Clinical trial · Observational
ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In phase 2 and phase 3 studies, inotuzumab has shown evidence of single agent anti-leukemic activity and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2014 anti-CD22 has been available for compassionate use in Italy. In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with ALL, to improve the knowledge about anti-CD22 treatment in clinical practice. Collecting data of patients and analyzing a large unbiased patient-set of patients receiving anti-CD22 immunoconjugates could enlarge our knowledge on therapies engaging CD22
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD22 Immunotoxin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of Adverse Events of grade 3 and 4
- timeFrame
- up to 12 months
- description
- toxicity profile of the therapy with antiCD22 immunoconjugates in patients with ALL
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- up to 18 months
- description
- Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause
- measure
- Disease free survival
- timeFrame
- up to 18 months
- description
- Disease Free Survival (DFS), defined as the number of days between the first study drug administration and any event including disease progression or death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with ALL according WHO 2016 classification. 2. Patient who received any anti-CD22 immunoconjugate from 2014 to 01-Mar-2019 outside clinical trials. Exclusion Criteria: 1\. Patients who received anti-CD22 treatment within a clinical trial
References
Publications (0)
Data not yet available