NCT07238907Active, not recruiting
A Multi-center Retrospective Study of INO Treating B-ALL
A Multi-center Retrospective Study of Inotuzumab Ozogamicin Treating Acute B-cell Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 102 (actual)
- First submitted
- 22 Sept 2025
- Start date
- 1 Jun 2022
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Ruijin Hospital
- NCT number
- NCT07238907
What you commit to
- Study type: Observational
- Participants enrolled: 102
- From 1 Jun 2022 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any of the following cardiac conditions:
- NYHA Class III or IV congestive heart failure;
- Severe arrhythmia requiring treatment;
- Uncontrolled hypertension or pulmonary hypertension despite standard therapy;
- Unstable angina;
- Myocardial infarction, bypass surgery, or stent placement within six months before cell retransfusion;
- Clinically significant valvular disease;
- Other cardiac conditions deemed unsuitable by the investigator;
- History of hypersensitivity to any component of the investigational product.
Other illness
- Active infection at screening.
- History of epilepsy, cerebellar disease, or other active central nervous system disorders;
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Other
- Life expectancy of less than three months;
Who the study is looking for
- Age between ≥16 and ≤80 years at screening, no gender restrictions
- Be diagnosed with B-ALL
- Appropirate organ function, meeting the following criteria:
- Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) ≤3 times ULN;
- Total bilirubin ≤2 times ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN);
- Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula);
- Left ventricular ejection fraction (LVEF) ≥50%;
Age in the registry: 16 years to 80 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.