ID

1909

Description

ENR Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF19AF22-C849-2763-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF19AF22-C849-2763-E034-0003BA3F9857

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Leukemia, Myelocytic, Acute null Treatment - ENR - 2395563v3.0

English

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1 forms  
Aml T Cell Depletion - Segment A
Description

Aml T Cell Depletion - Segment A

Record date patient informed consent form was signed
Description

DateInformedConsentFormsignedbypatient

Data type

text

Record donor's birthdate
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Record the proposed start date of conditioning
Description

TreatmentStartDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Patient Inclusion Criteria
Description

Patient Inclusion Criteria

Were Auer rods present
Description

LaboratoryProcedureAuerRodsOutcomeStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25287
UMLS 2011AA Property
C0333828
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Date of most recent bone marrow aspirate
Description

BoneMarrowAspirateDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C13347
UMLS 2011AA Property
C0370199
If yes, record the percentage of blasts in most recent biopsy
Description

LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12918
UMLS 2011AA Property
C0368761
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
If yes, record the percentage of blasts in most recent biopsy
Description

LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12918
UMLS 2011AA Property
C0368761
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
Date of bone marrow biopsy
Description

BoneMarrowBiopsyDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Record the patients Karnofsky performance status
Description

KarnofskyPerformanceStatusScore

Data type

text

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Does the patient meet the World Health Organizations (WHO) criteria for do novo AML
Description

DoesthepatientmeettheWorldHealthOrganizations(WHO)criteriafordonovoAML

Data type

text

Record the patients most recent complete remission stage
Description

Recordthepatientsmostrecentcompleteremissionstage

Data type

text

Record the date the most recent complete remission
Description

Recordthedatethemostrecentcompleteremission

Data type

text

Was an adequate bone marrow aspirate performed within 4 weeks prior to the proposed conditioning date
Description

Wasanadequatebonemarrowaspirateperformedwithin4weekspriortotheproposedconditioningdate

Data type

text

If an adequate bone marrow aspirate was not perforned, was a bone marrow biopsy performed within 4 weeks prior to the proposed conditioning date
Description

Ifanadequatebonemarrowaspiratewasnotperforned,wasabonemarrowbiopsyperformedwithin4weekspriortotheproposedconditioningdate

Data type

text

Is there any evidence of a persistently abnormal leaukemia population by flow cytometry
Description

Isthereanyevidenceofapersistentlyabnormalleaukemiapopulationbyflowcytometry

Data type

text

Is there any evidence of extramedullary leukemia
Description

Isthereanyevidenceofextramedullaryleukemia

Data type

text

Does the patient have a history of CNS involvement
Description

DoesthepatienthaveahistoryofCNSinvolvement

Data type

text

If yes, is there any evidence of leukemia blasts in the CSF
Description

Ifyes,isthereanyevidenceofleukemiablastsintheCSF

Data type

text

Indicate the number of cycles of infuction chemotherapy (or in0induction for patients in 2nd CR) the patient received to achieve first or second complete remission
Description

Indicatethenumberofcyclesofinfuctionchemotherapy(orin0inductionforpatientsin2ndCR)thepatientreceivedtoachievefirstorsecondcompleteremission

Data type

text

Indicate the number of consolidation therapies the patient received prior to transplant (any consolidation regimen that does not require transplantation for hematopoetic recovery can be used)
Description

Indicatethenumberofconsolidationtherapiesthepatientreceivedpriortotransplant(anyconsolidationregimenthatdoesnotrequiretransplantationforhematopoeticrecoverycanbeused)

Data type

text

Left Ventricular Ejection Fraction
Description

Left Ventricular Ejection Fraction

Most recent value
Description

HeartLVEFTestPercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
Date of assessment
Description

HeartLVEFTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
ULN for your institution
Description

ULNforyourinstitution

Data type

text

Bilirubin
Description

Bilirubin

Most recent value
Description

HepaticBilirubinLabValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
ULN for your institution
Description

HepaticBilirubinLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Date of assessment
Description

LaboratoryProcedureBilirubinOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Alt
Description

