A Multi-center Retrospective Study of INO Treating B-ALL

N/AActive Not RecruitingNCT07238907

Ruijin Hospital102 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Acute Lymphoblastic Leukaemia Acute Lymphoblastic Leukaemias (ALL)Inotuzumab Ozogamicin Venetoclax

Interventions

Inotuzumab OzogamicinDRUG

All patients have received Inotuzumab Ozogamicin

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

overall response rate

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.