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

NCT ID: NCT07238907

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-07-31

Brief 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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

observation group

Inotuzumab Ozogamicin

Intervention Type: DRUG

All patients have received Inotuzumab Ozogamicin

Interventions

Inotuzumab Ozogamicin

All patients have received Inotuzumab Ozogamicin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Wang

chief physician, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

RJ-ALL 2025-B03

Identifier Type: -

Identifier Source: org_study_id