Alt

Most recent value
Description

ALTValue

Data type

double

Date of assessment
Description

SpecimenLaboratoryProcedureCollectionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
ULN for your institution
Description

ULNforyourinstitution

Data type

text

Ast
Description

Ast

Most recent value
Description

HepaticSGOT(AST)LabUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ULN for your institution
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Date of assessment
Description

SpecimenLaboratoryProcedureCollectionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
Serum Creatinine
Description

Serum Creatinine

Most recent value
Description

RenalCreatinineLabSpecifiedValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
ULN for your institution
Description

LaboratoryProcedureCreatinineResultUpperLimitofNormalValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
mg/dL
Date of assessment
Description

LaboratoryProcedureEvaluationPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Dlco (corrected For Hemoglobin)
Description

Dlco (corrected For Hemoglobin)

Most recent value
Description

LungCarbonMonoxideDiffusingCapabilityTestAssessmentPredictiveValuePercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property
C38083
UMLS 2011AA Property
C1516251
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C16238
UMLS 2011AA ValueDomain
C1514307
%
Date of assessment
Description

LaboratoryProcedureEvaluationPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
ULN for your institution
Description

ULNforyourinstitution

Data type

text

Patient Exclusion Criteria
Description

Patient Exclusion Criteria

Date approved by medical monitor
Description

CriteriaApprovalDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Is the patient HIV seropositive
Description

AntibodyHIVTestStatus

Data type

text

Alias
NCI Thesaurus Property
C14219
UMLS 2011AA Property
C0019682
NCI Thesaurus ObjectClass
C16295
UMLS 2011AA ObjectClass
C0003241
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Does the patient have uncontrolled diabetes mellitus
Description

Doesthepatienthaveuncontrolleddiabetes?

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Is the patient diagnosed with an uncontrolled viral, bacterial, or fungal infection
Description

PatientInfectionInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
Description

PatientPregnancyInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
Is the patient doagnosed with M3-AML (acute promyelocytic leukemia and in first complete remission)
Description

IsthepatientdoagnosedwithM3-AML(acutepromyelocyticleukemiaandinfirstcompleteremission)

Data type

text

Is the patient diagnosed with acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease
Description

Isthepatientdiagnosedwithacuteleukemiafollowingblasttransformationofpriorchronicmyelogenousleukemia(CML)orothermyeloproliferativedisease

Data type

text

Is the patient diagnosed with M4Eo-AML with inv 16 and in first complete remission
Description

IsthepatientdiagnosedwithM4Eo-AMLwithinv16andinfirstcompleteremission

Data type

text

Is the patient diagnosed with AML with t(8;21) and in first complete remission
Description

IsthepatientdiagnosedwithAMLwitht(8;21)andinfirstcompleteremission

Data type

text

Is the patient participating in other clinical trails that involve investigational drugs or devices
Description

Isthepatientparticipatinginotherclinicaltrailsthatinvolveinvestigationaldrugsordevices

Data type

text

Does the patient have a history of cytopenia consistent with diagnoses of myelodysplastic syndrome (MDS) for more then 3 months prior to the diagnosis of Aml or does the patient have reatments-related AML
Description

Doesthepatienthaveahistoryofcytopeniaconsistentwithdiagnosesofmyelodysplasticsyndrome(MDS)formorethen3monthspriortothediagnosisofAmlordoesthepatienthavereatments-relatedAML

Data type

text

Does the patients have evidence of active Hepatitis B or C infection or evidence of cirrhosis
Description

DoesthepatientshaveevidenceofactiveHepatitisBorCinfectionorevidenceofcirrhosis

Data type

text

No
Description

No

Data type

text

Does the patient have a documented allergy to iron dextran or murine proteins and rabbit antithymocyte globulin
Description

Doesthepatienthaveadocumentedallergytoirondextranormurineproteinsandrabbitantithymocyteglobulin

