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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia | Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia |
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| Measure | Description | Time Frame |
|---|---|---|
| overall survival | OS is defined as the time from the start date of Inaticabtagene Autoleucel Injection infusion to the date of death due to any cause. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
None
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Diagnosed with adult relapsed or refractory B-cell acute lymphoblastic leukemia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qinghan Wang, master | Contact | 86-13439319658 | 352074861@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianxiang Wang, Dr. | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Aibin Liang, Dr. | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | China |
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| Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
|
| Qilu Hospital of Shandong university | Recruiting | Jinan | Shandong | China |
|
| Tongji Hospital of Tongji University | Recruiting | Shanghai | Shanghai Municipality | China |
|
| West China School of Medicine/West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
|
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |