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A Multi-center Retrospective Study of INO Treating B-ALL | Clinical Trials | Clareo Health

ACTIVE_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

NCT07238907•Ruijin Hospital

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

Age

16 - 80 years

Sex

ALL

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;
+3 more criteria

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 1, 2022

Primary Completion Date

June 30, 2025

Completion Date

July 31, 2026

Last Updated

November 25, 2025

Enrollment

102

ACTUAL participants

Conditions

Acute Lymphoblastic LeukaemiaAcute Lymphoblastic Leukaemias (ALL)Inotuzumab OzogamicinVenetoclax

Interventions

Inotuzumab Ozogamicin

DRUG

Blinatumomab Consolidation in Real World

NCT07117136

B-Cell Acute Lymphoblastic Leukaemia

View study

RECRUITINGPHASE2

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

NCT06355583

Acute Lymphoblastic LeukaemiaAcute Leukemia of Ambiguous Lineage+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Blinatumomab Consolidation in Real World

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies

Monoclonal Antibodies in Recurrent or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL) (MARALL)

Osteonecroses in Pediatric Patients With ALL

Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia