The Betibeglogene Autotemcel (Zynteglo®) Post-Infusion Supplemental Data Collection (2545) 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.
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®) Post-Infusion Supplemental Data Collection (2545) Form will come due with the Post-Infusion Data (2100) and Thalassemia Post- Infusion (2158) Forms for each follow up timepoint, 100 days through 15 years annually, per FDA Gene Therapy Long Term Follow Up Guidelines.
Links to Sections of Form:
Q1-2 Recipient Information
Q3-12 Growth Factor and Cytokine Therapy
Q13-15 Splenic Assessments
Q16: Additional Iron Overload Assessments
Q17-20 Additional Hematologic Labs
Q21-23 Disease Modifying Therapies
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®) Post-Infusion Supplemental Data | Add | Version 1 of the Betibeglogene Autotemcel (Zynteglo®) Post-Infusion Supplemental Data section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2545. |
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