ALL (Acute B-Lymphoblastic Leukemia), CAR-T Cell Therapy
Conditions
Brief summary
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.
Interventions
DRUGCNCT-19
All patients have received CNCT-19
Sponsors
Ruijin Hospital
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 14 years old; 2. Diagnosed with CD19+B-cell acute lymphoblastic leukemia \[refer to the Chinese Guidelines for Diagnosis and Treatment of Adult Acute lymphoblastic Leukemia (2024 edition)\]; 3. Patients who have received treatment with CNCT-19.
Exclusion criteria
1. 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; 2. Active systemic autoimmune diseases during treatment; 3. Those who meet any of the following criteria: * Positive hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); * hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; * Hepatitis C antibody (HCV Ab) positive; * Positive for Treponema pallidum antibody (TP Ab); * Positive human immunodeficiency virus (HIV) antibody test; * EBV-DNA and CMV-DNA copy numbers are greater than the measurable lower limit; 4. Individuals known to have a history of hypersensitivity reactions to the components of the formulation used in the experiment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate(for R/R patients) | Till the end of the study, up to 24 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. |
| minimal residual disease negativity rate(for MRD positive patients) | Till the end of the study, up to 24 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOR(Duration Of Remission) | till the end of the study, up to 24 months | Time from the first assessment of MRD negative to the first assessment of MRD positive or death from any cause. |
| rate of Allogeneic hematopoietic stem cell transplantation | till the end of the study, up to 24 months | The proportion of patients who receive allo-HSCT after CNCT19 treatment. |
| incidence of Adverse Events(AEs) | up to 24 months | The proportion of patients who have adverse events after CNCT-19 treatment.Adverse events will be assessed by CTCAE v5.0 |
| incidence of Severe Adverse Events(SAEs) | up to 24 months | 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. |
| Relapse-free survival (RFS) | till the end of the study, up to 24 months | 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. |
| Overall Survival(OS) | till the end of the study, up to 24 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. |
Countries
China
Outcome results
None listed