Data type

text

Has the patient had a prior allogeneic or autologous transplant
Description

Hasthepatienthadapriorallogeneicorautologoustransplant

Data type

text

Donor Inclusion Criteria
Description

Donor Inclusion Criteria

Record date donor centent was signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Record donor's birthdate
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Record donor's weight
Description

PatientWeightMeasurement

Data type

double

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
Is the donor HIV seronegative within 30 days of apheresis collection
Description

HumanImmunodeficiencyVirusDiagnosisInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C14219
UMLS 2011AA ObjectClass
C0019682
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Is the donor seronegative for hepatitis B surface antigen within 30 days of apheresis collection
Description

TransplantDonorHepatitisBSurfaceAntigenInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25168
UMLS 2011AA ObjectClass
C0040288
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Metathesaurus Property
C0019168
Is the donor seronegative for hepatitis C within 30 days of apheresis collection
Description

TransplantDonorHepatitisCVirusAntibodyInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25168
UMLS 2011AA ObjectClass
C0040288
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Thesaurus Property
C14312
UMLS 2011AA Property
C0220847
NCI Thesaurus Property
C16295
UMLS 2011AA Property
C0003241
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
Description

PatientPregnancyInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
Is the donor seronegative for syphilis within 30 days fo apheresis collection
Description

Isthedonorseronegativeforsyphiliswithin30daysfoapheresiscollection

Data type

text

Is the donor agreeable to second donation of PBSC in the event of graft failure of EBV-related lymphopropliferative diesase, if necessary
Description

IsthedonoragreeabletoseconddonationofPBSCintheeventofgraftfailureofEBV-relatedlymphopropliferativediesase,ifnecessary

Data type

text

Is the donor agreeable to undergo general anesthesia and bone marrow donation, if necessary
Description

Isthedonoragreeabletoundergogeneralanesthesiaandbonemarrowdonation,ifnecessary

Data type

text

Does the donor have adequate veins for leukapheresis or agress to placement fo a central catheter
Description

Doesthedonorhaveadequateveinsforleukapheresisoragresstoplacementfoacentralcatheter

Data type

text

Does the donor have evidence of active infection (including urinary tract infection or respiratory tract infection) or viral hepatitis exposure (on screeninig), unless only HBs, AB+ and HBV DNA negative
Description

Doesthedonorhaveevidenceofactiveinfection(includingurinarytractinfectionorrespiratorytractinfection)orviralhepatitisexposure(onscreeninig),unlessonlyHBs,AB+andHBVDNAnegative

Data type

text

Does the donoe have any factors which place him-her at increase rick for complications from leukopharesis of G-CSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy)
Description

Doesthedonoehaveanyfactorswhichplacehim-heratincreaserickforcomplicationsfromleukopharesisofG-CSFtherapy(e.g.,autoimmunedisease,sicklecelltrait,symptomaticcoronaryarterydiseaserequiringtherapy)

Data type

text

Hla Typing
Description

Hla Typing

Type of HLA Match required by this protocol
Description

HLAType

Data type

text

Recipient Hla Typing
Description

Recipient Hla Typing

Hla-a
Description

Hla-a

Typing method
Description

TransplantMatchingMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Metathesaurus Property
C0150103
Antigens/alleles provided
Description

Antigens/allelesprovided

Data type

text

1st
Description

1st

Data type

text

2nd
Description

2nd

Data type

text

Hla-b
Description

Hla-b

Typing method
Description

TransplantMatchingMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Metathesaurus Property
C0150103
Antigens/alleles provided
Description

Antigens/allelesprovided

Data type

text

1st
Description

1st

Data type

text

2nd
Description

2nd

Data type

text

Hla-c
Description

Hla-c

1st
Description

1st

Data type

text

2nd
Description

2nd

Data type

text

Hla-drb1
Description

Hla-drb1

Typing method
Description

TransplantMatchingMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Metathesaurus Property
C0150103
Antigens/alleles provided
Description

Antigens/allelesprovided

Data type

text

1st
Description

1st

Data type

text

2nd
Description

2nd

Data type

text

Donor Hla Typing
Description

Donor Hla Typing

Hla-a
Description

Hla-a

Typing method
Description

TransplantMatchingMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Metathesaurus Property
C0150103
Antigens/alleles provided
Description

