The reporting of peripheral blood count recoveries on the Cellular Therapy Essential Data Follow-Up (4100) form has a different intent than the Post-HSCT Data (2100) or Post-Transplant Essential Data (2450). Systemic therapy (such as lymphodepleting therapy given prior to a CAR-T infusion) may negatively impact ANC and platelet counts. 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.
The intent of the questions on the Cellular Therapy Essential Data Follow-Up (4100) form is to determine cell count recovery post systemic therapy, not as a measure of engraftment. These questions are not applicable to all cellular therapies. Not all types of cellular therapies require a course of systemic therapy prior to the infusion.
Question 7: Was there evidence of initial 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 consecutive 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 or if the recipient did not receive lymphodepleting therapy. This option is only applicable in the Day 100 reporting period.
- Select this option for infusions where systemic therapy was not given pre-infusion
- Previously reported if this is the six-month or annual follow-up, and ANC initial recovery (including Not applicable) has already been reported on a previous form.
Question 8: Date ANC >500/mm3 (first of 3 consecutive 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.
Question 9: Following the initial recovery, was there subsequent decline in ANC to < 500/mm3 for ≥ 3 days since the date of last report?
Indicate Yes or No if there was subsequent decline in ANC < 500/mm3(or < 0.5 × 109/L) (three consecutive laboratory values obtained on different days where the ANC declined to < 500/mm3.
Question 10: Date of decline in ANC to < 500/mm3 for ≥ 3 days (first of 3 days that the ANC declined)
Enter the first date of the three consecutive laboratory values obtained on different days where the ANC declined to < 500/mm3 (or < 0.5 × 109/L). For an example of tracking ANC recovery, see the Tracking ANC Recovery in the ANC and Platelet Recovery reporting overview.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Question 11: Did recipient recover and maintain ANC ≥ 500/mm3 following the decline?
Indicate Yes or No whether there was evidence of ANC recovery following the decline (three consecutive laboratory values obtained on different days where the ANC was ≥ 500/mm3 (or ≥ 0.5 × 109/L).
Questions 12: Date of ANC recovery
Enter the first date of the three consecutive laboratory values obtained on different days where the ANC recovered to ≥ 500/mm3 (or ≥ 0.5 × 109/L) following the decline.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Question 13: Was an initial platelet count > 20 × 109/L achieved?
Specify if there was evidence of initial platelet recovery following this infusion, using the following guidelines
- Yes: Platelet count ≥ 20 × 109 / L was achieved and sustained for 3 consecutive laboratory values, obtained on different days without platelet transfusions administered in the previous 7 days
- No: Platelet count was not ≥ 20 × 109 / L or if platelet transfusions were administered in the previous 7 days.
- Not applicable: The platelets never dropped below 20 × 109/L at any time post-infusion and a platelet transfusion was never required at time post-cellular therapy infusion or if the recipient did not receive lymphodepleting therapy.
- 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 Day 100 reporting period.
- Select this option for infusions where systemic therapy was not given pre-infusion
- Previously reported: This is the six-month or annual follow-up, and initial platelet recovery has already been reported on a previous form.
Question 14: 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 the Reporting Platelet Recovery example in the ANC and Platelet Recovery reporting overview, 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.
Reporting Scenarios
- Example 1: 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.
- Example 2: 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 2023.” Report an estimated date of recovery using the guidelines available in General Instructions, General Guidelines for Completing Forms.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Question 15: Following the initial platelet recovery, was there subsequent decline in platelets to < 20 × 109/L for >3 days?
Indicate Yes or No if there was subsequent decline in platelets < 20 × 109/L (three consecutive laboratory values obtained on different days where the platelets to < 20 × 109/L).
Question 16: Date of decline in platelets to < 20 × 109/L for ≥ 3 days (first of 3 days that the platelets declined)
Enter the first date of the three consecutive laboratory values obtained on different days where the platelets declined to < 20 × 109/L.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Question 17: Did recipient recover and maintain platelets ≥ 20 × 109/L following the decline?
Indicate Yes or No if there was evidence of platelet recovery following the decline (three consecutive laboratory values obtained on different days where the platelets were > 20 × 109/L).
Question 18: Date of platelet recovery
Enter the first date of the three consecutive laboratory values obtained on different days where the platelets recovered to ≥ 20 × 109/L L following the decline.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| . | . | . | . | . |
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