ID

13335

Description

Haploid Allogeneic Transplant Using the CliniMACS System; ODM derived from: https://clinicaltrials.gov/show/NCT00185679

Link

https://clinicaltrials.gov/show/NCT00185679

Keywords

Versions (1)
  1. 2/5/16 2/5/16 -
Uploaded on

February 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors NCT00185679

English

Eligibility Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors NCT00185679

1 forms  
Inclusion Criteria Recipient
Description

Inclusion Criteria Recipient

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1709854
Histopathologically-confirmed diagnosis of hematological or lymphatic malignancy, defined as one of the following:
Description

hematological or lymphatic malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0376545
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1522604
Acute myeloid leukemia (aml) as primary refractory disease, or in relapse
Description

AML as primary ref disease or in relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1514815
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0277556
acute leukemia in first remission with poor risk factors and molecular prognosis
Description

AML first remission

Data type

boolean

Alias
UMLS CUI [1,1]
C0153886
UMLS CUI [1,2]
C0205435
aml with -5,-7, t(6;9), tri8, -11
Description

chromosome abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C4015468
acute lymphocytic / lymphoblastic leukemia (all) with phil+ t(9;22),(q34;q11.2), and t(4:11)(q21;23)
Description

ALL type

Data type

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C1709527
UMLS CUI [2,1]
C0023449
UMLS CUI [2,2]
C3688703
Chronic myelogenous leukemia (cml in accelerated, second chronic phase)
Description

CML

Data type

boolean

Alias
UMLS CUI [1,1]
C0023474
UMLS CUI [1,2]
C0521110
Myelodysplastic syndrome with high intermediate to high risk categories
Description

myelodysplastic syndrome

Data type

boolean

Alias
UMLS CUI [1]
C3463824
Non-hodgkin's lymphoma (nhl)
Description

NHL

Data type

boolean

Alias
UMLS CUI [1]
C0024305
Chronic lymphocytic leukemia (cll), refractory
Description

CLL

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0205269
Creatinine clearance > 50 ml/min for those above serum creatinine of 1.5 mg/dl, serum bilirubin < 2.0 mg/dl, alt < 2x uln (unless secondary to disease)
Description

creatinine clearance bilirubin and alt measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
< 50 years old at time of registration
Description

< 50 years old at time of registration

Data type

boolean

Alias
UMLS CUI [1]
C1828181
Donor is related, Donor is genotypically-matched and haploidentical for HLA-A, B,C and DRB1, DQ loci Donor differs for 2 or 3 HLA alleles on the unshared haplotype in the GvHD direction
Description

donor criteria

Data type

boolean

Alias
UMLS CUI [1]
C3494891
UMLS CUI [2]
C1285573
UMLS CUI [3,1]
C3829897
UMLS CUI [3,2]
C0019721
UMLS CUI [4,1]
C3829897
UMLS CUI [4,2]
C0122040
UMLS CUI [5]
C0972850
No HLA-matched sibling or matched unrelated donor is identified
Description

no HLA match identified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019721
UMLS CUI [1,2]
C3242262
ECOG performance status not more than 2
Description

ECOG performance status not more than 2

Data type

boolean

Alias
UMLS CUI [1]
C1520224
LVEF
Description

LVEF

Data type

boolean

Alias
UMLS CUI [1]
C0428772
DLCO > 50%
Description

DLCO > 50%

Data type

boolean

Alias
UMLS CUI [1]
C1516251
Corrected for hemoglobin Serum creatinine < 1.5 mg/dL
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Females of childbearing potential must have a negative serum or urine beta-HCG test within 3 weeks of registration
Description

pregnancy test beta-HCG

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0106132
No prior cancer within 5 years with the exception of surgically-cured, non-melanoma skin cancer or in situ cancer of the cervix
Description

no prior cancer

Data type

text

Alias
UMLS CUI [1]
C0006826
No prior myeloablative therapy or transplant
Description

myeloablative therapy or transplant

Data type

boolean

Alias
UMLS CUI [1]
C1513784
UMLS CUI [2]
C0005961
Duly-executed informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria Recipient
Description

Exclusion Criteria Recipient

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C1709854
Suitable candidate for autologous transplantation
Description

autologous transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0040736
UMLS CUI [1,2]
C1548635
Participation in other investigational drugs or devices trials that might influence the study endpoints
Description

participation in another study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Evidence of active hepatitis
Description

active hepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0019158
UMLS CUI [1,2]
C0205177
Evidence of active cirrhosis
Description

active cirrhosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1623038
UMLS CUI [1,2]
C0205177
HIV-positive
Description