Antigens/allelesprovided

Data type

text

1st
Description

1st

Data type

text

2nd
Description

2nd

Data type

text

Hla-b
Description

Hla-b

Typing method
Description

TransplantMatchingMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Metathesaurus Property
C0150103
Antigens/alleles provided
Description

Antigens/allelesprovided

Data type

text

1st
Description

1st

Data type

text

2nd
Description

2nd

Data type

text

Hla-c
Description

Hla-c

1st
Description

1st

Data type

text

2nd
Description

2nd

Data type

text

Hla-drb1
Description

Hla-drb1

Typing method
Description

TransplantMatchingMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Metathesaurus Property
C0150103
Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Antigens/alleles provided
Description

Antigens/allelesprovided

Data type

text

1st
Description

1st

Data type

text

2nd
Description

2nd

Data type

text

HLA Match score required by this protocol
Description

HLAMatchscorerequiredbythisprotocol

Data type

text

Locus-A calculated HLA Match score
Description

Locus-AcalculatedHLAMatchscore

Data type

text

Locus-B calculated HLA Match score
Description

Locus-BcalculatedHLAMatchscore

Data type

text

Locus-DRB1 calculated HLA Match score
Description

Locus-DRB1calculatedHLAMatchscore

Data type

text

Total calculated HLA Match score
Description

TotalcalculatedHLAMatchscore

Data type

text

Do you agree with the calculated HLA Match score
Description

DoyouagreewiththecalculatedHLAMatchscore

Data type

text

Indicate your institution's HLA Match score for this participant
Description

Indicateyourinstitution'sHLAMatchscoreforthisparticipant

Data type

text

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1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Aml T Cell Depletion - Segment A
DateInformedConsentFormsignedbypatient
Item
Record date patient informed consent form was signed
text
PatientBirthDate
Item
Record donor's birthdate
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
TreatmentStartDate
Item
Record the proposed start date of conditioning
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Patient Inclusion Criteria
Item
Were Auer rods present
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25287 (NCI Thesaurus Property)
C0333828 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.4
Code List
Were Auer rods present
CL Item
Auer Rods Present In Bone Marrow (Yes)
CL Item
Auer Rods Absent From Bone Marrow (No)
BoneMarrowAspirateDate
Item
Date of most recent bone marrow aspirate
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C13347 (NCI Thesaurus Property)
C0370199 (UMLS 2011AA Property)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
If yes, record the percentage of blasts in most recent biopsy
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
If yes, record the percentage of blasts in most recent biopsy
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
BoneMarrowBiopsyDate
Item
Date of bone marrow biopsy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
Item
Record the patients Karnofsky performance status
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
CL.12
Code List
Record the patients Karnofsky performance status
CL Item
Normal, No Complaints, No Evidence Of Disease (100 (Normal; no complaints/fully active_)
CL Item
Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90 (Normal activity/minor restrictions in strenuous play))
CL Item
Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80 (Normal activity with effort/restricted to strenuous play))
CL Item
Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70 (Unable to carry on normal activity/less time spent at play))
CL Item
Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60 (Requires occasional assistance/minimal active play))
CL Item
Requires Considerable Assistance And Frequent Medical Care (50 (Requires considerable assistance/no active play))
CL Item
Disabled, Requires Special Care And Assistance (40 (Disabled/needs assistance for quiet play))
CL Item
Severely Disabled, Hospitalization Indicated. Death Not Imminent (30 (severely disabled/needs assistance for quiet play))
CL Item
Very Sick, Hospitalization Indicated. Death Not Imminent (20 (Very sick/limited to very passive activity))
CL Item
Moribund, Fatal Processes Progressing Rapidly (10 (Moribund; completely disabled))
Item
Does the patient meet the World Health Organizations (WHO) criteria for do novo AML
text
CL.1
Code List
Does the patient meet the World Health Organizations (WHO) criteria for do novo AML
CL Item
Yes (Yes)
CL Item
No (No)
Item
Record the patients most recent complete remission stage
text
CL.2
Code List
Record the patients most recent complete remission stage
CL Item
First morphologic CR (First morphologic CR)
CL Item
Second morphologic CR (Second morphologic CR)
Recordthedatethemostrecentcompleteremission
Item
Record the date the most recent complete remission
