Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Registration Number
- NCT06450067
- Lead Sponsor
- Juventas Cell Therapy Ltd.
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Qilu Hospital of Shandong university
🇨🇳Jinan, Shandong, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
West China School of Medicine/West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital
🇨🇳Tianjin, Tianjin, China