Prophylaxis of Febrile Neutropenia With Lactoferrin in Oncohematologic Children Undergoing Induction Chemotherapy

Test, in a randomized phase II trial, the safety and efficacy of lactoferrin prophylaxis in preventing the occurrence of febrile neutropenia and sepsis, with particular regard to forms due to multidrug-resistant Gram-negative bacteria.

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Key information

Conditions

Febrile Neutropenia (FN) Agranulocytosis Chemotherapy Treatment Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Infections Inflammation Leukocyte Disorders Leukopenia Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo Pavia

Pavia, Italy, 27100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with severe neutropenia lasting >7 days:

non-High Risk Acute Lymphoblastic Leukemia ( ALL) under induction treatment
Acute Myeloid Leukemia (AML) (first two cycles of treatment)
B cell - non Hodgkin Lymphoma (NHL) Ability to take oral lactoferrin therapy and perform the diagnostic tests established by the protocol

Exclusion criteria

Previous chemotherapy treatments
Past history of colonization/infection by multidrug-resistant pathogens
Inability to take LF by mouth
Refusal to participate in the study

Treatment and study plan

Lactoferrin Bovine

Dietary Supplement

In addition to standard treatment, a gold-soluble formulation of bovine lactoferrin or bLF (Mosiac®) at the standard dose of 200 mg/day, in single administration, from the start of chemo/radiotherapy treatment and throughout the risk period.

Primary outcomes

Primary Outcome

Time frame: From treatment up to 90 days

Presence or absence of febrile neutropenia or sepsis

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Phase II Study for Prophylaxis of Febrile Neutropenia by Supplementation With Lactoferrin in Oncohematologic Children Undergoing High-intensity Chemotherapy Treatment

Acronym: Lactoferrin

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2022
First posted: Aug 8, 2025
Registry last updated: Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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