Long-term Follow-up Study of BRL-101 for TDT
1 other identifier
observational
45
1 country
7
Brief Summary
Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2024
Longer than P75 for all trials
7 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
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedStudy Start
First participant enrolled
December 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 15, 2038
July 21, 2026
July 1, 2026
13.7 years
March 1, 2024
July 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of hematologic malignancies
Such as new lymphoma, leukemia, MDS, etc.
Up to 15 years post-drug product infusion
Frequency, grade, and relationship of SAEs
Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion.
Within 2 years to 5years after BRL-101 Infusion
Study Arms (1)
BRL-101
All patients who have received BRL-101
Interventions
Eligibility Criteria
Subjects with transfusion-dependent β-thalassemia who have been treated with BRL-101.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bioray Laboratorieslead
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Chinese Academy of Medical Sciencescollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- The 923rd Hospital of Joint Logistics Support Force of People's Liberation Armycollaborator
- Shenzhen Children's Hospitalcollaborator
Study Sites (7)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510006, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510006, China
Shenzhen Children 's Hospital
Shenzhen, Guangdong, 510006, China
No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital
Nanning, Guangxi, 530021, China
Xiangya Hospital of Central South University
Changsha, Hunan, 510510, China
Tianjin Institute of Hematology
Tianjin, Tianjin Municipality, 300000, China
The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY
Guangxi, 530021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rongmei Liang, PhD
Bioray Laboratories
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 7, 2024
Study Start
December 8, 2024
Primary Completion (Estimated)
August 20, 2038
Study Completion (Estimated)
October 15, 2038
Last Updated
July 21, 2026
Record last verified: 2026-07