Q69-96: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 69-96 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if not preparative regimen was given. Do not report testing performed during a line of therapy reported in questions 33-68. If testing was not performed near the start of the start of the preparative regimen / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable), the center should report “Unknown” for that value.

Questions 69-71: WBC

Indicate whether the white blood count (WBC) in the peripheral blood is “Known” or “Unknown” at the last evaluation prior to the start of the preparative regimen / infusion. If “Known,” report the laboratory value, unit of measure, and date sample collected. If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms. If the WBC at the last evaluation prior to the start of the preparative regimen / infusion is not known, report “Unknown” and go to question 72.

Questions 72-74: Blasts in blood

*If a differential was performed and there were no blasts present in the peripheral blood, the laboratory report may not display a column for blasts. In this case, it can be assumed that no blasts were present and “0” can be reported on the form.

Indicate whether the percent blasts in the peripheral blood is “Known” or “Unknown” at the last evaluation prior to the start of the preparative regimen / infusion. This may be determined by an automated differential, a manual count, or flow cytometry. Testing by any of these methods may be reported in questions 72-74. If “Known,” report the laboratory value, unit of measure, and date sample collected. If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms. If the percent blasts in blood at the last evaluation prior to the start of the preparative regimen / infusion is not known, report “Unknown” and go to question 75.

Questions 75-77: Blasts in bone marrow

Indicate whether the percent blasts in the bone marrow is “Known” or “Unknown” at the last evaluation prior to the start of the preparative regimen / infusion. The percent blast may be assessed by manual differential or flow cytometry. If available, report the manual differential performed on the bone marrow aspirate sample. If a manual differential was not performed on an aspirate sample, other methods / sample types may be reported (such as flow cytometry on an aspirate sample, or testing on a core biopsy) may be reported.

If “Known,” report the laboratory value, unit of measure, and date sample collected. If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms. If the percent blasts in bone marrow at the last evaluation prior to the start of the preparative regimen / infusion is not known, report “Unknown” and go to question 79.

Questions 78: Specify method of assessment

The percent blasts in the bone marrow may be assessed by a manual differential (morphology) or flow cytometry. Report the method used to determine the value reported in question 76.

Question 79: Was flow cytometry performed?

Indicate whether flow cytometry (immunophenotyping) was performed on the blood and / or bone marrow at the last evaluation prior to the start of the preparative regimen / infusion. If “Yes,” go to question 80. Report “No” and continue with question 88 if flow cytometry was not performed on the blood and / or bone marrow at the last evaluation prior to the start of the preparative regimen / infusion.

Report “Unknown” and continue with question 88 if there is no information to determine if flow cytometry was performed or not performed at the last evaluation prior to the start of the preparative regimen / infusion.

Question 80-83: Flow cytometry testing on blood

Indicate whether flow cytometry was performed on the blood at the last evaluation prior to the start of the preparative regimen / infusion. If “Yes,” report the date the sample was collected and whether disease was detected in questions 81 and 82 respectively. If disease was detected, report the percent disease detected (i.e., percent leukemic blasts) in question 83. Otherwise, go to question 84.

If flow cytometry was not performed on the blood at the last evaluation prior to the start of the preparative regimen / infusion, report “No” for question 80 and go to question 84.

Question 84-87: Flow cytometry testing on bone marrow

Indicate whether flow cytometry was performed on the bone marrow at the last evaluation prior to the start of the preparative regimen / infusion. If “Yes,” report the date the sample was collected and whether disease was detected in questions 85 and 86 respectively. If disease was detected, report the percent disease detected (i.e., percent leukemic blasts) in question 87. Otherwise, go to question 88.

If flow cytometry was not performed on the bone marrow at the last evaluation prior to the start of the preparative regimen / infusion, report “No” for question 84 and go to question 88.

Questions 88-96: Was extramedullary disease present?

Refer to the instructions for questions 23-31 for a description of extramedullary disease. If the recipient had extramedullary disease at the last evaluation prior to the start of the preparative regimen / infusion, report “Yes” for question 88 and report all extramedullary sites of involvement in questions 89-96. If the recipient did not have any extramedullary disease at this time point or it is not known whether extramedullary disease is present, report “No” or “Unknown” respectively for question 88 and submit the form.

Section Updates:

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