Clinical trial NCT06450067: Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: B-cell Acute Lymphoblastic Leukemia
Lead sponsor: Juventas Cell Therapy Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with adult relapsed or refractory B-cell acute lymphoblastic leukemia.

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).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;
3. Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;
4. 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

Primary outcomes:
measure: overall survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong university
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Jianxiang Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Aibin Liang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: