Febrile Neutropenia (FN)LactoferrinNCT07113314
Prophylaxis of Febrile Neutropenia With Lactoferrin in Oncohematologic Children Undergoing Induction Chemotherapy
A study testing Lactoferrin Bovine in people with Febrile Neutropenia (FN) and Sepsis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Febrile Neutropenia (FN), Sepsis, Chemotherapy Treatment
- What is being tested?
- Lactoferrin Bovine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 6 Oct 2016to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Previous chemotherapy treatments
- Past history of colonization/infection by multidrug-resistant pathogens
- Inability to take LF by mouth
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study for Prophylaxis of Febrile Neutropenia by Supplementation With Lactoferrin in Oncohematologic Children Undergoing High-intensity Chemotherapy Treatment
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.
- Conditions
- Febrile Neutropenia (FN), Sepsis, Chemotherapy Treatment
- Being tested
- Lactoferrin Bovine
- Keywords
- chemotherapy treatment, Sepsis, Febbrile neutropenia
- Medical subject headings
- Febrile Neutropenia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin BovineDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin | Experimental | Patients in the prophylaxis group will receive, in addition to standard treatment, a orodispersible formulation of bovine lactoferrin or bLF (Mosiac®) at the standard dose of 200 mg/day, in single administration, from the start of chemotherapy treatment and for the duration of the risk period. Receives: Dietary Supplement: Lactoferrin Bovine |
| Placebo | Placebo comparator | Patients in the control group will receive only the standard treatment provided by their clinical center with placebo added from the start of chemo/radiotherapy treatment and throughout the duration of the risk period. Receives: Dietary Supplement: Lactoferrin Bovine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Presence or absence of febrile neutropenia or sepsis
Measured: From treatment up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start6 Oct 2016
- Primary completion3 Mar 2018
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile Neutropenia (FN)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Zecca, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113314
- Sponsor's protocol ID
- Lactoferrin 3527/2016
- Acronym
- Lactoferrin
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for Prophylaxis of Febrile Neutropenia by Supplementation With Lactoferrin in Oncohematologic Children Undergoing High-intensity Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT07113314
- Acronym / sponsor ID
- Lactoferrin / Lactoferrin 3527/2016
- Conditions
- Febrile Neutropenia (FN), Sepsis, Chemotherapy Treatment
- Keywords
- chemotherapy treatment, Sepsis, Febbrile neutropenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 8 Aug 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin | Experimental | Dietary Supplement: Lactoferrin BovinePatients in the prophylaxis group will receive, in addition to standard treatment, a orodispersible formulation of bovine lactoferrin or bLF (Mosiac®) at the standard dose of 200 mg/day, in single administration, from the start of chemotherapy treatment and for the duration of the risk period. |
| Placebo | Placebo comparator | Dietary Supplement: Lactoferrin BovinePatients in the control group will receive only the standard treatment provided by their clinical center with placebo added from the start of chemo/radiotherapy treatment and throughout the duration of the risk period. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Previous chemotherapy treatments
- Past history of colonization/infection by multidrug-resistant pathogens
- Inability to take LF by mouth
- Refusal to participate in the study
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 |
|---|---|---|
| Lactoferrin BovineIn 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. | Dietary supplement | Lactoferrin, Placebo |
Primary outcome
Primary Outcome
Time frame: From treatment up to 90 days
Presence or absence of febrile neutropenia or sepsis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Related trials for Febrile Neutropenia (FN)
Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
Recruiting
Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients
Bloodstream Infection, Gram Negative Infections
Enrolling by invitationObservational study
Study on the Efficacy and Safety of Different Doses of PEG-rhG-CSF for Primary Prevention of Febrile Neutropenia
Malignant Tumor
Not yet recruitingObservational study
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
Breast Cancer, Chemotherapy-Induced Neutropenia
RecruitingPhase 2
Phase II Study of QLC2519 in Pediatric Solid Tumor Participants
Pediatric Malignant Solid Tumor, Febrile Neutropenia (FN)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin Bovine in people with Febrile Neutropenia (FN) and Sepsis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Aug 2025. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: From treatment up to 90 days). 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 8 Aug 2025.