ALL 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 ALL.

Specify the ALL classification at diagnosis:
Report recipient disease classification for ALL from the available options in the dropdown list.

• B-lymphoblastic leukemia/lymphoma with high hyperdiploidy
• B-lymphoblastic leukemia/lymphoma with hypodiploidy
• B-lymphoblastic leukemia/lymphoma with iAMP21
• B-lymphoblastic leukemia/lymphoma with BCR-ABL1 fusion
• B-lymphoblastic leukemia/lymphoma with BCR-ABL1-like features
• B-lymphoblastic leukemia/lymphoma with KMT2A rearrangement
• B-lymphoblastic leukemia/lymphoma with ETV6::RUNX1 fusion
• B-lymphoblastic leukemia/lymphoma with ETV6::RUNX1-like features
• B-lymphoblastic leukemia/lymphoma with TCF::PBX1 fusion
• B-lymphoblastic leukemia/lymphoma with IGH:IL3 fusion
• B-lymphoblastic leukemia/lymphoma with TCF3::HLF fusion
• B-lymphoblastic leukemia/lymphoma with other defined genetic abnormalities
• B-lymphoblastic leukemia/lymphoma, not otherwise specified
• Early T-precursor lymphoblastic leukemia/lymphoma with other defined genetic abnormalities
• T-lymphoblastic leukemia/lymphoma, not otherwise specified

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 from the available options in the dropdown list.

• 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)
• Down syndrome
  

Specify the pre-transplant disease status:
Report the subject’s pre-transplant disease status from the options available in the EDC.

Completion Remission (CR) is defined as:

• <5% blasts in the bone marrow
• No circulating blasts
• No evidence of extramedullary disease
  

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