Q9-27: Hematologic Findings Prior to Lymphodepleting Therapy

*Lymphodepleting Therapy and Current Hematologic Findings
The following questions are enabled only if the recipient received lymphodepleting therapy as reported on the Pre-CTED (4000) form.

*Hematologic Findings and TED vs CRF
Current hematologic findings data collection has been split between TED and CRF level reporting. TED level reporting will capture only LDH values. All other lab values will be captured on the Pre-Cellular Therapy Baseline Data (4001) form if the infusion is selected for CRF level reporting.

Questions 9-18: Complete blood count results available (check all that apply)

These questions are intended to determine the clinical status of the recipient prior to the start of lymphodepleting therapy for cellular therapy. Testing may be performed multiple times within the pre- infusion work-up time period; report the most recent CBC prior to the start of lymphodepleting therapy. If lymphodepleting therapy was not given, report the most recent CBC prior to the infusion.

Report the date of the most recent complete blood count in the reporting period and select all hematologic results available. Report the associated laboratory value and unit of measurement (if applicable).

For hematocrit, check the box if red blood cells were transfused within 30 days prior to the testing.

For platelets, check the box if platelets were transfused within seven days prior to the testing.

Question 19: Did the recipient receive any growth factors < 7 days before the start of systemic therapy? (or long acting growth factor within 14 days prior)

Indicate if the recipient received any growth factor (e.g., GCS-F) within seven days prior to the start of systemic therapy (i.e. lymphodepleting therapy). If no systemic therapy was given, indicate if the recipient received any growth factor (e.g., GCS-F) within seven days prior to the infusion. In the event of a long acting growth factor (e.g., pegfilgrastim (Neulasta®), report Yes if the recipient received it within 14 days prior.

Questions 20-21: Total serum ferritin

Ferritin is a protein that stores, transports, and release iron. Iron is toxic to cells, so it is stored within the ferritin protein for use. Ferritin that is too low might be indicative of iron deficiency related anemia. Ferritin that is too high might be indicative of iron overload. It is tracked for some diseases, such as hemophagocytic lymphohistiocytosis (HLH). Report the most recent ferritin completed prior to the start of lymphodepleting therapy and specify the sample collection date.

Testing may be performed multiple times within the pre- infusion work-up time period; report the most recent total serum ferritin value obtained within 30 days of the start of lymphodepleting therapy. Laboratory values obtained on the first day of the lymphodepleting therapy may be reported as long as the blood was drawn before any lymphodepleting therapy was administered.

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

If a ferritin value was not obtained within 30 days of the start of LD therapy, the question should be left blank and override the error with the code “Not tested”. .

Question 22-25: C-reactive protein

Indicate whether the C-reactive protein result was Known or Unknown prior to the start of lymphodepleting therapy. If Known, report the date of the test, the result, unit of measurement, and specify the upper limit of normal.

Testing may be performed multiple times within the pre- infusion work-up time period; report the most recent C-reactive protein value obtained within 30 days of the start of lymphodepleting therapy. Laboratory values obtained on the first day of the lymphodepleting therapy may be reported as long as the blood was drawn before any lymphodepleting therapy was administered.

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

If a C-reactive protein value was not obtained within 30 days of the start of LD therapy, select Unknown.

Question 26-27: Serum creatinine

Creatinine is a normal metabolic waste that is primarily filtered from the blood by the kidneys and then excreted in the urine. Since it is generally produced at a constant rate, the clearance rate and the serum level are widely used as indicators of kidney function. Report the most recent creatinine completed prior to the start of lymphodepleting therapy and units of measurement, along with specifying the sample collection date.

Testing may be performed multiple times within the pre- infusion work-up time period; report the most recent serum creatinine value obtained. Laboratory values obtained on the first day of the lymphodepleting therapy may be reported as long as the blood was drawn before any lymphodepleting therapy was administered.

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

If a creatinine value was not obtained within 30 days of the start of LD therapy, the question should be left blank and override the error using the code “Not Tested.”

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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