The recipient had a CAR-T infusion followed by an HCT. I see cell therapy forms with the HCT event date, is this correct?
What you are seeing is “combined follow-up”. The intent of “combined follow-up” (when a recipient receives both an HCT and genetically modified CT) is to collect both the HCT and CT outcomes data. To achieve this, instead of creating a new ‘universal form’, CIBMTR took the existing forms and combined, or paired them together, to create a “data package”. Instead of completing the HCT and CT forms according to different event dates and having staggered reporting periods, forms have now been combined under the most recent infusion, which is why you see the F4100s with the most recent event date.
The F4100s should cover the same reporting period as the associated F2450/2100s. The reporting periods are now counted from the HCT date. The contact date on the F4100 should match the F2450/2100, but the F4100 will capture the CT specific data that does not exist on the F2450/2100. For the sections of the forms that are the same, they are disabled on either the F2450/2100 or F4100.
There is an eLearning about combined follow-up available on the CIBMTR Portal. Log in and click on the tile for “Training &eLearnings.” The video eLearning is titled “Combined Follow-Up: HCT and Cellular Therapy”. This video is short and will describe the intent as well as show examples.
There is also a page in the Data Management Guide that has illustrations of different scenarios.
The recipient had a CAR-T infusion followed by an HCT. I see HCT forms with the cell therapy event date, is this correct?
What you are seeing is “combined follow-up”. The intent of “combined follow-up” (when a recipient receives both an HCT and genetically modified CT) is to collect both the HCT and CT outcomes data. To achieve this, instead of creating a new ‘universal form’, CIBMTR took the existing forms and combined, or paired them together, to create a “data package”. Instead of completing the HCT and CT form according to different event dates and having staggered reporting periods, forms have now been combined under the most recent infusion, which is why you see the F2450/2100 with the most recent event date.
The F2450/2100s should cover the same reporting period as the associated F4100. The reporting periods are now counted from the CT date. The contact date on the F2450/2100 should match the F4100, but the F2450/2100 will capture the HCT specific data that does not exist on the F4100. For the sections of the forms that are the same, they are disabled on either the F2450/2100 or F4100.
There is an eLearning about combined follow-up available on the CIBMTR Portal. Log in and click on the tile for “Training &eLearnings.” The eLearning is titled “Combined Follow-Up: HCT and Cellular Therapy”. This video is short and will describe the intent and show examples.
There is also a page in the Data Management Guide that has illustrations of different scenarios.
Can our center be set to TED track only for cell therapy?
TED/CRF level reporting for CT is not a center level attribute like HCT reporting. It is determined by your center’s reporting preference and infusion details. Each infusion will randomize separately.
Why have the follow-up forms not been removed after a death was reported?
Possibly a prior form was updated after the death was reported or a glitch occurred. First try and open the F4100 that reported the death and resubmit. The system should then remove the forms. Additionally, check to ensure that the date of death of the F2900 is the same as the date of contact on the F4100.
When can I create a new F2814 to report an infusion?
There are only 2 instances where a F2814 should be created.
- A new CRID reporting the first infusion
- An auto HCT where consent = No and there are no follow-up forms to report a subsequent infusion.
How do I report “bridging therapy”?
If a line of therapy starts before leukapheresis, but ends after leukapheresis, does it count as bridging therapy?
- No, bridging therapy is any new therapy that starts after leukapheresis. The intent is important as bridging therapy is meant to control a disease that is progressing while the product is being manufactured.
If a line of therapy contains both systemic and radiation therapy for which the systemic therapy starts before leukapheresis, but the radiation therapy starts after leukapheresis, does the radiation therapy count as bridging therapy while the systemic therapy does not, even though they are considered one line?
- If it was given to control the disease prior to infusion, then yes. If it was given for example in myeloma to alleviate pain, then no. The intent is important when determining if therapy is considered bridging.
In an opposite scenario, if a line of therapy contains both systemic and radiation therapy for which the radiation therapy starts before leukapheresis, but the systemic therapy starts after leukapheresis, does the systemic therapy count as bridging therapy, while the radiation therapy does not, even though they are considered being one line?
- Same as above.
Reporting bridging therapy on disease forms:
- Consolidation (if there was no prior relapse)
- Treatment for disease relapse (continuation of therapy for prior relapse)
- Maintenance (intrathecal chemo, but for ALL only and would be very rare)
Do I need to report a cell therapy infusion that was done at a different institution?
The subsequent CT should be reported on the appropriate follow-up form, which will make the F4000 come due. Your center is not responsible for reporting the CT done at a different center. You can attempt to transfer the CRID in FormsNet3SM. If the patient will continue to be seen at your center, the other center can then transfer the CRID back after reporting the CT. If the center rejects the transfer and will not be reporting on the CT, then you can submit a request to make the F4000 NRQ.
Instructions for initiating a transfer are found in the FormsNet3SM Training Guide
When I attempt to change the disease form status to LTF/SUR it gives me an error message “Access not allowed.”
First try making the F4100 LTF. The disease form status will automatically change when the F4100 is made LTF/SUR.