Long-term Follow-up Study of BRL-101 for TDT
- Conditions
- Thalassemia, Beta
- Interventions
- Other: Assessments
- Registration Number
- NCT06298630
- Lead Sponsor
- Bioray Laboratories
- Brief Summary
Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.
- Detailed Description
Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
- Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
- Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.
- There are no exclusion criteria for this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BRL-101 Assessments All patients who have received BRL-101
- Primary Outcome Measures
Name Time Method Incidence of hematologic malignancies Up to 15 years post-drug product infusion Such as new lymphoma, leukemia, MDS, etc.
Frequency, grade, and relationship of SAEs Within 2 years to 5years after BRL-101 Infusion Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Shenzhen Children 's Hospital
🇨🇳Shenzhen, Guangdong, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital
🇨🇳Nanning, Guangxi, China
Tianjin Institute of Hematology
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY
🇨🇳Guangxi, China