Acute Lymphoblastic LeukemiaALL-IFINCT06392581
Observational Study on Invasive Fungal Infection Incidence in Ph-neg Acute Lymphoblastic Leukemia Patients
An observational study of Acute Lymphoblastic Leukemia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives To document the occurrence of IFI in relation to antifungal prophylaxis adopted To document the occurrence of IFI in relation to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2022to 30 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by Ph-pos ALL
Who may be able to join
- Patients with B Ph-neg or T ALL at onset
- Age > 18 yr at the time of the study
- Signature informed consent
Who cannot join
- Patients with Ph-pos ALL
- Patients with relapsing ALL
- Patients with B/T lymphoblastic lymphoma
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
chiara cattaneo, md, 03039951, chiara.cattaneo@asst-spedalicivili.it
aldo roccaro, md, 03039951, coordinamento.ricerca@asst-spedalicivili.it
About this study
Official title: Prospective Observational Study on the Incidence of Invasive Fungal Infections in Patients With Ph-negative Acute Lymphoblastic Leukemia
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives
- To document the occurrence of IFI in relation to antifungal prophylaxis adopted
- To document the occurrence of IFI in relation to the age of the patients
- Document the occurrence of IFI in relation to the duration of neutropenia
- Document the occurrence of IFI in relation to the type of steroid treatment adopted (dexamethasone yes vs no)
- Document any delays in the initiation of consolidation chemotherapy in LLA patients with IFI
- Document the outcome of patients with ALL with IFI
Read more
Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.
The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:
- Age
- Sex
- Type of AF prophylaxis performed
- LLA risk classification according to ESMO 2016 criteria
- Dose of dexamethasone administered
- Duration of neutropenia
- Hematologic and molecular response
Read the detailed description
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives
- To document the occurrence of IFI in relation to antifungal prophylaxis adopted
- To document the occurrence of IFI in relation to the age of the patients
- Document the occurrence of IFI in relation to the duration of neutropenia
- Document the occurrence of IFI in relation to the type of steroid treatment adopted (dexamethasone yes vs no)
- Document any delays in the initiation of consolidation chemotherapy in LLA patients with IFI
- Document the outcome of patients with ALL with IFI
Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.
The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:
- Age
- Sex
- Type of AF prophylaxis performed
- LLA risk classification according to ESMO 2016 criteria
- Dose of dexamethasone administered
- Duration of neutropenia
- Hematologic and molecular response
Inclusion criteria
- Patients with ALL B Ph-neg or T at onset
- Age > 18 yr at the time of the study
- Signature informed consent Exclusion criteria
- Patients with Ph-pos ALL
- Patients with relapsing ALL
- Patients with B/T lymphoblastic lymphoma Primary endpoint
- Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients.
Secondary endpoints
- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted
- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
- Patient mortality rate in Ph-neg ALL patients with IFI Study Duration All eligible patients will be enrolled from 01.03.2022 for a duration of 18 months. The follow-up time after enrollment will be 12 months.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- invasive fungal infections; acute lymphoblastic leukemia; outcome
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Invasive Fungal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
Measured: 16 weeks
Secondary outcomes (6)
- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted
- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted
Measured: 16 weeks
- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
Measured: 16 weeks
- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
Measured: 16 weeks
- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
Measured: 16 weeks
- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
Measured: 16 weeks
Patient mortality rate in Ph-neg ALL patients with IFI
Patient mortality rate in Ph-neg ALL patients with IFI
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start14 Apr 2022
- Primary completion12 Mar 2024
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Cattaneo, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- chiara cattaneo, md, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392581
- Sponsor's protocol ID
- SEIFEM ALL-IFI 2022_NP 5250
- Acronym
- ALL-IFI
- Status last verified
- Aug 2024
- First submitted
- 1 Mar 2024
- Last updated
- 6 Aug 2024
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Incidence of Invasive Fungal Infections in Patients With Ph-negative Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06392581
- Acronym / sponsor ID
- ALL-IFI / SEIFEM ALL-IFI 2022_NP 5250
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- invasive fungal infections; acute lymphoblastic leukemia; outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives
- To document the occurrence of IFI in relation to antifungal prophylaxis adopted
- To document the occurrence of IFI in relation to the age of the patients
- Document the occurrence of IFI in relation to the duration of neutropenia
- Document the occurrence of IFI in relation to the type of steroid treatment adopted (dexamethasone yes vs no)
- Document any delays in the initiation of consolidation chemotherapy in LLA patients with IFI
- Document the outcome of patients with ALL with IFI
Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.
