A Retrospective, Observational, and Multicenter Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 275
- Locations
- 1
- Primary Endpoint
- overall response rate(for R/R patients)
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 14 years old;
- •Diagnosed with CD19+B-cell acute lymphoblastic leukemia \[refer to the Chinese Guidelines for Diagnosis and Treatment of Adult Acute lymphoblastic Leukemia (2024 edition)\];
- •Patients who have received treatment with CNCT-19.
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:
- •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;
- •Individuals known to have a history of hypersensitivity reactions to the components of the formulation used in the experiment.
Arms & Interventions
observation group
Intervention: CNCT-19 (Drug)
Outcomes
Primary Outcomes
overall response rate(for R/R patients)
Time Frame: 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)
Time Frame: 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 Outcomes
- incidence of Adverse Events(AEs)(up to 24 months)
- incidence of Severe Adverse Events(SAEs)(up to 24 months)
- DOR(Duration Of Remission)(till the end of the study, up to 24 months)
- rate of Allogeneic hematopoietic stem cell transplantation(till the end of the study, up to 24 months)
- Relapse-free survival (RFS)(till the end of the study, up to 24 months)
- Overall Survival(OS)(till the end of the study, up to 24 months)
Investigators
Jin Wang
chief physician, MD, PhD
Ruijin Hospital