The Betibeglogene Autotemcel (Zynteglo®) Pre-Infusion Supplemental Data Collection (2544) Form must be completed for recipients who are enrolled onto CIBMTR study CS22-24. This is a post-marketing prospective, multicenter, observational, long-term safety and effectiveness registry study of recipients with beta-thalassemia treated with betibeglogene autotemcel (beti-cel).
The Pre-Transplant Essential Data (2400) Form will confirm study eligibility, this includes event date and gene therapy product infused. Once eligibility is confirmed, the Betibeglogene Autotemcel (Zynteglo®) Pre-Infusion Supplemental Data Collection (2544) Form will come due for all recipients along with the Recipient Baseline (2000), Gene Therapy Product (2003) and Thalassemia Pre-Infusion (2058) Forms.
Links to Sections of Form:
Q1: Hypertransfusions
Q2-5: Splenic Assessments
Q6-10: Transfusion Therapy
Q11: Mobilization
Q12-13: Additional Iron Overload Assessments
Q14-17: Additional Hematologic Labs
Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.
If you need to reference the historical Manual Change History for this form, you can reference the retired manual section on the Retired Forms Manuals webpage.
Date | Manual Section | Add/Remove/Modify | Description |
---|---|---|---|
9/27/2024 | Betibeglogene Autotemcel (Zynteglo®) Pre-Infusion Supplemental Data | Add | Version 1 of the Betibeglogene Autotemcel (Zynteglo®) Pre-Infusion Supplemental Data section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2544. |
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