CAR-T Treatment in Pediatric and Adult Acute Lymphoblastic Leukemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
About this trial
The goal of this observational study is to evaluate the efficacy of the treatment with approved CAR-T cells in Italy in pediatric and adult patients with acute B-cell lymphoblastic leukemia. The main question it aims to answer is:
which is the overall response rate in pediatric and adult patients with acute B-cell lymphoblastic leukemia treated with approved CAR-T cells?
Data will be extracted from patients medical records.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of ALL R/R CD19+
Patients are pediatric (all patients up to the age of 18) adult (all comers older than 18)
Prescribed treatment with Tisagenlecleucel or Brexucabtagene autoleucel as per approved AIFA criteria, or obecabtagene autoleucel - as well as other products - when available
Provided consent (or did not opposed) for collection and use of patient data per local regulations
Disqualifiers
None
Trial population
Pediatric and adult patients with relapse/refractory B-cell lymphoblastic leukemia with a prescription of CAR-T cell therapy in the clinical practice
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
107 Participants
are grouped into 1 trial groupGroup A: Patients with acute lymphoblastic leukemia treated with CAR-T cells
Trial outcomes
Primary outcomes
1
Overall response
Rate of patients that obatain a response
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: