An observational study in Acute Lymphoblastic Leukemia, Infections and Bacterial Infections, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational
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:
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).
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 158 is above the median of 108 across 400 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 135 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: 5 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Gruppo Italiano Malattie EMatologiche dell'Adulto →