Clinical trial · Observational
A Multi-center Retrospective Study of INO Treating B-ALL
A Multi-center Retrospective Study of Inotuzumab Ozogamicin Treating Acute B-cell Lymphoblastic Leukemia
NCT07238907CI-TRIAL-00097892active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This multi-center retrospective study aims to evaluate the efficacy and safety of inotuzumab ozogamicin in adults B-ALL of different subgroups. This study is a retrospective study. Data will be collected from Electronic Medical Record, interventions will not be implemented on patients.
Conditions
Conditions (4)
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 Leukaemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Lymphoblastic Leukaemias (ALL) | Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| Inotuzumab Ozogamicin | — | UNRESOLVED | — |
| Venetoclax | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inotuzumab Ozogamicin | Drug | Inotuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- observation group
- interventionNames
- Drug: Inotuzumab Ozogamicin
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- Till the end of the study, up to 12 months
- description
- The proportion of patients who reach CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
Secondary outcomes (4)
- measure
- minimal residual disease negativity rate
- timeFrame
- Till the end of the study, up to 12 months
- description
- The proportion of patients who reach MRD negative in all patients reached CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age between ≥16 and ≤80 years at screening, no gender restrictions * Be diagnosed with B-ALL * Appropirate organ function, meeting the following criteria: 1. Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); 2. Alanine aminotransferase (ALT) ≤3 times ULN; 3. Total bilirubin ≤2 times ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN); 4. Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula); 5. Left ventricular ejection fraction (LVEF) ≥50%; Exclusion Criteria: * Active infection at screening. * Any of the following cardiac conditions: 1. NYHA Class III or IV congestive heart failure; 2. Severe arrhythmia requiring treatment; 3. Uncontrolled hypertension or pulmonary hypertension despite standard therapy; 4. Unstable angina; 5. Myocardial infarction, bypass surgery, or stent placement within six months before cell retransfusion; 6. Clinically significant valvular disease; 7. Other cardiac conditions deemed unsuitable by the investigator; * History of epilepsy, cerebellar disease, or other active central nervous system disorders; * History of hypersensitivity to any component of the investigational product. * Life expectancy of less than three months; * Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.