An observational study in Acute Lymphoblastic Leukaemia, Acute Lymphoblastic Leukaemias (ALL) and Inotuzumab Ozogamicin, sponsored by Ruijin Hospital. Active, not recruiting at 1 site in China. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Ruijin Hospital · Observational
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.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 491 are open to participants now.
This study's enrollment of 102 is below the median of 120 across 300 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients received INO-based therapy in all participant center of this study
Appropirate organ function, meeting the following criteria:
Exclusion Criteria:
Any of the following cardiac conditions:
Drug: Inotuzumab Ozogamicin
All patients have received Inotuzumab Ozogamicin
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.
Time frame: Till the end of the study, up to 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Till the end of the study, up to 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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