Inotuzumab Ozogamicin: All patients have received Inotuzumab Ozogamicin
Study summary
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.
Eligibility
Sex
ALL
Min age
16 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
overall response rate — Till the end of the study, up to 12 months 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.
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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