text
Item
Was an adequate bone marrow aspirate performed within 4 weeks prior to the proposed conditioning date
text
CL.3
Code List
Was an adequate bone marrow aspirate performed within 4 weeks prior to the proposed conditioning date
CL Item
Yes (Yes)
CL Item
No (No)
Item
If an adequate bone marrow aspirate was not perforned, was a bone marrow biopsy performed within 4 weeks prior to the proposed conditioning date
text
CL.5
Code List
If an adequate bone marrow aspirate was not perforned, was a bone marrow biopsy performed within 4 weeks prior to the proposed conditioning date
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is there any evidence of a persistently abnormal leaukemia population by flow cytometry
text
CL.6
Code List
Is there any evidence of a persistently abnormal leaukemia population by flow cytometry
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is there any evidence of extramedullary leukemia
text
CL.7
Code List
Is there any evidence of extramedullary leukemia
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have a history of CNS involvement
text
CL.8
Code List
Does the patient have a history of CNS involvement
CL Item
Yes (Yes)
CL Item
No (No)
Item
If yes, is there any evidence of leukemia blasts in the CSF
text
CL.9
Code List
If yes, is there any evidence of leukemia blasts in the CSF
CL Item
Yes (Yes)
CL Item
No (No)
Item
Indicate the number of cycles of infuction chemotherapy (or in0induction for patients in 2nd CR) the patient received to achieve first or second complete remission
text
CL.10
Code List
Indicate the number of cycles of infuction chemotherapy (or in0induction for patients in 2nd CR) the patient received to achieve first or second complete remission
CL Item
One prior cycle (One prior cycle)
CL Item
Two prior cycles (Two prior cycles)
Item
Indicate the number of consolidation therapies the patient received prior to transplant (any consolidation regimen that does not require transplantation for hematopoetic recovery can be used)
text
CL.11
Code List
Indicate the number of consolidation therapies the patient received prior to transplant (any consolidation regimen that does not require transplantation for hematopoetic recovery can be used)
CL Item
One cycle (One cycle)
CL Item
More than one cycle (More than one cycle)
Item Group
Left Ventricular Ejection Fraction
HeartLVEFTestPercentageValue
Item
Most recent value
double
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HeartLVEFTestDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
ULNforyourinstitution
Item
ULN for your institution
text
Item Group
Bilirubin
HepaticBilirubinLabValue
Item
Most recent value
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticBilirubinLabUpperLimitNormalValue
Item
ULN for your institution
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBilirubinOutcomeDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item Group
Alt
ALTValue
Item
Most recent value
double
SpecimenLaboratoryProcedureCollectionDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
ULNforyourinstitution
Item
ULN for your institution
text
Item Group
Ast
HepaticSGOT(AST)LabUnspecifiedValue
Item
Most recent value
double
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
ULN for your institution
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
SpecimenLaboratoryProcedureCollectionDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
Item Group
Serum Creatinine
RenalCreatinineLabSpecifiedValue
Item
Most recent value
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitofNormalValue
Item
ULN for your institution
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item Group
Dlco (corrected For Hemoglobin)
LungCarbonMonoxideDiffusingCapabilityTestAssessmentPredictiveValuePercentageValue
Item
Most recent value
double
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38083 (NCI Thesaurus Property)
C1516251 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16238 (NCI Thesaurus ValueDomain)
C1514307 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
ULNforyourinstitution
Item
ULN for your institution
text
Item Group
Patient Exclusion Criteria
CriteriaApprovalDate
Item
Date approved by medical monitor
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Is the patient HIV seropositive
text
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C16295 (NCI Thesaurus ObjectClass)
C0003241 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.20
Code List
Is the patient HIV seropositive
CL Item
Positive (Yes)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Negative (No)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
Item
Does the patient have uncontrolled diabetes mellitus
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.21
Code List
Does the patient have uncontrolled diabetes mellitus
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient diagnosed with an uncontrolled viral, bacterial, or fungal infection
