Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
NCT Number: NCT07238907
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.
This study is active but is not currently recruiting participants.
16 year–80 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200025, China
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients have received Inotuzumab Ozogamicin
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.
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.
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.
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.
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
Ruijin Hospital
Other
A Multi-center Retrospective Study of Inotuzumab Ozogamicin Treating Acute B-cell Lymphoblastic Leukemia
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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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