Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia
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
1 other identifier
observational
200
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2024
CompletedStudy Start
First participant enrolled
June 5, 2024
CompletedFirst Posted
Study publicly available on registry
June 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 5, 2029
September 19, 2024
September 1, 2024
2 years
June 3, 2024
September 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia
Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia
Eligibility Criteria
Diagnosed with adult relapsed or refractory B-cell acute lymphoblastic leukemia.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Peking University People's Hospital
Beijing, Beijing Municipality, 100000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, 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 Municipality, China
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianxiang Wang, Dr.
Institute of Hematology & Blood Diseases Hospital, China
- PRINCIPAL INVESTIGATOR
Aibin Liang, Dr.
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2024
First Posted
June 10, 2024
Study Start
June 5, 2024
Primary Completion (Estimated)
June 5, 2026
Study Completion (Estimated)
June 5, 2029
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share