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

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Acute Lymphoblastic Leukaemias (ALL); Acute Lymphoblastic Leukaemia; Inotuzumab Ozogamicin; Venetoclax

Treatments: Drug: Inotuzumab Ozogamicin

Study type: Observational

Funder types: Other

Identifiers

NCT07238907

RJ-ALL 2025-B03

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

102 participants in 1 patient group

observation group

Treatment:

Drug: Inotuzumab Ozogamicin