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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observation group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNCT-19 | Drug | All patients have received CNCT-19 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Till the end of the study, up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| DOR(Duration Of Remission) | Time from the first assessment of MRD negative to the first assessment of MRD positive or death from any cause. | till the end of the study, up to 24 months |
| rate of Allogeneic hematopoietic stem cell transplantation |
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Inclusion Criteria:
Exclusion Criteria:
Individuals with acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within the first 4 weeks of screening; Individuals who have received systemic drug therapy for GVHD within the past 4 weeks prior to reinfusion;
Active systemic autoimmune diseases during treatment;
Those who meet any of the following criteria:
Individuals known to have a history of hypersensitivity reactions to the components of the formulation used in the experiment.
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Patients received CNCT-19 treatment in all participant center of this study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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The proportion of patients who receive allo-HSCT after CNCT19 treatment.
| 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. | 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. | till the end of the study, up to 24 months |
| 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 | 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:
| up to 24 months |