Acute Myeloid LeukemiaIA-AMLNCT02900430
Invasives Aspergillosis in Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia and Invasive Aspergillosis, run by University Hospital, Brest at 1 site in France.
Trial summary
Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Invasive Aspergillosis
- What is being tested?
- Patients without antifungal prophylaxis and Patients with antifungal prophylaxis
- How many people
- 246 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2015
- 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: Adults patients treated for acute myeloid leukemia by intensive chemotherapy
Who may be able to join
- > 18 years
- acute myeloid leukemia
- intensive chemotherapy (induction, consolidation, salvage, bone marrow transplantation)
Who cannot join
- < 18 years
- pregnancy
- no intensive chemotherapy (palliative treatment, azacytidine...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia
Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.
Read the detailed description
Invasive aspergillosis are frequent infections in hematological malignancy in particular during neutropenia induced by chemotherapy. Their incidence ranged between 5 to 25% according to the literature. Mortality may reach 30%. Our study described IA incidence in AML patients treated by intensive chemotherapy depending on antifungal prophylaxis by posaconazole. From 2009 to 2011, any patients received antifungal prophylaxis. From 2012 to 2015, patients received posaconazole during induction and salvage chemotherapy. During the all study period, efficacy of posaconazole is evaluated according to construction/demolition periods in hospital. All patients are hospitalized in High Efficiency Particulate Air (HEPA) filtration system.
- Conditions
- Acute Myeloid Leukemia, Invasive Aspergillosis
- Being tested
- Patients without antifungal prophylaxis, Patients with antifungal prophylaxis
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients without antifungal prophylaxisOther
Epidemiology data: clinical and biological informations collecting
Patients with antifungal prophylaxisDrug
Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients without antifungal prophylaxis | Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2009 to 2011, any patient received antifungal (anti-aspergillosis) prophylaxis. Receives: Other: Patients without antifungal prophylaxis | |
| Patients with antifungal prophylaxis | Patients with acute myeloid leukemia treated with intensive chemotherapy. From 2012 to 2015, all patients received antifungal (anti-aspergillosis) prophylaxis by posaconazole. Receives: Other: Patients without antifungal prophylaxis; Drug: Patients with antifungal prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of invasive aspergillosis in acute myeloid leukemia
Evaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015
Measured: 1 year
Secondary outcomes (2)
Efficiency of antifungal prophylaxis by posaconazole
Comparison of two periods: 2009-2011 where patients had not antifungal prophylaxis and 2012-2015 where patients had antifungal prophylaxis by posaconazole during induction and salvage chemotherapy
Measured: 1 year
Impact of antifungal prophylaxis by posaconazole about construction/demolition periods
Comparison of incidence of invasive aspergillosis while antifungal prophylaxis and construction/demolition periods
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaelle Guillerm, MD, Principal investigator, Department of Hematology, Brest Teaching HospitalLenaig Le Clech, MD, Principal investigator, Department of Hematology, Brest Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900430
- Sponsor's protocol ID
- IA-AML
- Acronym
- IA-AML
- Status last verified
- Sep 2016
- First submitted
- 2 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02900430
- Acronym / sponsor ID
- IA-AML / IA-AML
- Conditions
- Acute Myeloid Leukemia, Invasive Aspergillosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Sep 2016 (estimated)
- 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.
Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.
Detailed description
Invasive aspergillosis are frequent infections in hematological malignancy in particular during neutropenia induced by chemotherapy. Their incidence ranged between 5 to 25% according to the literature. Mortality may reach 30%. Our study described IA incidence in AML patients treated by intensive chemotherapy depending on antifungal prophylaxis by posaconazole. From 2009 to 2011, any patients received antifungal prophylaxis. From 2012 to 2015, patients received posaconazole during induction and salvage chemotherapy. During the all study period, efficacy of posaconazole is evaluated according to construction/demolition periods in hospital. All patients are hospitalized in High Efficiency Particulate Air (HEPA) filtration system.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without antifungal prophylaxis | – | Other: Patients without antifungal prophylaxisPatients with acute myeloid leukemia treated with intensive chemotherapy. From 2009 to 2011, any patient received antifungal (anti-aspergillosis) prophylaxis. |
| Patients with antifungal prophylaxis | – | Other: Patients without antifungal prophylaxis, Drug: Patients with antifungal prophylaxisPatients with acute myeloid leukemia treated with intensive chemotherapy. From 2012 to 2015, all patients received antifungal (anti-aspergillosis) prophylaxis by posaconazole. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients treated for acute myeloid leukemia by intensive chemotherapy
Key inclusion criteria (3 listed)
- > 18 years
- acute myeloid leukemia
- intensive chemotherapy (induction, consolidation, salvage, bone marrow transplantation)
Key exclusion criteria (3 listed)
- < 18 years
- pregnancy
- no intensive chemotherapy (palliative treatment, azacytidine...)
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 |
|---|---|---|
| Patients without antifungal prophylaxisEpidemiology data: clinical and biological informations collecting | Other | Patients with antifungal prophylaxis, Patients without antifungal prophylaxis |
| Patients with antifungal prophylaxisHospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy. | Drug | Patients with antifungal prophylaxis |
Primary outcome
Incidence of invasive aspergillosis in acute myeloid leukemia
Time frame: 1 year
Evaluation of annual incidence of invasive aspergillosis in acute myeloid leukemia treated by intensive chemotherapy between 2009 and 2015
2 secondary outcomes
Efficiency of antifungal prophylaxis by posaconazole
Time frame: 1 year
Impact of antifungal prophylaxis by posaconazole about construction/demolition periods
Time frame: 1 year
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 14 Sep 2016.
- 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.
Gaelle Guillerm, MD principal investigator
Department of Hematology, Brest Teaching Hospital
Lenaig Le Clech, MD principal investigator
Department of Hematology, Brest Teaching Hospital
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 Myeloid Leukemia and Invasive Aspergillosis, run by University Hospital, Brest at 1 site in France.
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: finished, as of the sponsor's last update on 14 Sep 2016. 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 France. 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?
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?
Incidence of invasive aspergillosis in acute myeloid leukemia (time frame: 1 year). 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 14 Sep 2016.