HIV positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
History of invasive aspergillosis
Description

invasive aspergillosis

Data type

boolean

Alias
UMLS CUI [1]
C0238013
Presence of any other uncontrolled, active infection, ie, bacterial, viral or fungal
Description

uncontrolled active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Uncontrolled CNS involvement
Description

uncontrolled CNS involvement

Data type

boolean

Alias
UMLS CUI [1]
C0449389
Documented allergy to murine proteins
Description

allergy to murine proteins

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
Documented allergy to iron dextran
Description

allergy to iron dextran

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0022092
Female of child-bearing potential unwilling to implement adequate birth control
Description

contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C1999124
Medical problem / neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and/or to tolerate transplantation, in the opinion of the principal investigator
Description

comorbidities affecting compliance and transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005961
Medical problem / neurologic/psychiatric dysfunction which would prolong hematologic recovery and place the recipient at unacceptable risk, in the opinion of the principal investigator would
Description

comorbidities prolonging hematologic recovery

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237820
Inclusion Criteria Donor
Description

Inclusion Criteria Donor

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0013018
Age < 60 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Weight > 25 kg
Description

weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Medical history and physical examination confirm good health status as defined by institutional standards
Description

good health status

Data type

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0205170
Within 30 days of apheresis collection, seronegative for HIV assessed as HIV Ag; HIV 1+2 Ab; or HTLV I/II Ab
Description

HIV negative

Data type

boolean

Alias
UMLS CUI [1]
C0481430
Within 30 days of apheresis collection, seronegative for hepatitis assessed as HBsAg; HBcAb (IgM and IgG); or HCV Ab
Description

seronegative for hepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0019158
UMLS CUI [1,2]
C0521144
Within 30 days of apheresis collection, seronegative for syphilis assessed as RPR
Description

seronegative for syphilis

Data type

boolean

Alias
UMLS CUI [1,1]
C0039128
UMLS CUI [1,2]
C0521144
Genotypically haploidentical as determined by HLA typing
Description

HLA haploidentical

Data type

boolean

Alias
UMLS CUI [1,1]
C0242318
UMLS CUI [1,2]
C3829897
Female donors of child-bearing potential must have a negative serum or urine beta-HCG test within 3 weeks of mobilization
Description

pregnancy test donor

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0106132
Capable of undergoing leukapheresis, Has adequate venous access
Description

capable leukapheresis

Data type

boolean

Alias
UMLS CUI [1,1]
C0023416
UMLS CUI [1,2]
C1548635
UMLS CUI [2,1]
C0750164
UMLS CUI [2,2]
C1548635
Willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
Description

consent to central catheter

Data type

boolean

Alias
UMLS CUI [1,1]
C2322576
UMLS CUI [1,2]
C1511481
Agreeable to second donation of PBPC (or a bone marrow harvest) should the recipient fail to demonstrate sustained engraftment following the transplant
Description

consent to second donation

Data type

boolean

Alias
UMLS CUI [1,1]
C0242602
UMLS CUI [1,2]
C1517331
UMLS CUI [1,3]
C1511481
Duly-executed informed consent
Description

informed consent donor

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Screened for CMV seroreactivity
Description

CMV seroreactivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0010823
UMLS CUI [1,2]
C0521143
Exclusion Criteria Donor
Description

Exclusion Criteria Donor

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0013018
Evidence of active infection (including urinary tract infection, or upper respiratory tract infection)
Description

active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0042029
UMLS CUI [3]
C0041912
Evidence of hepatitis (on screening)
Description

hepatitis donor

Data type

boolean

Alias
UMLS CUI [1]
C0019158
Medical, physical or psychological reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis
Description

contraindications to growth factor therapy and leukapheresis

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0280112
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0023416
Factors placing donor at increased risk for leukapheresis or G-CSF-related complications
Description

increased risk for leukapheresis or G-CSF-related complications

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0023416
UMLS CUI [2,1]
C0035648
UMLS CUI [2,2]
C0079459
Lactating female, Female of child-bearing potential unwilling to implement adequate birth control
Description

lactation and contraceptive use

Data type

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C1999124
HIV-positive
Description

HIV positive donor

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Acute Myelogenous Leukemia (AML) - Relapsed, Primary Refractory Disease or Poor Risk Factors NCT00185679

