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

A Multi-center Retrospective Study of Inotuzumab Ozogamicin Treating Acute B-cell Lymphoblastic Leukemia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Lymphoblastic Leukaemia; Acute Lymphoblastic Leukaemias (ALL); Venetoclax; Inotuzumab Ozogamicin
• Intervention / Treatment: Drug: Inotuzumab Ozogamicin

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observation group	Drug: Inotuzumab Ozogamicin; All patients have received Inotuzumab Ozogamicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
minimal residual disease negativity rate	The proportion of patients who reach MRD negative in all patients reached 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
overall survival	Interval from the date of the feedback to the time of death due to any reason. Evaluation of OS will be based on follow-up results.	Till the end of the study, up to 12 months
Relapse-free survival	Interval from the date of reception of the INO-based therapy to the time of hematological recurrence or death from any cause. Evaluation of RFS will be based on follow-up results.	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.	Hematological toxicity includes: neutropenia, thrombocytopenia, febrile neutropenia, anemia, and bone marrow suppression Non hematological toxicity includes sinus obstruction syndrome(SOS), tumor lysis syndrome(TLS), peripheral edema, fever, fatigue, multiple organ dysfunction syndrome(MODS), infection, liver dysfunction, renal dysfunction, abnormal blood electrolytes, and infusion reactions. All AEs will be assessed by CTCAE v5.0	Till the end of the study, up to 12 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Amino Acids, Peptides, and Proteins; Proteins; Carbohydrates; Glycosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Aminoglycosides; Calicheamicins; Inotuzumab Ozogamicin
• Other Study ID Numbers: RJ-ALL 2025-B03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No