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
CL.22
Code List
Is the patient diagnosed with an uncontrolled viral, bacterial, or fungal infection
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL.35
Code List
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No, And Not Nursing (No)
CL Item
Not applicable (Not applicable)
Item
Is the patient doagnosed with M3-AML (acute promyelocytic leukemia and in first complete remission)
text
CL.13
Code List
Is the patient doagnosed with M3-AML (acute promyelocytic leukemia and in first complete remission)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient diagnosed with acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease
text
CL.14
Code List
Is the patient diagnosed with acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient diagnosed with M4Eo-AML with inv 16 and in first complete remission
text
CL.15
Code List
Is the patient diagnosed with M4Eo-AML with inv 16 and in first complete remission
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient diagnosed with AML with t(8;21) and in first complete remission
text
CL.16
Code List
Is the patient diagnosed with AML with t(8;21) and in first complete remission
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient participating in other clinical trails that involve investigational drugs or devices
text
CL.17
Code List
Is the patient participating in other clinical trails that involve investigational drugs or devices
CL Item
Yes (Yes)
CL Item
Yes, approved by medical monitor (Yes, approved by medical monitor)
CL Item
No (No)
Item
Does the patient have a history of cytopenia consistent with diagnoses of myelodysplastic syndrome (MDS) for more then 3 months prior to the diagnosis of Aml or does the patient have reatments-related AML
text
CL.18
Code List
Does the patient have a history of cytopenia consistent with diagnoses of myelodysplastic syndrome (MDS) for more then 3 months prior to the diagnosis of Aml or does the patient have reatments-related AML
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patients have evidence of active Hepatitis B or C infection or evidence of cirrhosis
text
CL.19
Code List
Does the patients have evidence of active Hepatitis B or C infection or evidence of cirrhosis
CL Item
Yes (Yes)
CL Item
No (No)
No
Item
No
text
Item
Does the patient have a documented allergy to iron dextran or murine proteins and rabbit antithymocyte globulin
text
CL.23
Code List
Does the patient have a documented allergy to iron dextran or murine proteins and rabbit antithymocyte globulin
CL Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient had a prior allogeneic or autologous transplant
text
CL.25
Code List
Has the patient had a prior allogeneic or autologous transplant
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Donor Inclusion Criteria
InformedConsentFormSignedDate
Item
Record date donor centent was signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientBirthDate
Item
Record donor's birthdate
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Record donor's weight
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
Item
Is the donor HIV seronegative within 30 days of apheresis collection
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.26
Code List
Is the donor HIV seronegative within 30 days of apheresis collection
CL Item
No (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (No)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the donor seronegative for hepatitis B surface antigen within 30 days of apheresis collection
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25168 (NCI Thesaurus ObjectClass)
C0040288 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0019168 (NCI Metathesaurus Property)
CL.27
Code List
Is the donor seronegative for hepatitis B surface antigen within 30 days of apheresis collection
CL Item
No (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (No)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the donor seronegative for hepatitis C within 30 days of apheresis collection
text
C25168 (NCI Thesaurus ObjectClass)
C0040288 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C14312 (NCI Thesaurus Property)
C0220847 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.28
Code List
Is the donor seronegative for hepatitis C within 30 days of apheresis collection
CL Item
No (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (No)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL.35
Code List
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No, And Not Nursing (No)
CL Item
Not applicable (Not applicable)
Item
Is the donor seronegative for syphilis within 30 days fo apheresis collection
text
CL.29
Code List
Is the donor seronegative for syphilis within 30 days fo apheresis collection
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the donor agreeable to second donation of PBSC in the event of graft failure of EBV-related lymphopropliferative diesase, if necessary
