Subsequent Infusions and Contact Dates

If the recipient has a subsequent infusion (HCT or cellular therapy), the date of contact will depend on the type of subsequent infusion.

• Subsequent HCT or genetically modified cellular therapy (i.e., CAR-T)
  • Report the date of contact as the day before the preparative regimen / systemic therapy begins for the subsequent infusion. If no preparative regimen / lymphodepleting therapy is given, report the date of contact as the day before the subsequent infusion.
  • In these cases, actual contact on that day is not required, and the day prior to the initiation of the preparative regimen (or infusion if no preparative regimen / lymphodepleting therapy) should be reported. This allows every day to be covered by a reporting period but prevents overlap between infusion events. This is an exception to the standard date of follow-up reporting to ensure all dates are captured within the sequence of forms.

*Subsequent Cellular Therapies
For a subsequent cellular therapy, if the Cellular Therapy Essential Data Pre-Infusion (4000) is requested via CIBMTR Center Support to be made “NRQ”, then the date of contact should be appropriate to the reporting period .

• Subsequent non-genetically modified cellular therapy infusion (i.e., DLI, other DCI)
  • Report the date of contact as appropriate to the reporting period.

Review the examples below for additional information and examples regarding subsequent infusions:

Transplant and Gene Therapy Scenarios

*New Forms Due for Subsequent Infusions
For all subsequent infusions (transplant, gene therapy, cellular therapy), a new Pre-TED (2400) and Disease Classification (2402) or Cellular Therapy Essential Data Pre-Infusion (4000) Forms will come due, along with the appropriate post-infusion forms. If the subsequent infusion is a DLI, only the Donor Lymphocyte Infusion (2199) Form will come due.

*Subsequent Infusions: Gene Therapy
Gene therapy infusions are reported on HCT forms and follow the same rules.

Example 1: The recipient had a subsequent transplant with a preparative regimen.

• The recipient has their first transplant on 1/1/2021 and a planned second transplant on 2/1/2021. The recipient was admitted and received their first dose of chemotherapy for the preparative regimen for HCT #2 on 1/28/2021.
  • Report the Day 100 contact date 1/27/2021, regardless of actual contact on that date.

Example 2: The recipient had a subsequent transplant without a preparative regimen.

• Following their first transplant on 1/1/2021, a recipient with SCID required a subsequent allogeneic transplant due to poor graft function. The recipient has remained inpatient following the first transplant. The physician planned the second transplant for 5/31/2021 and proceeded without a preparative regimen.
  • Report the Day 100 contact date as 4/11/2021 (this date is + / – 15 days of the Day 100 anniversary date)
  • Report the six-month contact date as 5/30/2021.

Example 3: The recipient had a subsequent auto transplant for graft failure.

• The recipient has their first transplant on 3/1/2023 and a subsequent auto transplant for the indication of graft failure/insufficient hematopoietic recovery on 4/15/2023.
  • Report the Day 100 contact date as the appropriate date for the reporting period since a new Pre-TED (2400) / Disease Classification (2402) is not required for auto rescues.

Example 4: The recipient had a subsequent gene therapy with a preparative regimen.

• The recipient has their first transplant on 10/1/2023 and received a gene therapy infusion on 12/2/2023. The recipient was admitted and received their first dose of chemotherapy for the preparative regimen for the gene therapy on 11/29/203.
  • Report the Day 100 contact date 11/28/2023, regardless of actual contact on that date.

*Subsequent Cellular Therapies
For a subsequent cellular therapy, if the Cellular Therapy Essential Data Pre-Infusion (4000) is requested via CIBMTR Center Support to be made “NRQ”, then the date of contact should be appropriate to the reporting period

Example 5: The recipient had a subsequent genetically modified cellular therapy with lymphodepleting therapy administered prior to infusion.

• The recipient has their first transplant on 3/1/2022 and a genetically modified (e.g. CAR-T) cellular therapy infusion on 4/1/2022. The recipient was admitted and received their first dose of lymphodepleting therapy on 3/28/2022.
  • Report the Day 100 contact date as 3/27/2022 (regardless of actual contact on that date). Both HCT and CTED forms will be completed simultaneously, but all applicable HCT follow-up forms will be reset to the new event date (i.e., Forms 4100+2450 or Forms 4100+2100). See Subsequent Infusions – Updates to Follow-Up Reporting in the Data Management Manual for more information on combined follow up.

Example 6: The recipient had a subsequent genetically modified cellular therapy without lymphodepleting therapy administered prior to infusion.

• The recipient has their first transplant on 3/1/2022 and a genetically modified (e.g. CAR-T) cellular therapy infusion on 4/1/2022. The recipient was admitted and did not receive lymphodepleting therapy prior to infusion.
  • Report the Day 100 contact date as 3/31/2022 (regardless of actual contact on that date). Both HCT and CTED forms will be completed simultaneously, but all applicable HCT follow-up forms will be reset to the new event date (i.e., Forms 4100+2450 or Forms 4100+2100). See Subsequent Infusions – Updates to Follow-Up Reporting in the Data Management Manual for more information on combined follow up.

Example 7: The recipient had a subsequent non-genetically modified cellular therapy.

