MPN Pre-HCT Disease Evaluation

*The timeline requirements for this form are as follows:
Assessment Time Frame: Within 45 days prior to the anticipated start of the conditioning regimen.
Submission Time Frame: Within 5 business days of collection.

*This form will only appear in the EDC if the “Specify the disease indication at diagnosis” field on Recipient Disease form is answered MPN.

Specify the MPN classification at diagnosis:
Report recipient disease classification for MPN from the available options in the dropdown list.
• Chronic myeloid leukemia (CML)
• Polycythemia Vera (PCV)
• Essential thrombocythemia (ET)
• Primary myelofibrosis (PMF)
• Chronic neutrophilic leukemia
• Chronic eosinophilic leukemia
• Myeloproliferative neoplasm, not otherwise specified

Specify the maximum DIPSS score the subject ever achieved:
Subjects will be scored according to the Dynamic International Prognostic Scoring System (DIPSS), a risk stratification tool, which results in a numeric score associated with prognosis. Points are assigned to various risk factors. Report the maximum DIPSS score ever achieved in a format of “X.X”.

DIPSS Risk Group	Score
Low	0
Intermediate-1	1-2
Intermediate-2	3-4
High	≥ 5

Specify when the maximum DIPSS score was documented:
Report the when the maximum DIPSS score was documented as “Diagnosis” or “Between diagnosis and conditioning”.

Specify the maximum DIPSS plus score the subject ever achieved:
Report the maximum DIPSS plus score ever achieved in a format of “X.X”.

*An unfavorable karyotype would be defined as a complex karyotype or abnormalities including +8, 7/7q, i(17q), 5/5q, 12p-, inv(3) or 11q23 rearrangement.

DIPSS Risk Group	Score
Low	0
Intermediate-1	1-2
Intermediate-2	3-4
High	≥ 5

Specify when the maximum DIPSS plus score was documented:
Report the when the maximum DIPSS plus score was documented as “Diagnosis” or “Between diagnosis and conditioning”.

If disease classification is not CML, specify the pre-transplant disease status:
If “Specify the MPN classification at diagnosis” is NOT answered CML, report the subject’s pre-transplant disease status from the options available in the EDC.
• CR1
• CR2
• CR3 or subsequent remission
• Clinical Improvement (CI)
• Stable disease (SD)
• Progressive Disease
• Relapse

This field will only appear if Specify the MPN classification at diagnosis is not answered Chronic myeloid leukemia (CML).

If disease classification is CML, specify the pre-transplant disease status:
If “Specify the MPN classification at diagnosis” is answered CML, report the subject’s pre-transplant disease status from the options available in the EDC.
• Complete hematologic response preceded only by chronic phase
• Complete hematologic response preceded by accelerated phase and/or blast phase
• Chronic Phase

This field will only appear if Specify the MPN classification at diagnosis is answered Chronic myeloid leukemia (CML).

Specify level of best response:
Report the subject’s level of best response from the options available in the EDC.
• No cytogenetic response
• Minimal cytogenetic response
• Minor cytogenetic response
• Partial cytogenetic response
• Complete cytogenetic response
• Major molecular remission
• Complete molecular remission

Specify level of best response:
Report the subject’s level of best response from the options available in the EDC.
• No cytogenetic response
• Minimal cytogenetic response
• Minor cytogenetic response
• Partial cytogenetic response
• Complete cytogenetic response
• Major molecular remission
• Complete molecular remission

CCG v1.0 | CRF v1.3

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