The reporting of peripheral blood count recoveries on the F4100 has a different intent than the F2450/2100. Systemic therapy (such as lymphodepleting therapy given prior to a CAR-T infusion) may negatively impact ANC and platelet counts. The intent of the questions on the F4100 is to determine cell count recovery post systemic therapy, not as a measure of engraftment.
Question 12: Was there evidence of initial recovery?
Absolute neutrophil recovery (ANC) recovery is defined as an ANC of ≥ 500/mm3 (or ≥ 0.5 × 109/L) 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 ≥ 500/mm3. 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).The percent neutrophils (if the differential was performed on an instrument, will include both segmented and band neutrophils. If the laboratory report displays an automated ANC value of exactly 500/mm3, 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:
Example 1: Calculating Absolute Neutrophil Count (ANC)
Traditionally, the definition of ANC recovery required the selection of 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 ≥ 500/mm3 for several days immediately post-HCT and then fall below ≥ 500/mm3. Do not begin counting ANC values of ≥ 500/mm3 towards recovery until the ANC has dropped to the lowest level (nadir) post- infusion. See the following example for more information regarding tracking the date of ANC recovery.
To report dates in this question, use the first of 3 consecutive laboratory values obtained on different days.
Example 2: Tracking ANC Recovery
Infusion Date = May 6
Contact Date = August 15
|May 11||15||No differential||—|
|May 12||30||No differential||—|
|May 13||50||No differential||—|
|May 15||800||0.7||560||Date of initial recovery: ANC ≥ 500/mm3 (report this date in question 15)|
|May 21-August 14||—||—||—||ANC ≥ 500/mm3 for timeframe|
|August 15 (contact date)||2250||0.43||968|
Check only one response:
• If “yes,” continue with question 13
• If “no,” continue with question 14
• Check “not applicable,” if the recipient’s ANC never dropped below 500/mm3 (or ≥ 0.5 × 109/L). at any time post- cellular therapy infusion, continue with question 16.
• Check “previously reported” if this is the 6 month or annual follow-up, and ANC initial recovery has already been reported on a previous form. Continue with question 16.
Question 13: 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, see Example 2 above.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Question 14: Was an initial platelet count > 20 × 109/L achieved?
This question is not applicable to all cellular therapies. Some cellular therapies require a course of chemotherapy prior to the infusion, such as in the case of chimeric antigen receptor (CAR) T-cells. One of the described toxicities is the inability for hematologic recovery, either by an added cycle of chemotherapy in a recipient who received many prior lines of chemotherapy or by a direct toxicity from the cellular therapy. If the recipient’s platelet count never dropped, there is no need to answer further.
The following questions refer to initial platelet recovery following the cellular therapy infusion for which this form is being completed. All dates should reflect no platelet transfusions administered for seven consecutive days. Report the date of the first of three consecutive laboratory values ≥ 20 × 109/L obtained on different days, as shown in Example 1 below. Note that platelet recovery may take place well after the recipient has returned to the referring physician for care. It is essential that information and laboratory values be obtained from the referring physician.
Transfusions temporarily increase platelet counts. When the data is later used for analysis, it is important to be able to distinguish between a recipient whose body was creating the platelets on its own and a recipient who required transfusions to support the counts.
The following example illustrates the procedure to follow for reporting platelet recovery.
Example 1. Reporting Platelet Recovery
This question relates to initial platelet recovery. Dates should not reflect transfusions that took place 7 days prior to the date that it listed. To report dates in this question, use the first of 3 consecutive laboratory values obtained on different days.
Indicate whether or not there was evidence of initial platelet recovery following this cellular therapy infusion.
Check only one response:
- If “yes,” continue with question 15.
- If “no,” continue with question 16.
- Check “not applicable,” if the recipient’s platelets never dropped below 20 × 109/L at any time post-cellular therapy infusion and a platelet transfusion was never required. If the recipient’s platelet count drops below 20 × 109/L and/or the recipient received a platelet transfusion even once, do not use this option. This option is only applicable in the 100 day reporting period. Continue with question 16.
- Check “previously reported” if this is the 6 month or annual follow-up, and initial platelet recovery has already been reported on a previous form. Continue with question 16.
Question 15: Date platelets > 20 × 109/L:
Enter the first date of three consecutive laboratory values obtained on different days where the platelet count was ≥ 20 × 109/L. Ensure that no platelet transfusions were administered for seven days immediately preceding this date. Include day seven, as shown in Example 1 above, when determining the recovery date.
If three laboratory values were not obtained on consecutive days, but a sequential rise of ≥ 20 × 109/L is demonstrated, follow the examples below when determining an estimated date.
A. The recipient is being seen in the outpatient clinic and receives a platelet transfusion on January 1. The platelet count is 22 × 109/L on January 2, 24 × 109/L on January 3, and 28 × 109/L on January 4. The recipient does not come into the clinic for evaluation until one month later. The recipient has not received any more platelet transfusions and the platelet count is well above 20 × 109/L. Report January 8 (day seven post-platelet transfusion) for the date of platelet recovery.
B. The recipient is being seen in the outpatient clinic and receives a platelet transfusion on January 1. The platelet count is ≥ 20 × 109/L on January 2, January 3, and January 4. The recipient is then discharged back to their primary care physician. The transplant center receives a follow-up note from the primary care physician that states “recipient recovered their platelets in January of 2011.” Report an estimated date of recovery using the guidelines available in General Instructions, General Guidelines for Completing Forms.
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