MDS 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 MDS.

Disease Classification

Specify the MDS classification at diagnosis:
Report recipient disease classification for MDS from the available options in the dropdown list.
• MDS with low blasts and isolated 5q deletion (MDS-5q)
• MDS with low blasts and SF3B1 Mutation (MDS-SF3B1)
• MDS with biallelic TP53 inactivation (MDS-biTP53)
• MDS with other defined genetic alterations
• MDS with low blasts (MDS-LB)
• MDS, hypoplastic (MDS-h)
• MDS with increased blasts (MDS-IB1)
• MDS with increased blasts (MDS-IB2)
• MDS with fibrosis (MDS-f)
• MDS, not otherwise specified

Is MDS therapy related:
Report whether AML is therapy related as “Yes” or “No”.

Did subject have a predisposing condition:
Report whether the subject had a predisposing condition as “Yes” or “No”.

Specify pre-disposing condition:
This field will only appear in the EDC if “Did subject have a predisposing condition” is answered Yes. Report the subject’s predisposing condition form the available options in the dropdown list.
• Germline CEBPA P/LP variants
• Germline DDX41 P/LP variants
• Germline TP53 P/LP variant (Li-Fraumeni syndrome)
• Germline RUNX1 P/LP variant (familial platelet disorder with associated myeloid malignancy, FPD-MM)
• Germline ANKRD26 P/LP variant (thrombocytopenia 2)
• Germline ETV6 P/LP variant (thrombocytopenia 5)
• Germline GATA2 P/LP variant
• Severe congenital neutropenia
• Shwachman-Diamond syndrome
• Fanconi anemia
• Telomere biology disorders/short telomere syndromes
• RASopathies (Neurofibromatosis type 1, CBL syndrome, Noonan syndrome or Noonan syndrome-like disorders)
• Down syndrome
• Germline SAMD9P/LP variant (MIRAGE syndrome)
• Germline SAMD9L P/LP variant (Bloom syndrome)

Specify the pre-transplant disease status:
Report the subject’s pre-transplant disease status from the options available in the EDC.
• CR1
• CR2
• CR3 or subsequent remission
• Hematologic Improvement (HI)
• No response (NR) / Stable disease (SD)
• Progression from HI

Is an IPSS-R at diagnosis available for this subject:
Report whether an IPSS-R at diagnosis is available for this subject as “Yes” or “No”.

IPSS-R:
This field will only appear in the EDC if “Is an IPSS-R at diagnosis available for this subject:” is answered Yes. Report the IPPS-R from the options available in the EDC.
• Very low
• Low
• Intermediate
• High
• Very high

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