This is a summary of the elearning Cellular Therapy Forms Submission: How Forms Come Due. It provides an overview of how the CIBMTR cell therapy data collection forms come due, and a description of the reporting schedules.
There are three scenarios for how cell therapy forms come due:
Cell Therapy, Stand Alone (No HCT Forms)
Cell therapy infusions given without a prior HCT are also known as “stand alone” infusions. These recipients have no existing CRID and are registered for the first time with CIBMTR for the cell therapy infusion. Please review CIBMTR Guidance Document for Reporting Autologous Cell Therapies to determine if the cell therapy should be reported to CIBMTR.
Once a CRID is assigned in FormsNet3, an Indication for CIBMTR Data Reporting Form 2814 will be made due. After the Indication Form is complete, reporting the indication as a cell therapy triggers the Pre-CTED Form 4000. Upon completion of the Pre-CTED, the required number of Product Form(s) 4003, Infusion Form(s) 4006, Post-CTEDs Form(s) 4100, and any other disease or infection forms are added based upon the indication and product information reported.
Co-Infusion (with HCT)
A co-infusion is always given with an HCT, between the start date of the preparative regimen and up to, or on, day 0 of the HCT. The intent of a co-infusion is something other than to restore hematopoiesis, such as ‘infection prophylaxis’, ‘to promote engraftment’, or ‘GVHD prophylaxis’. Please see Appendix D: How to Distinguish Infusion Types for a definition of co-infusion.
Reporting of a co-infusion is done on the Pre-TED Form 2400. When completing the donor section on Form 2400, indicate the number of products from the donor. This is the total number of products regardless of the intent of the products. Then report the number of products intended to engraft in the following question. The numbers reported in these two questions will ensure the correct number of HCT Infusion Form(s) 2006, and Cellular Therapy Product Form(s) 4003 are made due.
For example, if a donor gave 2 products, one intended for engraftment, as well as additional cells to be given for GVHD prophylaxis, you would answer number of products as “2” and products for engraftment as “1”. The product intended for engraftment will generate a Form 2006. The remaining product will generate a Form 4003. Completion of the Product Form 4003 will make due the appropriate number of Infusion Form 4006.
No follow-up reporting of the co-infusion on form 4100 is required.
Post-HCT Cell Therapy
When a recipient receives a cell therapy after HCT, the cell therapy infusion will be reported on the appropriate HCT follow-up form. This will make the Indication for CIBMTR Data Reporting Form 2814 come due. Completing the indication form will trigger the Form 4000 to come due.
Once the Form 4000 is completed, the required number of cell therapy product forms, infusion forms, and Post-CTEDs will come due.
There are differences in the number of Form 4100s required, and the follow-up schedule, based on whether the cell therapy product is genetically modified or not.
When a recipient receives a genetically modified cell therapy product after HCT, there is a need to continue to capture both HCT and CT outcomes. Please see the Combined Follow-Up section for more information.
As of the Summer 2020 release, CIBMTR implemented new functionality to reduce center reporting burden and redundancies when having to report multiple cell therapy and HCT events for a single patient. This process is known as “combined follow-up”.
All applicable follow-up forms will be aligned under the same event date at the appropriate timepoints (i.e. Forms 2450+4100 or 2100+4100). Custom enabling and disabling of duplicate questions will streamline follow-up reporting when a recipient receives infusions for multiple indications with overlapping time periods.
Post-HCT cell therapy falls into two categories, which affect how forms come due:
- Recipient receives a non-genetically modified cell therapy product
- Recipient receives a genetically modified cell therapy product
Non-Genetically Modified
When a recipient receives a non-genetically modified cell therapy product after HCT, the cell therapy infusion will be reported on the appropriate HCT follow-up form. This will make the Indication for CIBMTR Data Reporting Form 2814 come due. Completing the indication form will trigger the Form 4000 to come due.
Once the Form 4000 is completed, the required number of cellular therapy product forms, infusion forms, and a single Post-CTED will come due. HCT follow-up reporting will continue.
Genetically Modified
When a recipient receives a genetically modified cell therapy product after HCT, there is a need to continue to capture both HCT and CT outcomes. As of the Summer 2020 release, CIBMTR implemented new functionality to reduce center reporting burden and redundancies when having to report multiple cell therapy and HCT events for a single patient. This process is known as “combined follow-up”.
All applicable follow-up forms will be aligned under the same event date at the appropriate timepoints (i.e. Forms 2450+4100 or 2100+4100). Custom enabling and disabling of duplicate questions will streamline follow-up reporting when a recipient receives infusions for multiple indications with overlapping time periods.