Q49-62: Pre-HCT Therapy

!Lines of Therapy and Subsequent Infusions
If this is a subsequent infusion and a 2015 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2015. Please report from post previous infusion to time of preparative regimen / infusion for the current infusion. If a 2015 was not previously completed, all lines of therapy from diagnosis to the current preparative regimen / infusion must be completed.

Question 49: Was therapy given?

Indicate if the recipient received treatment for JMML after the time of diagnosis and before the start of the preparative regimen. If “yes,” continue with question 50. If “no,” continue with question 63.

Questions 50-58: Specify therapy given

Indicate “yes” or “no” for each therapeutic agent or intervention listed. Do not leave any response blank. If the recipient received a chemotherapy agent that is not listed, check “yes” for “other therapy” and specify the treatment in question 58.

Question 59: Was a complete remission achieved?

Complete hematologic response (CR) is a treatment response where white blood cell count normalizes and organomegaly resolves.

Indicate if the patient achieved complete remission as a response to therapy and prior to the start of the preparative regimen.

Question 60: Date of complete remission

Enter the date complete remission was established. Report the date of the pathological evaluation (e.g., bone marrow biopsy); if no pathologic evaluation was reported, report the date of blood/serum assessment (e.g., CBC, peripheral blood smear). Enter the date the sample was collected for examination for pathological and/or laboratory evaluations. If the recipient was treated for extramedullary disease and a radiological assessment (e.g., X-ray, CT scan, MRI scan, PET scan) was performed to assess disease response, enter the date the imaging took place for radiologic assessments. If no pathological, radiographic, or laboratory assessment was performed to establish the best response to the line of therapy, report the office visit at which the physician clinically assessed the recipient’s response.

If the exact date is not known, use the process for reporting partial or unknown dates as described in General Instructions, Guidelines for Completing Forms.

Question 61: Was there a disease relapse?

Relapse is the recurrence of disease after CR. JMML relapse is demonstrated by the reappearance of disease characteristics such as leukocytosis, absolute monocytosis, and organomegaly.

Indicate if relapse occurred at any point after therapy but prior to the start of the preparative regimen. If no relapse occurred, report “no” and continue with question 63.

Question 62: Date of disease relapse

Enter the assessment date that relapse was established following the line of therapy. Report the date of the pathological evaluation (e.g., bone marrow) or blood/serum assessment (e.g., CBC, peripheral blood smear). Enter the date the sample was collected for pathological and laboratory evaluations. If extramedullary disease was detected upon radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), enter the date the imaging took place. If the physician determined cytogenetic or molecular relapse occurred, enter the date the sample was collected for cytogenetic or molecular evaluation. If the physician determined evidence of relapse following a clinical assessment during an office visit, report the date of assessment.

If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, Guidelines for Completing Forms.

Section Updates:

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