• The recipient has their first transplant on 1/21/23 and a non-genetically modified cellular therapy infusion on 2/15/23. Lymphodepleting therapy may or may not be given and does not affect the contact date.
  • Report the Day 100 contact date a date appropriate to the reporting period. Unlike example 5 & 6, combined follow-up will not be applied. HCT reporting continues uninterrupted.

*On Demand DLI Reporting
DLIs can be reported prior to the Post-TED (2450) or Post-Infusion follow up (2100) Form due date by creating a Indication for CIBMTR Data Reporting (2814) Form on demand.
When the Post-TED (2450) or Post-Infusion follow up (2100) form is completed at the due date, and no other infusions were given in the reporting period, report the DLI as a subsequent infusion, which will create a new Indication for CIBMTR Data Reporting (2814) Form. Submit a ticket via CIBMTR Center Support to request the form be made NRQ.

Example 8: The recipient had a subsequent Donor Lymphocyte Infusion (DLI).

• The recipient has their first transplant on 1/21/22 and receives a DLI on 2/27/2022. Lymphodepleting therapy may or may not be given and does not affect the contact date.
  • Report the Day 100 contact date as a date appropriate to the reporting period. A DLI (2199) form should be completed for each DLI received in the reporting period.
  • The Post-TED (2450) or Post-Infusion follow up (2100) form should not be completed early to report a DLI.

Cellular Therapy Scenarios

*New Forms Due for Subsequent Infusions
For all subsequent infusions (transplant, gene therapy, cellular therapy), a new Pre-TED (2400) and Disease Classification (2402) or Cellular Therapy Essential Data Pre-Infusion (4000) Forms will come due, along with the appropriate post-infusion forms. If the subsequent infusion is a DLI, only the Donor Lymphocyte Infusion (2199) Form will come due.

Example 9: The recipient had a subsequent cellular therapy with lymphodepleting therapy administered prior to infusion.

• The recipient has their first cellular therapy infusion on 1/21/23 and a subsequent cellular therapy infusion on 2/15/2023. The recipient was admitted and received their first dose of lymphodepleting therapy on 2/12/2023.
  • Report the Day 100 contact date as 2/11/2023 (regardless of actual contact on that date).

Example 10: The recipient had a subsequent cellular therapy without lymphodepleting therapy administered prior to infusion.

• The recipient has their first transplant on 1/21/23 and subsequent cellular therapy infusion on 2/15/23. The recipient was admitted and did not receive lymphodepleting therapy.
  • Report the Day 100 contact date 2/14/23, regardless of actual contact on that date.

Example 11: The recipient receives a subsequent HCT with a preparative regimen after a genetically modified cellular therapy.

• The recipient had a cellular therapy on 1/1/2020 and was seen regularly through the first 100 days. The recipient was admitted and received their first dose of chemotherapy for the preparative regimen for the HCT on 1/28/2020.
  • Report the Day 100 contact date as 1/27/2022 (regardless of actual contact on that date). Both HCT and CTED follow up forms will be completed simultaneously, but all applicable cellular therapy follow-up forms will be reset to the new event date (i.e., Forms 2450+4100 or Forms 2100+4100). The forms will then have the same event date and due date. See Subsequent Infusions – Updates to Follow-Up Reporting in the Data Management Manual for more information on combined follow up.

Example 12: The recipient receives a subsequent HCT without a preparative regimen after a genetically modified cellular therapy.

• The recipient had a cellular therapy on 1/1/2020 and was seen regularly through the first 100 days. The recipient was admitted and proceeded without a preparative regimen for the HCT on 1/28/2020.
  • Report the Day 100 contact date as 1/27/2022 (regardless of actual contact on that date). Both HCT and CTED follow up forms will be completed simultaneously, but all applicable cellular therapy follow-up forms will be reset to the new event date (i.e., Forms 2450+4100 or Forms 2100+4100). The forms will then have the same event date and due date. See Subsequent Infusions – Updates to Follow-Up Reporting in the Data Management Manual for more information on combined follow up.

Example 13: The recipient receives a subsequent HCT with a preparative regimen after a non-genetically modified cellular therapy.

• The recipient had a cellular therapy on 1/1/2022 and was seen regularly through the first 100 days. The recipient was admitted and received their first dose of chemotherapy for the preparative regimen for the HCT on 1/28/2022.
  • Report the Day 100 contact date as 1/27/2022 (regardless of actual contact on that date).

Example 14: The recipient receives a subsequent HCT without a preparative regimen after a non-genetically modified cellular therapy.

• The recipient had a cellular therapy on 1/1/18 and was seen regularly through the first 100 days. The physician planned the subsequent transplant for 2/15/2018 and proceeded without a preparative regimen
  • Report the Day 100 contact date as 2/14/2018 (regardless of actual contact on that date). Reporting on the cellular therapy event will end.

Example 15: The recipient receives a subsequent gene therapy with a preparative regimen after a genetically modified cellular therapy.

• The recipient had a cellular therapy on 1/1/18 and was seen regularly through the first 100 days. The recipient was admitted and received their first dose of chemotherapy for the preparative regimen for the gene therapy on 1/28/2018.
  • Report the Day 100 contact date as 1/27/2022 (regardless of actual contact on that date).

Section Updates:

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