Summary

Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Beta-Thalassemia, Thalassemia

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • There are no exclusion criteria for Registry participation.

Locations

  • UCSF Benioff Children's Hospitals accepting new patients
    Oakland California 94609 United States
  • Texas Children's Hospital accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
bluebird bio
ID
NCT06271512
Study Type
Observational [Patient Registry]
Participants
Expecting 150 study participants
Last Updated