Q26-42: Cellular Therapy and HCT History

Question 26: Is this the first time the recipient is being treated using a cellular therapy?

Specify if the recipient ever had a prior cellular therapy, excluding DLIs. Include all cellular therapy infusions, except DLIs, in the recipient’s history, even if the infusions were not performed at the same center. The intent is to capture the full picture of the recipient’s treatment history.

*Prior cellular therapy reported to CIBMTR
If Unknown is selected for Were all prior cellular therapies reported to CIBMTR, 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 27: Were all prior cellular therapies (non-HCT) reported to the CIBMTR?

Indicate if all prior cellular therapies were reported to CIBMTR. This should include all cellular therapy infusions (except for DLIs) not performed at your center. If the recipient is a transfer recipient, reported past infusion dates can be found in the Recipient Information Grid in FormsNet3^SM.

Contact CIBMTR Customer Support if there are any questions.

Question 28: 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 Multiple Prior Cellular Therapies
Complete the Date of prior cellular therapy, Was the prior cellular therapy performed at a different institution, Specify the institution that performed the prior cellular therapy, Specify the primary indication for the prior cellular therapy, and What was the cell source for the prior cellular therapy questions to report all prior cellular therapies that have not yet been reported to CIBMTR by adding an additional instance in the FormsNet3^SM application.

Question 29: Date of the prior cellular therapy

Report the date of the prior cellular therapy being reported in this 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 30: 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.

Questions 31 – 32: Was the prior cellular therapy performed at a CIBMTR Affiliated Network Center?

Specify if the prior cellular therapy was performed at a CIBMTR Affiliated Network Center. If Yes, select the CIBMTR Center Number (CCN).

Question 33: Specify Non-CIBMTR Affiliated Network Center

Report the name, city, state, and country of the non-CIBMTR Affiliated Network Center where the recipient’s prior cellular therapy 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.

Questions 34 – 35: 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, leave the question blank and override the error as “not documented”.

Question 36: 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
If a prior HCT has already been reported in FormsNet3^SM, the HCT history section will be disabled to reduce the reporting burden.

Question 37: Has the recipient ever had a prior HCT?

Specify if the recipient ever had a prior HCT. Include all HCTs in the recipient’s history, even if the transplants were performed at different centers. The intent is to capture the full picture of the recipient’s treatment / transplant history.

Question 38: Specify the number of prior HCTs

Enter the number of prior HCTs for the recipient. An HCT event is defined as an infusion of mobilized peripheral blood stem cells (PBSC), bone marrow, or cord blood. For more information on how to distinguish infusion types [example: HCT versus donor cellular infusion (DCI)], see Appendix D: How to Distinguish Infusion Types.

Reporting Scenarios
For recipients who have received a previous HCT (prior to the HCT for which this form is being completed), the following are examples of how to calculate the number of prior HCTs.

• Example 1: A recipient was previously transplanted under a protocol that included an infusion of cells over multiple days: day 0, day +1 and day +2. This series of infusions is considered one HCT event (as opposed to three HCT events) and should be counted as HCT Event #1.
• Example 2: A recipient previously received an allogeneic HCT (HCT Event #1). Then, due to delayed neutrophil recovery, the recipient received additional cryopreserved allogeneic mobilized PBSC from the original donor, without a preparative regimen (i.e., “boost” – HCT Event #2). One prior HCT should be reported.
• Example 3: A recipient previously received an autologous HCT (HCT Event #1). Then due to delayed neutrophil recovery, the recipient received additional cryopreserved autologous cells without a preparative regimen (i.e., “boost” which is not counted as an HCT event because the intent of the autologous infusion is to treat the graft failure). The boost is successful, but a few years later the recipient develops a new malignancy. The recipient is scheduled to receive a subsequent autologous HCT with preparative regimen (HCT Event #2). One prior HCT should be reported.
  

*Prior HCTs reported to CIBMTR
If Unknown is selected for Were all prior HCTs reported to CIBMTR, then Date of prior HCT, Was the prior HCT performed at a different institution, Specify the institution that performed the last HCT, and What was 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 39: Were all prior HCTs reported to the CIBMTR?

Specify if all prior HCTs were reported to CIBMTR. This should include any / all HCTs not performed at this center. If the recipient is a transfer recipient, reported past HCT dates can be found in the Recipient Information Grid in FormsNet3^SM.

Contact CIBMTR Center Support if there are questions.

*Reporting Prior HCTs
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 HSC source for the prior HCT questions to report all prior HCTs that have not yet been reported to CIBMTR by adding an additional instance in the FormsNet3^SM application.

Question 40: Date of the prior HCT

Report the date of the prior HCT being reported in this 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.

Questions 41: 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 42 – 43: Was the prior HCT performed at a CIBMTR Affiliated Network Center?

Specify if the prior HCT was performed at a CIBMTR Affiliated Network Center. If Yes, select the CIBMTR Center Number (CCN).

Question 44: Specify Non-CIBMTR Affiliated Network Center

Report the name, city, state, and country of the non-CIBMTR Affiliated Network Center where the recipient’s prior HCT 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 45: Specify the HSC source(s) for the prior HCT (check all that apply)

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

• Autologous: Cells collected from the recipient for his / her own use.
• Allogeneic, unrelated: An unrelated donor who shares no known ancestry with the recipients. Include adoptive parents / children or stepparents / children.
• Allogeneic, related: A related donor who is a blood-related relative. This includes monozygotic (identical twins), non-monozygotic (dizygotic, fraternal, non-identical) twins, siblings, parents, aunts, uncles, children, cousins, half-sibling, etc.

Section Updates:

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