Q18-32: Cellular Therapy and HCT History

Question 18: Is this the first time the recipient is being treated using a cellular therapy (non-HCT)?

This is defined as the first application of a cellular therapy the recipient ever receives, not the first application the recipient receives at your facility. The intent is to capture the full picture of the recipient’s treatment history.

*Prior cellular therapy reported to the CIBMTR
If Unknown is selected for Were all prior cellular therapies reported to the CIBMTR, then Date of the prior cellular therapy, Was the cellular therapy performed at a different institution, Specify the institution that performed the cellular therapy, and Specify the source(s) for the prior cellular therapy questions can be answered to report information regarding prior cellular therapies; however, these questions are not required to be completed.

Question 19: Were all prior cellular therapies (non-HCT) reported to the CIBMTR?

This should include all cellular therapy infusions (except for DLIs) not performed at your center. If the recipient is a transfer patient, you will be able to see all past infusion dates in the Recipient Information Grid in FormsNet3^SM. Contact the CIBMTR Customer Support if there are questions.

If Yes, all prior cellular therapies were reported to the CIBMTR or Unknown, continue with the Donor Information section.

Question 20: Specify the number of prior cellular therapies:

Enter the number of prior cellular therapies for the recipient. A “cellular therapy event” is defined as the infusion or administration of a cellular therapy product for treatment of a specific indication(s). Each infusion or administration of a cellular product should be counted separately. Include all infusions the recipient received, even if they were not performed at your center. The intent is to capture the full picture of the recipient’s treatment history. It is not expected to complete forms for prior unreported infusions.

*Reporting Prior Cellular Therapies
FormsNet3^SM application: Complete the Date of the prior cellular therapy, Was the cellular therapy performed at a different institution, Specify the institution that performed the cellular therapy, and Specify the source(s) for the prior cellular therapy questions to report all prior cellular therapies that have not yet been reported to the CIBMTR by adding an additional instance in the FormsNet3^SM application.
Paper form submission: Copy the Date of the prior cellular therapy, Was the cellular therapy performed at a different institution, Specify the institution that performed the cellular therapy, and Specify the source(s) for the prior cellular therapy questions and complete for prior cellular therapy that has not yet been reported to the CIBMTR

Question 21: Date of the prior cellular therapy:

Report the date (YYYY-MM-DD) of the prior cellular therapy for the reported instance. If the exact date is unknown and must be estimated, check the “date estimated” box.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 22: Was the cellular therapy performed at a different institution?

Indicate if the prior cellular therapy being reported in this instance was performed at another institution. If the prior cellular therapy was not performed at a different institution, select No.

Question 23: Specify the institution that performed the prior cellular therapy:

Report the name, city, state, and country of the institution where the recipient’s prior cellular therapy being reported in this instance was performed. These data are used to identify and link the recipient’s existence in the database and, if necessary, obtain data from the other institution where the previous treatment was administered.

Question 24 – 25: Specify the primary indication for the prior cellular therapy:

Select the indication for the prior cellular therapy reported in this instance. Any indication that is followed by “(post-HCT)” or “(with HCT)” requires a prior HCT also be reported to CIBMTR.

If the indication for the prior cellular therapy is not listed, select Other indication and specify the indication. If the indication for the prior cellular therapy is not documented, select Unknown.

Question 26: What was the cell source for the prior cellular therapy? (check all that apply)

Indicate the cell source(s) for the prior cellular therapy reported in this instance. If the product is “off the shelf” or a “third party donor” product obtained from pharmaceutical companies or other corporate entities, the donor type should still be identified.

An Autologous product has cells collected from the recipient for his / her own use.

An unrelated donor (Allogeneic, unrelated) is a donor who shares no known ancestry with the recipient. Include adoptive parents / children or stepparents / children.

A related donor (Allogeneic, related or syngeneic) is a blood-related relative. This includes monozygotic (identical twins), non-monozygotic (dizygotic, fraternal, non-identical) twins, siblings, parents, aunts, uncles, children, cousins, half-siblings, etc.

*HCT History
When both HCT and CT forms are submitted, duplicate questions will exist between the Pre-TED (2400) form and Pre-CTE (4000) form. To reduce the reporting burden, duplicated questions, including HCT history, on the Cell Therapy forms are disabled.

Question 27: Has the recipient ever had a prior HCT?

Include all HCTs in the recipient’s history, even if the transplants were not performed at your center. The intent is to capture the full picture of the recipient’s treatment history.

If the recipient never had a prior HCT, report No.

*Prior HCTs reported to the CIBMTR
If Unknown is selected for Were all prior HCTs reported to the CIBMTR, Date of prior HCT, Was the prior HCT performed at a different institution, Specify the institution that performed the last HCT, and Specify the HPC source for the prior HCT questions can still be answered to report information regarding prior HCTs; however, these questions are not required to be completed.

Question 28: Were all prior HCTs reported to the CIBMTR?

This should include any / all HCTs not performed at your center. If the recipient is a transfer patient, you will be able to see all past HCT dates in the Recipient Information Grid in FormsNet3^SM. Contact CIBMTR Customer Support if there are questions.

If Yes or Unknown, continue with Are any of the products, associated with this course of cellular therapy, genetically modified.
p(banner tip). Reporting Prior HCTs

FormsNet3^SM application: Complete the Date of prior HCT, Was the prior HCT performed at a different institution, Specify the institution that performed the last HCT, and Specify the HPC source for the prior HCT questions to report all prior HCTs that have not yet been reported to the CIBMTR by adding an additional instance in the FormsNet3^SMSM application.
Paper form submission: Copy the Date of prior HCT, Was the prior HCT performed at a different institution, Specify the institution that performed the last HCT, and Specify the HPC source for the prior HCT questions and complete for the prior HCT that has not yet been reported to the CIBMTR.

Question 29: Date of the prior HCT:

Report the date (YYYY-MM-DD) of the prior HCT reported in this instance.

If the exact date is unknown, please view General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

Questions 30: Was the HCT performed at a different institution?

Indicate if the prior HCT being reported in this instance was performed at another institution. If the prior HCT was not performed at a different institution, select No.

Questions 31: Specify the institution that performed the HCT

Report the name, city, state, and country of the institution where the recipient’s prior HCT being reported in this instance was performed. These data are used to identify and link the recipient’s existence in the database and, if necessary, obtain data from the other institution where the previous infusion was administered

Question 32: Specify the HSC source(s) for the prior HCT: (check all that apply)

Indicate the applicable cell source(s) for the prior HCT being reported in this instance.

An Autologous product has cells collected from the recipient for his/her own use.

An unrelated donor (Allogeneic, unrelated) is a donor who shares no known ancestry with the recipient. Include adoptive parents / children or stepparents / children.

A related donor (Allogeneic, related) is a blood-related relative. This includes monozygotic (identical twins), non-monozygotic (dizygotic, fraternal, non-identical) twins, siblings, parents, aunts, uncles, children, cousins, half-siblings, etc.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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