Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: B-cell Acute Lymphoblastic Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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).
Primary outcome measures
- overall survival [Time frame: 2 years]
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
None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 10 centers
- Peking University People's Hospital — Beijing
- Peking University Third Hospital — Beijing
- Zhujiang Hospital of Southern Medical University — Guangzhou
- Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou
- Qilu Hospital of Shandong university — Jinan
- Tongji Hospital of Tongji University — Shanghai
- … and 2 more centers
Identifiers
NCT: NCT06450067 · HY001402