Q13 – 15: Initial ANC Recovery

!Initial ANC Recovery
The Initial ANC Recovery questions can only be completed on the 100-day, 6-month, 1 year, and 2 year follow-up forms. These questions will be skipped for all subsequent reporting periods. Question 16 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 cellular therapy was given after an HCT and this form is now being completed based on the subsequent cellular therapy date, these questions do not apply and are disabled.

ANC recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 × 10⁹/L (500/mm³) for three consecutive laboratory values obtained on different days. Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is ≥ 0.5 × 10⁹/L. At some institutions, the laboratory reports display the ANC value once there are sufficient white blood cells to perform a differential count. At other institutions, the laboratory reports do not display the ANC, and it must be calculated from the white blood cell count (WBC) and the percent of segmented and band neutrophils (if the differential was performed on a machine, the percent neutrophils will include both segmented and band neutrophils). If the laboratory report displays an automated ANC value of exactly 0.5, the actual ANC value should be calculated from the manual differential if available. The calculated value from the manual differential will determine ANC recovery. If your institution’s laboratory reports do not display the ANC value, use the following calculation to determine the ANC:

Calculating Absolute Neutrophil Count (ANC)¹

¹ Traditionally, the definition of ANC recovery required selecting the first date of three consecutive days in which the recipient’s ANC was ≥ 0.5×10⁹/L (500/mm³). For various reasons it may not be possible to obtain daily laboratory values. Under those circumstances, report ANC recovery based upon three consecutive laboratory values (drawn more than a day apart) as long as the ANC remains ≥ 0.5×10⁹/L (500/mm³).

Tracking the date of ANC recovery may not always be straightforward. In some cases the ANC may fluctuate for a period of time before the recipient fully recovers. In other cases the ANC may remain above 0.5 × 10⁹/L for several days immediately post-HCT and then fall below 0.5 ×10⁹/L. Do not begin counting ANC values of ≥ 0.5 × 10⁹/L towards recovery until the ANC has dropped to the lowest level (nadir) post-HCT. If the recipient was transplanted using a non-myeloablative (NST) or reduced intensity (RIC) regimen, or was transplanted for an immunodeficiency (e.g., SCID, WAS), the recipient’s ANC may never drop below 0.5 × 10⁹/L. If this is the case, an ANC recovery date will not be reported, and the “never below” option should be chosen. However, if the recipient’s ANC drops below 0.5×10⁹/L for even one day, this should be considered the nadir and “never below” should not be chosen. See the following example for more information regarding tracking the date of ANC recovery.

Tracking ANC Recovery

Transplant Date = May 6

Date	WBC	%Neutrophils	ANC
May 7	900	0.6	540
May 8	850	0.59	502
May 9	720	0.7	504
May 10	300	0.45	135
May 11	15	No differential	—
May 12	30	No differential	—
May 13	50	No differential	—
May 14	250	0.4	100
May 15	800	0.7	560	Date of first recovery: ANC ≥ 0.5×109/L
May 16	1050	0.8	840
May 17	1000	0.7	700
May 18	1800	0.6	1080
May 19	2000	0.55	1100
May 20	2500	0.53	1325
May 21	2250	0.43	968
May 22	1500	0.45	675

Question 13: Was there evidence of initial hematopoietic recovery?

Indicate whether or not there was evidence of initial ANC recovery following this HCT.

Check only one response:

• If Yes if ANC ≥ 500/mm³ (or ≥ 0.5 × 10⁹/L) achieved and sustained for 3 laboratory values.
• If No if ANC ≥ 500/mm³ (or ≥ 0.5 × 10⁹/L) was not achieved.
• Check Not applicable if the recipient’s ANC never dropped below 0.5 × 10⁹/L at any time post-HCT. This option is only applicable in the 100-day reporting period.
• Check Previously reported if this is the 6-month or annual follow-up, and the initial ANC recovery has already been reported. .

*When Not applicable is reported for 100-day reporting period, for all future reporting periods, select Previously reported.

Question 14: Date ANC ≥ 500/mm³ (first of 3 lab values)

Enter 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 example above.

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

Question 15: Did late graft failure occur?

Late (or 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. Late 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.²

If the recipient meets the criteria of graft failure, check Yes.

² 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)
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