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Active, Not Recruiting

NCT Number: NCT07238907

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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:
  • 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%;

Exclusion criteria

  • 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.

Treatment and study plan

Inotuzumab ozogamicin

Drug

All patients have received Inotuzumab Ozogamicin

Primary outcomes

  1. overall response rate

    Time frame: Till the end of the study, up to 12 months

    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.

Secondary outcomes

  1. minimal residual disease negativity rate

    Time frame: Till the end of the study, up to 12 months

    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.

  2. overall survival

    Time frame: Till the end of the study, up to 12 months

    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.

  3. Relapse-free survival

    Time frame: Till the end of the study, up to 12 months

    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.

  4. 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.

    Time frame: Till the end of the study, up to 12 months

    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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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