RECRUITING

A Study of Participants with Β-Thalassemia Treated with Betibeglogene Autotemcel

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-01-23
Study Completion:2043-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06271512

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be treated with beti-cel in the post marketing setting at a center in the US that participates in the Registry.
  2. * Participant must sign an informed consent and/or assent prior to enrollment as required under applicable laws and regulations.
  3. * 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).
  4. * Participant must be followed by a hematologist based in the US.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

bluebird bio
CONTACT
+1-833-999-6378
clinicaltrials@bluebirdbio.com

Principal Investigator

Himal Lal Thakar, MD
STUDY_DIRECTOR
bluebird bio, Inc.

Study Locations (Sites)

UCSF Benioff Children's Hospitals
Oakland, California, 94609
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Cohen Children's Medical Center
New Hyde Park, New York, 11040
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: bluebird bio

  • Himal Lal Thakar, MD, STUDY_DIRECTOR, bluebird bio, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-23
Study Completion Date2043-12

Study Record Updates

Study Start Date2024-01-23
Study Completion Date2043-12

Terms related to this study

Additional Relevant MeSH Terms

  • Beta-Thalassemia