjustments permitted based on disease severity and tolerability. 2. Posaconazole or Isavuconazole: Formulations: Oral tablets or intravenous (IV) formulations. Dosing: Loading dose: As per product labeling. Maintenance dose: 300 mg (posaconazole) or 200 mg (isavuconazole) once daily. Duration: Continued orally after discontinuation of L-AmB, per clinical judgment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mucormycosis in Hematologic Malignancies patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 B (3-5 mg/kg/day) combined with posaconazole/isavuconazoleThe intervention in this study is a tailored antifungal regimen combining liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) with posaconazole or isavuconazole (300 mg/200 mg daily, oral or IV), designed to optimize efficacy and safety in immunocompromised adults with blood cancers and mucormycosis. Dosing and duration are personalized based on clinical response, immune recovery, and organ function, with a focus on transitioning to oral therapy to reduce hospitalization. The study emphasizes rigorous safety monitoring, prohibited unauthorized antifungal co-medications, and explores prognostic factors to advance treatment strategies for this high-risk population. | Drug | Single-arm,multi-center real-world study |
Primary outcome
Composite Response Rate at End of liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) Therapy
Time frame: Assessed immediately after discontinuation of liposomal amphotericin B therapy.
The proportion of participants achieving a composite response, defined as the complete or partial resolution of mucormycosis-related clinical symptoms, radiological improvement (e.g., reduction in lesion size on CT/MRI), and microbiological clearance (e.g., negative fungal cultures or biomarkers).
4 secondary outcomes
Survival Rate at Key Time Points
Time frame: Day 84
Time to Favorable Overall Response
Time frame: From date of enrollment until the date of first documented response, assessed up to 84 dsys.
Length of Hospitalization
Time frame: Measured immediately after the intervention
Safety and Tolerability Profile
Time frame: Measured immediately after the intervention
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 22 Sep 2025.
- Individual participant dataSharing planned: No
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.
Sizhou Feng study director
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucormycosis in Hematologic Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China at 9 sites 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 6 inclusion and 10 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Sizhou Feng, professor (+8618322098556, szfeng@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Response Rate at End of liposomal amphotericin B (L-AmB) (3-5 mg/kg/day IV) Therapy (time frame: Assessed immediately after discontinuation of liposomal amphotericin B therapy.). 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 22 Sep 2025.