Study Protocol: Study on Incidence and Risk Factors of Mold Infections in Children During Leukemia Treatment

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Incidence and Risk Factors for Invasive Mold Infections in Children During First-Line Chemotherapy for Primary Acute Leukemia: Protocol for a National Retrospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05774990
• Other study ID #: 22/15850
• Status: Active, not recruiting
• Start date: April 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to evaluate the occurrence, mortality, and risk factors for invasive mold infections (IMI) in children treated with chemotherapy for acute leukemia in Denmark. The study will be a retrospective nationwide survey study of all children who received first-line chemotherapy for acute leukemia from 2008 to 2022 in Danish pediatric oncology units. The study population will include approximately 800 children under the age of 18. Data will be collected from medical records, hospital databases, and national databases. When the IMI subgroup has been identified, this will be compared to the leukemic group that did not develop IMI. Statistical analysis can then determine the occurrence, mortality rate, and possible IMI risk factors.

Description:

Chemotherapy can weaken children's immune system, making them vulnerable to infections, including invasive mold infections (IMI), caused mainly by Aspergillus spp. The at-risk population for IMI in children with acquired immunodeficiency is patients with prolonged granulocytopenia due to hematologic malignancies treated with chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) recipients and children receiving long-term corticosteroid treatment. Incidences and mortality rates are often reported as high.

In a retrospective cohort study, we aim to obtain an epidemiological overview of IMI in children receiving first-line treatment for acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) in Denmark from 2008 to 2022 and identify possible risk factors, including treatment-related adverse effects.

Objectives

1. To determine and compare the incidence of IMI in childhood AML and ALL during first-line chemotherapy in Denmark.

2. To determine and compare the mortality of IMI in childhood AML and ALL during first-line chemotherapy in Denmark.

3. To explore risk factors for IMI in childhood AML and ALL during first-line chemotherapy in Denmark.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: August 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Age <18 years at the time of inclusion

• Received first-line treatment for ALL or AML

• Treatment at a Danish tertiary pediatric oncology unit (Rigshospitalet, Aarhus University Hospital, Odense University Hospital, and Aalborg University Hospital)

• Treatment initiation January 1st, 2008, to December 31st, 2022

Exclusion Criteria:

• Not meeting inclusion criteria

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Denmark	Rasmus Møller Duus	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense Patient Data Explorative Network, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of invasive mold infection in childhood AML and ALL in Denmark	The number of subjects in the cohort infected with an invasive mold during leukemia treatment period as defined by the European Organization for Research and Treatment of Cancer Mycoses study group (EORTC/MSG) criteria	Up to three years
Primary	Mortality form invasive mold infection in childhood AML and ALL in Denmark.	The number of subjects in the cohort dying from an invasive mold infection during their leukemia treatment period	Up to three years