A Safety and Effectiveness Registry Study of Patients with Β-Thalassemia Treated with Betibeglogene Autotemcel (the Glostar Registry)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. To assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Participant must be treated with beti-cel in the post marketing setting at a center in the US that participates in the Registry.

• Participant must sign an informed consent and/or assent prior to enrollment as required under applicable laws and regulations.

• Participant must have signed an informed consent and/or assent permitting data to be shared with Center for International Blood and Marrow Transplant Research (CIBMTR).

• Participant must be followed by a hematologist based in the US.

Locations
United States
California
UCSF Benioff Children's Hospitals
RECRUITING
Oakland
Stanford University
RECRUITING
Palo Alto
Minnesota
University of Minnesota
RECRUITING
Minneapolis
New York
Cohen Children's Medical Center
RECRUITING
New Hyde Park
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Texas Children's Hospital
RECRUITING
Houston
Contact Information
Primary
bluebird bio
clinicaltrials@bluebirdbio.com
+1-833-999-6378
Time Frame
Start Date: 2024-01-23
Estimated Completion Date: 2043-12
Participants
Target number of participants: 150
Treatments
All Participants
Participants with β-thalassemia treated with beti-cel in the post-marketing setting will be followed in this registry study for up to 15 years after infusion with beti-cel to collect real-world longitudinal data.
Sponsors
Collaborators: Center for International Blood and Marrow Transplant Research
Leads: Genetix Biotherapeutics Inc.

This content was sourced from clinicaltrials.gov