Acute Lymphoblastic LeukemiaINO-FIRSTNCT06025682
Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO
An observational study of Acute Lymphoblastic Leukemia and Infections, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 1 site in Italy.
Trial summary
The goal of this observational study is to learn about infectious complications in patients affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Infections, Bacterial Infections
- How many people
- 158 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2024to Jan 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: Adult patients with relapsed/refractory CD22 positive acute lymphoblastic leukemia treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one TKI inhibitor
Who may be able to join
- Adult patients (>18 years old)
- Patients with relapsed/refractory CD22 positive B-ALL treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one TKI inhibitor
- Signed informed consent if applicable.
Who cannot join
- Patients treated with INO in interventional clinical trials.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UOC Ematologia Fondazione Policlinico Universitario A.Gemelli
Roma
Luana Fianchi
About this study
Official title: Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)
The goal of this observational study is to learn about infectious complications in patients affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The main question it aims to answer is:
- incidence of infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin up to 60 days after the end of treatment
Read the detailed description
The present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin (INO) over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).
- Conditions
- Acute Lymphoblastic Leukemia, Infections, Bacterial Infections, Viral Infection, Fungal Infection, Acute Lymphoblastic Leukemia, Adult
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Infections, Bacterial Infections, Virus Diseases, Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinically or microbiologically documented infectious complications in patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered)
To estimate the rate of clinically or microbiologically documented infectious complications (bacterial, fungal, viral) in acute lymphoblastic leukemia patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start4 Apr 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Livio Pagano, Principal investigator, Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025682
- Sponsor's protocol ID
- INF0123
- Acronym
- INO-FIRST
- Status last verified
- Apr 2024
- First submitted
- 29 Aug 2023
- Last updated
- 11 Apr 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)
- ClinicalTrials.gov ID
- NCT06025682
- Acronym / sponsor ID
- INO-FIRST / INF0123
- Conditions
- Acute Lymphoblastic Leukemia, Infections, Bacterial Infections, Viral Infection, Fungal Infection, Acute Lymphoblastic Leukemia, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 6 Sep 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 goal of this observational study is to learn about infectious complications in patients affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The main question it aims to answer is:
- incidence of infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin up to 60 days after the end of treatment
Detailed description
The present study is a multicenter, retrospective, observational clinical-epidemiological study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin (INO) over the last 5 years (2018-2023), according to the authorized indications and not included in interventional clinical trials (randomized or not randomized).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with relapsed/refractory CD22 positive acute lymphoblastic leukemia treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one TKI inhibitor
Key inclusion criteria (3 listed)
- Adult patients (>18 years old)
- Patients with relapsed/refractory CD22 positive B-ALL treated with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing at least one TKI inhibitor
- Signed informed consent if applicable.
Key exclusion criteria (1 listed)
- Patients treated with INO in interventional clinical trials.
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
Rate of clinically or microbiologically documented infectious complications in patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered)
Time frame: 5 months
To estimate the rate of clinically or microbiologically documented infectious complications (bacterial, fungal, viral) in acute lymphoblastic leukemia patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
Livio Pagano principal investigator
Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Roma
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 and Infections, run by Gruppo Italiano Malattie EMatologiche dell'Adulto 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 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 11 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 Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinically or microbiologically documented infectious complications in patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered) (time frame: 5 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 11 Apr 2024.