This clinical study is a retrospective, observational, and multicenter post marketing real-world study aimed at evaluating the efficacy and safety of CNCT-19 in the treatment of Chinese adult B-cell acute lymphoblastic leukemia patients.
Study Type
OBSERVATIONAL
Enrollment
275
All patients have received CNCT-19
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
overall response rate(for R/R patients)
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 24 months
minimal residual disease negativity rate(for MRD positive patients)
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 24 months
DOR(Duration Of Remission)
Time from the first assessment of MRD negative to the first assessment of MRD positive or death from any cause.
Time frame: till the end of the study, up to 24 months
rate of Allogeneic hematopoietic stem cell transplantation
The proportion of patients who receive allo-HSCT after CNCT19 treatment.
Time frame: till the end of the study, up to 24 months
Relapse-free survival (RFS)
Interval from the date of treatment of the CNCT-19 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 24 months
Overall Survival(OS)
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 24 months
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incidence of Adverse Events(AEs)
The proportion of patients who have adverse events after CNCT-19 treatment.Adverse events will be assessed by CTCAE v5.0
Time frame: up to 24 months
incidence of Severe Adverse Events(SAEs)
The proportion of patients who have severe adverse events after CNCT-19 treatment.Adverse events with one of the following damages should be classified as serious drug adverse events: 1. Causing death; 2. Endangering life; 3. Causing hospitalization or prolonged hospitalization time; 4. Causing permanent or significant disability/loss of function; 5. Congenital abnormalities/birth defects; 6. Causing other important medical events that, if left untreated, may result in the situations listed above.
Time frame: up to 24 months