AML 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 AML.

Disease Classification

Specify the AML classification at diagnosis:
Report recipient disease classification for AML from the available options in the dropdown list.
• APL with t(15;17)(q24.1;q21.2)/PML::RARA
• APL with t(15;17)(q24.1;q21.2)/PML::RARA
• APL with t(1;17)(q42.3;q21.2)/IRF2BP2::RARA
• APL with t(5;17)(q35.1;q21.2)/NPM1::RARA
• APL with t(11;17)(q23.2;q21.2)/ZBTB16::RARA
• APL with cryptic inv(17) or del(17)(q21.2q21.2)/STAT5B::RARA
• APL with STAT3::RARA
• APL other recurring translocations involving RARA
• AML with t(8;21)(q22;q22.1)/RUNX1::RUNX1T1
• AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22)/CBFB::MYH11
• AML with t(9;11)(p21.3;q23.3)/MLLT3::KMT2A
• AML with t(4;11)(q21.3;q23.3)/AFF1::KMT2A
• AML with t(6;11)(q27;q23.3)/AFDN::KMT2A
• AML with t(10;11)(p12.3;q23.3)/MLLT10::KMT2A
• AML with t(10;11)(q21.3;q23.3)/TET1::KMT2A
• AML with t(11;19)(q23.3;p13.1)/KMT2A::ELL
• AML with t(11;19)(q23.3;p13.3)/KMT2A::MLLT1
• AML with t(6;9)(p22.3;q34.1)/DEK::NUP214
• AML with inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/GATA2, MECOM
• AML with t(2;3)(p11.23;q26.2)/MECOM::?
• AML with t(3;8)(q26.2;q24.2)/MYC, MECOM
• AML with t(3;12)(q26.2;p13.2)/ETV6::MECOM
• AML with t(3;21)(q26.2;q22.1)/MECOM::RUNX1
• AML with other rare recurring translocations
• AML with mutated NPM1
• AML with in-frame bZIP mutated CEBPA
• AML with t(9;22)(q34.1;q11.2)/BCR::ABL1*
• AML with mutated TP53
• AML with myelodysplasia-related gene mutations (defined by mutations in ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2)
• AML with myelodysplasia-related cytogenetic abnormalities
• AML not otherwise specified

Specify AML with other rare recurring translocations:
Specify the AML classification from the available options in the EDC.
• TBL1XR1 (3q26.3)
• FIP1L1 (4q12)
• BCOR (Xp11.4)
• AML with t(1;3)(p36.3;q21.3)/PRDM16::RPN1
• AML (megakaryoblastic) with t(1;22)(p13.3;q13.1)/RBM15::MRTFA
• AML with t(3;5)(q25.3;q35.1)/NPM1::MLF1
• AML with t(5;11)(q35.2;p15.4)/NUP98::NSD1
• AML with t(7;12)(q36.3;p13.2)/ETV6::MNX1
• AML with t(8;16)(p11.2;p13.3)/KAT6A::CREBBP
• AML with t(10;11)(p12.3;q14.2)/PICALM::MLLT10
• AML with t(11;12)(p15.4;p13.3)/NUP98::KMD5A
• AML with NUP98 and other partners
• AML with t(16;21)(p11.2;q22.2)/FUS::ERG
• AML with t(16;21)(q24.3;q22.1)/RUNX1::CBFA2T3
• AML with inv(16)(p13.3q24.3)/CBFA2T3::GLIS2

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

Did AML progress from MDS:
Report whether AML progressed from MDS as “Yes” or “No”.

Did AML progress from MDS/MPN:
Report whether AML progressed from MDS/MPN as “Yes” or “No”.

Specify MDS/MPN:
This field will only appear in the EDC if “Did AML progress from MDS/MPN” is answered Yes. Specify the MDS/MPN classification from the available options in the EDC.
• CMML
• MDS/MPN with neutrophilia
• MDS/MPN with SF3B1 mutation and thrombocytosis
• MDS/MPN, not otherwise specified

*If both “Did AML progress from MDS” and “Did AML progress from MDS/MPN” are answered Yes, a query will appear in EDC. Either one or the other of these questions should be answered Yes, but not both.

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 predisposition due to CEBPA P/LP variants
• Germline predisposition due to DDX41 P/LP variants
• Germline TP53 P/LP variant (Li-Fraumeni syndrome)
• Germline predisposition due to RUNX1 P/LP variants
• Germline predisposition due to ANKRD26 P/LP variants
• Germline predisposition due to ETV6 P/LP variants
• Germline predisposition due to GATA2 P/LP variants
• Severe congenital neutropenia
• Shwachman-Diamond syndrome
• Fanconi anemia
• Telomere biology disorders/short telomere syndromes
• CBL syndrome
• Noonan syndrome
• Nerofibromatosis type 1
• Down syndrome
• Germline predisposition due to SAMD9 P/LP variants
• Germline predisposition due to SAMD9L P/LP variants
• Bloom syndrome
• Germline predisposition due to CHEK2 P/LP variants
• Germline predisposition due to MPL P/LP variants
• Germline predisposition due to RECQL4 P/LP variants
• Hereditary breast and ovarian cancer (BRCA1)
• Hereditary breast and ovarian cancer (BRCA2)
• Lynch syndrome
• Nijmegen breakage syndrome
• Wiskott-Aldrich syndrome
• Germline predisposition due to CSF3R P/LP variants
• Germline predisposition due to ERCC6L2 P/LP variants
• Germline predisposition due to JAK2 P/LP variants
• Germline predisposition due to MBD4 P/LP variants
• Germline predisposition due to MECOM/EV11 P/LP variants
• Germline predisposition due to NPM1 P/LP variants
• Germline pre-disposition due to RBBP6 P/LP variants
• Germline predisposition due to SRP72 P/LP variants
• Germline predisposition due to TET2 P/LP variants

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
  

Is an ELN risk category at diagnosis available for this subject:
Report the subject’s ELN risk category at diagnosis from the options available in the EDC.

ELN risk category at diagnosis:
This field will only appear in the EDC if “Is an ELN risk category at diagnosis available for this subject” is answered Yes ELN 2022 or Yes ELN 2017. Report the ELN risk category at diagnosis from the options available in the EDC.

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