The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:
- Age
- Sex
- Type of AF prophylaxis performed
- LLA risk classification according to ESMO 2016 criteria
- Dose of dexamethasone administered
- Duration of neutropenia
- Hematologic and molecular response
Detailed description
Primary objective To document the occurrence of fungal infections during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in adult Ph-neg ALL patients Secondary objectives
- To document the occurrence of IFI in relation to antifungal prophylaxis adopted
- To document the occurrence of IFI in relation to the age of the patients
- Document the occurrence of IFI in relation to the duration of neutropenia
- Document the occurrence of IFI in relation to the type of steroid treatment adopted (dexamethasone yes vs no)
- Document any delays in the initiation of consolidation chemotherapy in LLA patients with IFI
- Document the outcome of patients with ALL with IFI
Study design The study is prospective and observational, multicenter, real-life study involving 26 centers afferent to the SEIFEM group. All Ph-neg ALL patients aged 18 years or older treated with intensive chemotherapy starting from 01.06.22 for the duration of 18 months (+12 months follow-up) will be enrolled. The diagnosis of IFI will be defined according to EORTC 2019 criteria. Clinical information will be collected in paper CRFs, compiled anonymously.
The incidence of IFI and pulmonary aspergillosis during induction chemotherapy will be related to the following variables:
- Age
- Sex
- Type of AF prophylaxis performed
- LLA risk classification according to ESMO 2016 criteria
- Dose of dexamethasone administered
- Duration of neutropenia
- Hematologic and molecular response
Inclusion criteria
- Patients with ALL B Ph-neg or T at onset
- Age > 18 yr at the time of the study
- Signature informed consent Exclusion criteria
- Patients with Ph-pos ALL
- Patients with relapsing ALL
- Patients with B/T lymphoblastic lymphoma Primary endpoint
- Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients.
Secondary endpoints
- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted
- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
- Patient mortality rate in Ph-neg ALL patients with IFI Study Duration All eligible patients will be enrolled from 01.03.2022 for a duration of 18 months. The follow-up time after enrollment will be 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by Ph-pos ALL
Key inclusion criteria (3 listed)
- Patients with B Ph-neg or T ALL at onset
- Age > 18 yr at the time of the study
- Signature informed consent
Key exclusion criteria (3 listed)
- Patients with Ph-pos ALL
- Patients with relapsing ALL
- Patients with B/T lymphoblastic lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
Time frame: 16 weeks
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients
6 secondary outcomes
- Incidence of IFI in Ph-neg ALL patients during induction in relation to antifungal prophylaxis adopted
Time frame: 16 weeks
- Incidence of IFI in patients with Ph-neg ALL during induction in relation to age
Time frame: 16 weeks
- Incidence of IFI in Ph-neg ALL patients during induction in relation to duration of neutropenia
Time frame: 16 weeks
- Incidence of IFI in Ph-neg ALL patients in relation to type of steroid treatment adopted (dexamethasone yes vs no)
Time frame: 16 weeks
- Median time elapsed between actual start of consolidation chemotherapy versus schedule in Ph-neg ALL patients with IFI
Time frame: 16 weeks
Patient mortality rate in Ph-neg ALL patients with IFI
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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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.
chiara cattaneo, md principal investigator
Asst Degli Spedali Civili Di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chiara cattaneo, md (03039951, chiara.cattaneo@asst-spedalicivili.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of IFI during the early stages of chemotherapy (from onset to TP2, i.e., week 16) in Ph-neg ALL patients (time frame: 16 weeks). 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 6 Aug 2024.