Invasive AspergillosisNCT06382922
Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy
An observational study of Invasive Aspergillosis, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Invasive Aspergillosis
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2023to 1 Jun 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 60 to 80 years
- All sexes
- Adult, Older adult
Study population: Considering our previous results and that in the subset of patients older than 60 years patients, who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%), we calculated that sample side should be 300 patients for arms. This sample size achieves 90% power to detect a difference of 10% .
Who may be able to join
- Signed written informed consent according to ICH/EU/GCP and national/local laws
- Patients aged older than 60 years underwent to consolidation course with intermediate/high doses of cytarabine
Who cannot join
- Diagnosis of IA during induction course and previous antifungal treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Tor Vergata University
Roma, RM, 00133
Maria Ilaria Del Principe, 3394080659, del.principe@med.uniroma2.it
About this study
Official title: Prospective, Observational Study of the Role of Primary Antifungal Prophylaxis to Prevent Invasive Aspergillosis in Elderly Patients With Acute Myeloid Leukemia Undergoing Consolidation Therapy
In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA [43 probable (1.7%) and 13 proven (0.5%)]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC).
The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course.
In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP.
Read the detailed description
Evaluate the protective role of mold active PAP in patients older than 60 years underwent to chemotherapy of consolidation with intermediate or high doses of cytarabine
- Conditions
- Invasive Aspergillosis
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients
rate of IA
Measured: 60 months
Secondary outcomes (1)
overall mortality rate
rate
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start29 Mar 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Ilaria Del Principe, University of Rome Tor Vergata
- Investigators
- Maria Ilaria Del Principe, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382922
- Sponsor's protocol ID
- PAPAML022019
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study of the Role of Primary Antifungal Prophylaxis to Prevent Invasive Aspergillosis in Elderly Patients With Acute Myeloid Leukemia Undergoing Consolidation Therapy
- ClinicalTrials.gov ID
- NCT06382922
- Acronym / sponsor ID
- PAPAML022019
- Conditions
- Invasive Aspergillosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 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.
In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA [43 probable (1.7%) and 13 proven (0.5%)]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC).
The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course.
In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP.
Detailed description
Evaluate the protective role of mold active PAP in patients older than 60 years underwent to chemotherapy of consolidation with intermediate or high doses of cytarabine
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Considering our previous results and that in the subset of patients older than 60 years patients, who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%), we calculated that sample side should be 300 patients for arms. This sample size achieves 90% power to detect a difference of 10% .
Key inclusion criteria (2 listed)
- Signed written informed consent according to ICH/EU/GCP and national/local laws
- Patients aged older than 60 years underwent to consolidation course with intermediate/high doses of cytarabine
Key exclusion criteria (1 listed)
- Diagnosis of IA during induction course and previous antifungal treatment
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
the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients
Time frame: 60 months
rate of IA
1 secondary outcome
overall mortality rate
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
Maria Ilaria Del Principe principal investigator
University of Rome Tor Vergata
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 Invasive Aspergillosis, run by University of Rome Tor Vergata 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 2 inclusion and 1 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 29 Apr 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 Maria Ilaria Del Principe, Prof (3394080659, del.principe@med.uniroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients (time frame: 60 months). 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 29 Apr 2024.