Q4 – 6: Initial ANC Recovery

!Initial ANC Recovery
The Initial ANC Recovery questions can only be completed on the Day 100, six-month, one-year, and two-year follow-up forms. These questions will be skipped for all subsequent reporting periods. Did late graft failure occurr must be answered on all follow-up forms.

*Initial ANC Recovery
Recovery, as reported in this section, does not distinguish between allogeneic engraftment (blood and stem cells of donor origin) and autologous engraftment (blood and stem cells of host origin). To demonstrate engraftment for allogeneic recipients, particularly non-myeloablative or reduced intensity approaches, chimerism tests must be done. These measure the quantity of donor cells relative to the quantity of host (recipient) cells. While ANC usually represents donor cells in allogeneic HCT, it cannot be proven without chimerism studies.

*Combined Follow-Up
In scenarios where a cell therapy was given after an HCT and this form is now being completed based on the subsequent cell therapy date, these questions do not apply and are disabled.

*ANC / Platelet Recovery Reporting Overview
Refer to the ANC / Platelet Recovery reporting overview for information on reporting ANC recovery.

*Not Applicable and Previously Reported
When Not applicable is reported for the Day 100 reporting period, select Previously reported for all future reporting periods.

Question 4: Was there evidence of initial hematopoietic recovery?

Specify if there was evidence of initial ANC recovery following this infusion, using the following guidelines:

• Yes: ANC ≥ 500/mm³ (or ≥ 0.5 × 10⁹/L) achieved and sustained for three laboratory values.
• No: ANC ≥ 500/mm³ (or ≥ 0.5 × 10⁹/L) was not achieved
• Not applicable: The ANC never dropped below 500/mm³ (or ≥ 0.5 × 10⁹/L) at any time post-infusion. This option is only applicable for the Day 100 reporting period.
• Previously reported: This is the six-month or annual follow-up, and the initial ANC recovery has already been reported on a previous form.

Question 5: Date ANC ≥ 500/mm³ (first of 3 lab values)

Report the first date of the three consecutive laboratory values obtained on different days where the ANC was ≥ 500/mm³ (or ≥ 0.5 × 10⁹/L). For an example of tracking ANC recovery, see the Tracking ANC Recovery in the ANC / Platelet Recovery reporting instruction overview.

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

*Combined Follow Up and Secondary Graft Failure
In scenarios where a cellular therapy was given after an HCT and this form is now being completed based on the subsequent cellular therapy date, Did secondary graft failure occur? still applies and should be answered.

Question 6: Did secondary graft failure occur?

Secondary graft failure is defined when the recipient meets criteria for initial engraftment but subsequently develops loss of a previously functioning graft by development of at least two lines of cytopenia. Secondary graft failure is more often associated with allogeneic HCT than with autologous HCT. Some possible causes for late graft failure include graft rejection related to residual host immunity, persistent or progressive disease, low donor cell yield, medication side-effect, infection or GVHD.¹

If the recipient meets the criteria of secondary graft failure, check Yes. If it is unclear secondary graft failure occurred, seek clinician clarification.

¹ Appelbaum, F. R., & Thomas, E. D. (2009). Thomas’ Hematopoietic Cell Transplantation: Stem Cell Transplantation (4th ed.). Chichester, UK: Wiley-Blackwell.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
Q6	1/23/2026	Add	Combined Follow Up and Secondary Graft Failure blue box added: Combined Follow Up and Secondary Graft Failure: In scenarios where a cellular therapy was given after an HCT and this form is now being completed based on the subsequent cellular therapy date, Did secondary graft failure occur? still applies and should be answered.	Added for clarification

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