Q65-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen

These questions are intended to determine the hematological status of the recipient prior to the preparative regimen. Testing may be performed multiple times within the pre-transplant work-up period (approximately 30 days) prior to the start of the preparative regimen; report the most recent laboratory values. Laboratory values obtained on the first day of the preparative regimen may be reported as long as the sample was taken before any radiation or systemic therapy was administered.

Questions 65-66: Fetal hemoglobin (HbF)

Fetal hemoglobin is elevated in nearly 2/3 of patients with JMML and nearly all patients without monosomy 7. Greater elevation of fetal hemoglobin is associated with worse prognosis. Indicate whether fetal hemoglobin percentage immediately prior to the start of the preparative regimen is “known” or “unknown.” If “known,” report the percentage documented on the laboratory report in question 66. If “unknown,” continue with question 67.

Questions 67-68: Monocytes

Indicate whether the percentage of monocytes in the peripheral blood immediately prior to the start of the preparative regimen is “known” or “unknown.” If “known,” report the percentage documented on the laboratory report in question 68. If “unknown,” continue with question 69.

Questions 69-70: Absolute monocyte count

Indicate whether the absolute monocyte count immediately prior to the start of the preparative regimen is “known” or “unknown.” If “known,” report the laboratory count and unit of measure documented on the laboratory report in question 70. If “unknown,” continue with question 71.

Questions 71-72: Blasts in blood

Indicate whether the percentage of blasts in the peripheral blood immediately prior to the start of the preparative regimen is “known” or “unknown.” If “known,” report the percentage documented on the laboratory report in question 72. If “unknown,” continue with question 73.

*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 entered on the form.

Question 73: Were cytogenetics tested (conventional or FISH)?

Cytogenetic assessment involves testing blood or bone marrow for the presence of a known chromosomal abnormality that reflects the recipient’s disease. Testing methods include conventional chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH).

Indicate if cytogenetic studies were obtained immediately prior to the start of the preparative regimen.

If cytogenetic studies were obtained, check “yes” and continue with question 74.

If cytogenetic studies were not obtained or it is unknown if they were performed, indicate “no” or “unknown” and continue with question 82.

Question 74: Results of test

If cytogenetic studies identified abnormalities (any karyotype other than 46XX or 46XY), indicate “abnormalities identified” and continued with question 75.

If cytogenetic studies yielded no evaluable metaphases or there were no abnormalities identified, indicate such and continue with question 82.

Questions 75-81: Specify cytogenetic abnormalities identified at diagnosis

If question 74 indicates that abnormalities were identified, each of questions 75-80 must be answered as “yes” or “no.” Do not leave any response blank. Indicate “yes” for each cytogenetic abnormality identified at diagnosis or prior to first therapy in questions 75-80; indicate “no” for all options not identified on cytogenetic assessment at diagnosis or prior to first therapy. If one or more abnormalities are best classified as “other abnormality,” specify in question 81.

Question 82: Were tests for molecular markers performed (e.g., PCR)?

Molecular assessment involves testing blood or bone marrow for the presence of known molecular markers associated with the recipient’s disease. Molecular assessment is the most sensitive test for genetic abnormalities and involves amplifying regions of cellular DNA by polymerase chain reaction (PCR), typically utilizing RNA to generate complementary DNA through reverse transcription (RT-PCR).

Indicate if molecular studies were obtained immediately prior to the start of the preparative regimen.

If molecular studies were obtained, check “yes” and continue with question 83.

If molecular studies were not obtained or it is unknown if molecular studies were performed, indicate “no” or “unknown” and continue with question 88.

Questions 83-87: Specify abnormalities

If question 82 indicates that molecular markers were identified, then each of questions 83-87 must be answered as “positive,” “negative,” or “not done.” Do not leave any response blank.

See Table 2 in this manual for additional information on common molecular markers associated with JMML.

Question 88: Was the recipient’s bone marrow examined just prior to the preparative regimen?

Indicate whether the recipient had a pathologic examination of their bone marrow. If “yes,” continue with question 89. If “no” or “unknown,” continue with question 92.

Question 89: Date sample collected

Report the date the bone marrow specimen was collected for analysis.

Question 90: Blasts in bone marrow

Specify the percentage of blasts in the bone marrow as documented on the pathology report. This should be taken from the aspirate differential.

Question 91: Monocytes in bone marrow

Specify the percentage of monocytes in the bone marrow as documented on the pathology report. This should be taken from the aspirate differential.

Section Updates:

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