Liposomal amphotericin B (AmBisome) for breakthrough invasive fungal infections in children and teens with 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-center, prospective, single-arm observational study enrolling children and adolescents (1 month to 18 years) with hematological malignancies who develop breakthrough invasive fungal disease while on triazole or echinocandin prophylaxis. Enrolled patients receive liposomal amphotericin B (AmBisome) as part of routine care and investigators will record clinical response and safety outcomes, including renal function, using EORTC/MSG 2020 definitions for proven, probable, and possible IFD. The planned sample size is 43 (allowing for 10% dropout) to estimate a presumed 67% favorable response rate with a 95% confidence interval. Data will be compared to historical adult benchmarks and baseline characteristics that predict response will be explored.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The children and adolescent patients with hematological malignancy received echinocandin/triazole for antifungal prophylaxis and diagnosed with br-IFD.

  1. Age: from 1 month to 18 years old.
  2. Diagnosed patients with hematological malignancy.
  3. Received echinocandin/triazole for antifungal prophylaxis at least 7 days.
  4. Br-IFD is defined as a proven, probable, and possible IFD diagnosed at least 7 days after the start of primary antifungal prophylaxis and by 7 days from the end of primary antifungal prophylaxis. Definitions of proven, probable and possible IFD based on the EORTC/MSG 2020 criteria.
  5. ECOG-PS(Eastern Cooperative Oncology Group Performance Status): 0-2 points.
  6. There are no organ dysfunction restrictions during the screening period that limit the use of this protocol.
  7. The guardian understands the research and signs written informed consent form.

Exclusion Criteria:

* (a) Received AmB formulation for prophylaxis or treatment within the past 30 days.

  (b) Confirmed allergy/rapid onset severe allergic reaction/intolerance to L-AmB (c) Has a history of other tumors and has received any treatment for this tumor within the past 3 years (d) HIV, active hepatitis B and active hepatitis C virus or syphilis infection (e) Suffering from mental illness or other conditions that prevent cooperation with research, treatment, and monitoring requirements (f) Serum creatinine level 2 times the upper limit of normal; Liver transaminase or alkaline phosphatase levels 5 times the upper limit of normal, bilirubin levels 3 times the upper limit of normal (g) Researchers believe that patients who are not suitable for inclusion

Where it's running

• National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Wenyu Yang, Doctor
• Email: yangwenyu@ihcams.ac.cn
• Phone: +86 13821596186

Similar studies

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

• FUNGAL-P: A score to spot fungal pneumonia early in adults with pneumonia

  Aimed at adults with pneumonia, this study tests a new score to help identify fungal pneumonia sooner so doctors can test appropriately and start antifungal treatment when needed.

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• Tracking invasive fungal infections after allogeneic hematopoietic stem cell transplant

  We will follow people who had an allogeneic stem cell transplant to see how often serious fungal infections occur and which clinical factors predict them.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07569055

• Treating breakthrough invasive fungal infections in blood cancer patients with liposomal amphotericin B versus isavuconazole/posaconazole

  This project will test whether liposomal amphotericin B or isavuconazole/posaconazole works better and is safer for adults with blood cancers who develop breakthrough invasive fungal infections after antifungal prophylaxis.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07135778

• Evaluating the effectiveness of amphotericin B and azoles for invasive fungal infections

  This study looks at how well amphotericin B and azole antifungals work and how safe they are for patients with invasive fungal infections based on their medical records.

  Recruiting Sichuan Provincial People's Hospital · Chengdu, Sichuan · NCT06819410

• Immune monitoring during invasive mold infections.

  This project will test whether tracking T-cell immune checkpoints can identify adults with invasive mold infections who might benefit from adding immunotherapy to antifungal treatment.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT06285188

• Global registry for emerging invasive fungal infections

  This study is collecting information about invasive fungal infections to better understand how they spread, how they are diagnosed, and how well different treatments work for people affected by them.

  Recruiting University of Cologne · Cologne, North Rhine-Westphalia · NCT01731353

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.