text
CL.30
Code List
Is the donor agreeable to second donation of PBSC in the event of graft failure of EBV-related lymphopropliferative diesase, if necessary
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the donor agreeable to undergo general anesthesia and bone marrow donation, if necessary
text
CL.31
Code List
Is the donor agreeable to undergo general anesthesia and bone marrow donation, if necessary
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the donor have adequate veins for leukapheresis or agress to placement fo a central catheter
text
CL.32
Code List
Does the donor have adequate veins for leukapheresis or agress to placement fo a central catheter
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the donor have evidence of active infection (including urinary tract infection or respiratory tract infection) or viral hepatitis exposure (on screeninig), unless only HBs, AB+ and HBV DNA negative
text
CL.33
Code List
Does the donor have evidence of active infection (including urinary tract infection or respiratory tract infection) or viral hepatitis exposure (on screeninig), unless only HBs, AB+ and HBV DNA negative
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the donoe have any factors which place him-her at increase rick for complications from leukopharesis of G-CSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy)
text
CL.34
Code List
Does the donoe have any factors which place him-her at increase rick for complications from leukopharesis of G-CSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy)
CL Item
Yes (Yes)
CL Item
No (No)
Item Group
Hla Typing
Item
Type of HLA Match required by this protocol
text
CL.36
Code List
Type of HLA Match required by this protocol
CL Item
High level DNA (High level DNA)
CL Item
Low level DNA (Low level DNA)
CL Item
Serologic (Serologic)
CL Item
Loci A, B: serologic, locus DRB1, low level DNA (Loci A, B: serologic, locus DRB1, low level DNA)
CL Item
Loci A, B: low level DNA, locus DRB1: high level DNA (Loci A, B: low level DNA, locus DRB1: high level DNA)
CL Item
Loci A, B: serologic; locus DRB1: high level DNA (Loci A, B: serologic; locus DRB1: high level DNA)
Item Group
Recipient Hla Typing
Item Group
Hla-a
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL.47
Code List
Typing method
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
Item
Antigens/alleles provided
text
CL.38
Code List
Antigens/alleles provided
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
Item Group
Hla-b
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL.47
Code List
Typing method
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
Item
Antigens/alleles provided
text
CL.40
Code List
Antigens/alleles provided
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
Item Group
Hla-c
1st
Item
1st
text
2nd
Item
2nd
text
Item Group
Hla-drb1
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL.47
Code List
Typing method
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
Item
Antigens/alleles provided
text
CL.42
Code List
Antigens/alleles provided
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
Item Group
Donor Hla Typing
Item Group
Hla-a
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL.47
Code List
Typing method
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
Item
Antigens/alleles provided
text
CL.44
Code List
Antigens/alleles provided
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
Item Group
Hla-b
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL.47
Code List
Typing method
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
Item
Antigens/alleles provided
text
CL.46
Code List
Antigens/alleles provided
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
Item Group
Hla-c
1st
Item
1st
text
2nd
Item
2nd
text
Item Group
Hla-drb1
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL.47
Code List
Typing method
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
Item
Antigens/alleles provided
text
CL.48
Code List
Antigens/alleles provided
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
HLAMatchscorerequiredbythisprotocol
Item
HLA Match score required by this protocol
text
Locus-AcalculatedHLAMatchscore
Item
Locus-A calculated HLA Match score
text
Locus-BcalculatedHLAMatchscore
Item
Locus-B calculated HLA Match score
text
Locus-DRB1calculatedHLAMatchscore
Item
Locus-DRB1 calculated HLA Match score
text
TotalcalculatedHLAMatchscore
Item
Total calculated HLA Match score
text
Item
Do you agree with the calculated HLA Match score
text
CL.49
Code List
Do you agree with the calculated HLA Match score
CL Item
Yes (Yes)
CL Item
No (No)
Item
Indicate your institution's HLA Match score for this participant
text
CL.50
Code List
Indicate your institution's HLA Match score for this participant
CL Item
0/6 (0/6)
CL Item
1/6 (1/6)
CL Item
2/6 (2/6)
CL Item
3/6 (3/6)
CL Item
4/6 (4/6)
CL Item
5/6 (5/6)
CL Item
6/6 (6/6)
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