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria Recipient
C1512693 (UMLS CUI-1)
C1709854 (UMLS CUI-2)
hematological or lymphatic malignancy
Item
Histopathologically-confirmed diagnosis of hematological or lymphatic malignancy, defined as one of the following:
boolean
C0376545 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C1522604 (UMLS CUI [2,2])
AML as primary ref disease or in relapse
Item
Acute myeloid leukemia (aml) as primary refractory disease, or in relapse
boolean
C0023467 (UMLS CUI [1,1])
C1514815 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
AML first remission
Item
acute leukemia in first remission with poor risk factors and molecular prognosis
boolean
C0153886 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
chromosome abnormalities
Item
aml with -5,-7, t(6;9), tri8, -11
boolean
C4015468 (UMLS CUI [1])
ALL type
Item
acute lymphocytic / lymphoblastic leukemia (all) with phil+ t(9;22),(q34;q11.2), and t(4:11)(q21;23)
boolean
C0023449 (UMLS CUI [1,1])
C1709527 (UMLS CUI [1,2])
C0023449 (UMLS CUI [2,1])
C3688703 (UMLS CUI [2,2])
CML
Item
Chronic myelogenous leukemia (cml in accelerated, second chronic phase)
boolean
C0023474 (UMLS CUI [1,1])
C0521110 (UMLS CUI [1,2])
myelodysplastic syndrome
Item
Myelodysplastic syndrome with high intermediate to high risk categories
boolean
C3463824 (UMLS CUI [1])
NHL
Item
Non-hodgkin's lymphoma (nhl)
boolean
C0024305 (UMLS CUI [1])
CLL
Item
Chronic lymphocytic leukemia (cll), refractory
boolean
C0023434 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
creatinine clearance bilirubin and alt measurement
Item
Creatinine clearance > 50 ml/min for those above serum creatinine of 1.5 mg/dl, serum bilirubin < 2.0 mg/dl, alt < 2x uln (unless secondary to disease)
boolean
C0373595 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
age diagnosis CLL
Item
< 50 years old at time of registration
boolean
C1828181 (UMLS CUI [1])
donor criteria
Item
Donor is related, Donor is genotypically-matched and haploidentical for HLA-A, B,C and DRB1, DQ loci Donor differs for 2 or 3 HLA alleles on the unshared haplotype in the GvHD direction
boolean
C3494891 (UMLS CUI [1])
C1285573 (UMLS CUI [2])
C3829897 (UMLS CUI [3,1])
C0019721 (UMLS CUI [3,2])
C3829897 (UMLS CUI [4,1])
C0122040 (UMLS CUI [4,2])
C0972850 (UMLS CUI [5])
no HLA match identified
Item
No HLA-matched sibling or matched unrelated donor is identified
boolean
C0019721 (UMLS CUI [1,1])
C3242262 (UMLS CUI [1,2])
ECOG performance status
Item
ECOG performance status not more than 2
boolean
C1520224 (UMLS CUI [1])
LVEF
Item
LVEF
boolean
C0428772 (UMLS CUI [1])
DLCO
Item
DLCO > 50%
boolean
C1516251 (UMLS CUI [1])
serum creatinine
Item
Corrected for hemoglobin Serum creatinine < 1.5 mg/dL
boolean
C0201976 (UMLS CUI [1])
pregnancy test beta-HCG
Item
Females of childbearing potential must have a negative serum or urine beta-HCG test within 3 weeks of registration
boolean
C0032961 (UMLS CUI [1])
C0106132 (UMLS CUI [2])
no prior cancer
Item
No prior cancer within 5 years with the exception of surgically-cured, non-melanoma skin cancer or in situ cancer of the cervix
text
C0006826 (UMLS CUI [1])
myeloablative therapy or transplant
Item
No prior myeloablative therapy or transplant
boolean
C1513784 (UMLS CUI [1])
C0005961 (UMLS CUI [2])
informed consent
Item
Duly-executed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria Recipient
C0680251 (UMLS CUI-1)
C1709854 (UMLS CUI-2)
autologous transplantation
Item
Suitable candidate for autologous transplantation
boolean
C0040736 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
participation in another study
Item
Participation in other investigational drugs or devices trials that might influence the study endpoints
boolean
C2348568 (UMLS CUI [1])
active hepatitis
Item
Evidence of active hepatitis
boolean
C0019158 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
active cirrhosis
Item
Evidence of active cirrhosis
boolean
C1623038 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
HIV positive
Item
HIV-positive
boolean
C0019699 (UMLS CUI [1])
invasive aspergillosis
Item
History of invasive aspergillosis
boolean
C0238013 (UMLS CUI [1])
uncontrolled active infection
Item
Presence of any other uncontrolled, active infection, ie, bacterial, viral or fungal
boolean
C0009450 (UMLS CUI [1])
uncontrolled CNS involvement
Item
Uncontrolled CNS involvement
boolean
C0449389 (UMLS CUI [1])
