Acute Myeloid LeukemiaGilteRInfNCT05791890
GilteRInf 2022 Study (Gilteritinib Related Infections)
An observational study of Acute Myeloid Leukemia, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
The study is observational, retrospective-prospective, multicenter "real-life" study involving 26 centers belonging to the SEIFEM group. The goal of this study is to obtain a real-life experience in the management and outcome of infectious issues of patients with relapsed/resistant acute myeloid leukemia who receive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Gilteritinib
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2022to 31 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Relapsed/refractory AML patients
Who may be able to join
- Population
- All patients with FLT3+ relapsed/refractory AML to any line of therapy treated with Gilteritinib
- Patients ≥18 years of age
- Signature of appropriate informed consent
Who cannot join
- Patients < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Incidence of Infections in Patients With Relapsed/Refractory FMS-like Tyrosine Kinase 3 Acute Myeloid Leukemia Treated With Gilteritinib
The study is observational, retrospective-prospective, multicenter "real-life" study involving 26 centers belonging to the SEIFEM group. The goal of this study is to obtain a real-life experience in the management and outcome of infectious issues of patients with relapsed/resistant acute myeloid leukemia who receive Gilteritinib therapy, given that recent approval of this drug.
Read the detailed description
The study is observational, retrospective-prospective, multicenter "real-life" study. Regarding the retrospective part, clinical data will be collected on all patients with acute myeloid leukemia FLT3+ treated with Gilteritinib from when the drug was approved and marketed in Italy (April 2, 2020) until April 30, 2022. Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval. Patients enrolled in the last month will be followed for six months from the date of enrollment to check for the occurrence of any infections. For each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with relapsed/refractory FLT3+ acute myeloid leukemia on salvage chemotherapy should also be included.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Gilteritinib
- Keywords
- relapsed/refractory acute myeloid leukemia, FLT3+, FLT3 inhibitors, Gilteritinib, infections
- Medical subject headings
- Leukemia, Myeloid, Acute, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GilteritinibDrug
observational study to evaluate the incidence of infections during therapy with Gilteritinb
| Study group | Role | What they receive |
|---|---|---|
| Patients who receive or have received Gilteritinib | the retrospective part, clinical data will be collected on all patients with LMA FLT3+ (ITD or TKD mutation) treated with Gilteritinib from when the drug was approved and marketed in Italy (April 2, 2020) until April 30, 2022. Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval. Receives: Drug: Gilteritinib | |
| Case control | for each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with R/R AML FLT3+ on salvage chemotherapy should also be included. Receives: Drug: Gilteritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 )
To assess "real-life" in patients with relapsed/refractory FLT3+ LMA treated with Gilteritinib the absolute infectious risk and compare it with relapsed/refractory patients receiving chemotherapy. The
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start31 May 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 78 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, Prof, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791890
- Sponsor's protocol ID
- GilteRInf 2022
- Acronym
- GilteRInf
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Incidence of Infections in Patients With Relapsed/Refractory FMS-like Tyrosine Kinase 3 Acute Myeloid Leukemia Treated With Gilteritinib
- ClinicalTrials.gov ID
- NCT05791890
- Acronym / sponsor ID
- GilteRInf / GilteRInf 2022
- Conditions
- Acute Myeloid Leukemia
- Keywords
- relapsed/refractory acute myeloid leukemia, FLT3+, FLT3 inhibitors, Gilteritinib, infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Mar 2023 (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.
The study is observational, retrospective-prospective, multicenter "real-life" study involving 26 centers belonging to the SEIFEM group. The goal of this study is to obtain a real-life experience in the management and outcome of infectious issues of patients with relapsed/resistant acute myeloid leukemia who receive Gilteritinib therapy, given that recent approval of this drug.
Detailed description
The study is observational, retrospective-prospective, multicenter "real-life" study. Regarding the retrospective part, clinical data will be collected on all patients with acute myeloid leukemia FLT3+ treated with Gilteritinib from when the drug was approved and marketed in Italy (April 2, 2020) until April 30, 2022. Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval. Patients enrolled in the last month will be followed for six months from the date of enrollment to check for the occurrence of any infections. For each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with relapsed/refractory FLT3+ acute myeloid leukemia on salvage chemotherapy should also be included.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who receive or have received Gilteritinib | – | Drug: Gilteritinibthe retrospective part, clinical data will be collected on all patients with LMA FLT3+ (ITD or TKD mutation) treated with Gilteritinib from when the drug was approved and marketed in Italy (April 2, 2020) until April 30, 2022. Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval. |
| Case control | – | Drug: Gilteritinibfor each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with R/R AML FLT3+ on salvage chemotherapy should also be included. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relapsed/refractory AML patients
Key inclusion criteria (4 listed)
- Population
- All patients with FLT3+ relapsed/refractory AML to any line of therapy treated with Gilteritinib
- Patients ≥18 years of age
- Signature of appropriate informed consent
Key exclusion criteria (1 listed)
- Patients < 18 years old
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 |
|---|---|---|
| Gilteritinibobservational study to evaluate the incidence of infections during therapy with Gilteritinb | Drug | Case control, Patients who receive or have received Gilteritinib |
Primary outcome
absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 )
Time frame: 24 months
To assess "real-life" in patients with relapsed/refractory FLT3+ LMA treated with Gilteritinib the absolute infectious risk and compare it with relapsed/refractory patients receiving chemotherapy. The
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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, Prof 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 Acute Myeloid Leukemia, 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 4 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 30 Mar 2023. 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?
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?
absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 ) (time frame: 24 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 30 Mar 2023.