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

NCT07238907 | Active Not Recruiting

• 1 other identifier: RJ-ALL 2025-B03
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Till the end of the study, up to 12 months

Secondary Outcomes (4)

• minimal residual disease negativity rate

  Till the end of the study, up to 12 months

• overall survival

  Till the end of the study, up to 12 months

• Relapse-free survival

  Till the end of the study, up to 12 months

• Hematological toxicity: neutropenia, thrombocytopenia, febrile neutropenia, anemia, bone marrow suppression Non hematological toxicity: SOS,TLS, peripheral edema, fever, fatigue, MODS, infection, liver dysfunction, renal dysfunction et al.

  Till the end of the study, up to 12 months

Study Arms (1)

observation group

Drug: Inotuzumab Ozogamicin

Interventions

Inotuzumab Ozogamicin DRUG

All patients have received Inotuzumab Ozogamicin

observation group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients received INO-based therapy in all participant center of this study

You may qualify if:

• 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%;

You may not qualify if:

• Active infection at screening.
• 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 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Inotuzumab Ozogamicin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician, MD, PhD

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 20, 2025
• Study Start: June 1, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CN (1)