allergy to murine proteins
Item
Documented allergy to murine proteins
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
allergy to iron dextran
Item
Documented allergy to iron dextran
boolean
C0020517 (UMLS CUI [1,1])
C0022092 (UMLS CUI [1,2])
contraceptive use
Item
Female of child-bearing potential unwilling to implement adequate birth control
boolean
C1999124 (UMLS CUI [1])
comorbidities affecting compliance and transplantation
Item
Medical problem / neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and/or to tolerate transplantation, in the opinion of the principal investigator
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005961 (UMLS CUI [2,3])
comorbidities prolonging hematologic recovery
Item
Medical problem / neurologic/psychiatric dysfunction which would prolong hematologic recovery and place the recipient at unacceptable risk, in the opinion of the principal investigator would
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237820 (UMLS CUI [1,3])
Item Group
Inclusion Criteria Donor
C1512693 (UMLS CUI-1)
C0013018 (UMLS CUI-2)
age
Item
Age < 60 years
boolean
C0001779 (UMLS CUI [1])
weight
Item
Weight > 25 kg
boolean
C0005910 (UMLS CUI [1])
good health status
Item
Medical history and physical examination confirm good health status as defined by institutional standards
boolean
C0018759 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
HIV negative
Item
Within 30 days of apheresis collection, seronegative for HIV assessed as HIV Ag; HIV 1+2 Ab; or HTLV I/II Ab
boolean
C0481430 (UMLS CUI [1])
seronegative for hepatitis
Item
Within 30 days of apheresis collection, seronegative for hepatitis assessed as HBsAg; HBcAb (IgM and IgG); or HCV Ab
boolean
C0019158 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
seronegative for syphilis
Item
Within 30 days of apheresis collection, seronegative for syphilis assessed as RPR
boolean
C0039128 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
HLA haploidentical
Item
Genotypically haploidentical as determined by HLA typing
boolean
C0242318 (UMLS CUI [1,1])
C3829897 (UMLS CUI [1,2])
pregnancy test donor
Item
Female donors of child-bearing potential must have a negative serum or urine beta-HCG test within 3 weeks of mobilization
boolean
C0032961 (UMLS CUI [1])
C0106132 (UMLS CUI [2])
capable leukapheresis
Item
Capable of undergoing leukapheresis, Has adequate venous access
boolean
C0023416 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0750164 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
consent to central catheter
Item
Willing to undergo insertion of a central catheter should leukapheresis via peripheral vein be inadequate
boolean
C2322576 (UMLS CUI [1,1])
C1511481 (UMLS CUI [1,2])
consent to second donation
Item
Agreeable to second donation of PBPC (or a bone marrow harvest) should the recipient fail to demonstrate sustained engraftment following the transplant
boolean
C0242602 (UMLS CUI [1,1])
C1517331 (UMLS CUI [1,2])
C1511481 (UMLS CUI [1,3])
informed consent donor
Item
Duly-executed informed consent
boolean
C0021430 (UMLS CUI [1])
CMV seroreactivity
Item
Screened for CMV seroreactivity
boolean
C0010823 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
Item Group
Exclusion Criteria Donor
C0680251 (UMLS CUI-1)
C0013018 (UMLS CUI-2)
active infection
Item
Evidence of active infection (including urinary tract infection, or upper respiratory tract infection)
boolean
C0009450 (UMLS CUI [1])
C0042029 (UMLS CUI [2])
C0041912 (UMLS CUI [3])
hepatitis donor
Item
Evidence of hepatitis (on screening)
boolean
C0019158 (UMLS CUI [1])
contraindications to growth factor therapy and leukapheresis
Item
Medical, physical or psychological reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0280112 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0023416 (UMLS CUI [2,3])
increased risk for leukapheresis or G-CSF-related complications
Item
Factors placing donor at increased risk for leukapheresis or G-CSF-related complications
boolean
C0035648 (UMLS CUI [1,1])
C0023416 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0079459 (UMLS CUI [2,2])
lactation and contraceptive use
Item
Lactating female, Female of child-bearing potential unwilling to implement adequate birth control
boolean
C2828358 (UMLS CUI [1])
C1999124 (UMLS CUI [2])
HIV positive donor
Item
HIV-positive
boolean
C0019699 (UMLS CUI [1])
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