To Observe and Evaluate the Efficacy and Safety of Inaticabtagene Autoleucel Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Adults in the Real World
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Sponsor
- Juventas Cell Therapy Ltd.
- Enrollment
- 200
- Locations
- 10
- Primary Endpoint
- overall survival
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.
Detailed Description
The study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in the treatment of Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years;
- •Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;
- •Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;
- •Patients voluntarily participate in this study and sign an informed consent form. For patients lacking full legal capacity, informed consent must be obtained from their legal guardian
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
overall survival
Time Frame: 2 years
OS is defined as the time from the start date of Inaticabtagene Autoleucel Injection infusion to the date of death due to any cause.