ID

41121

Beschrijving

Autologous Hematopoietic Cell Transplantation for Core-binding Factor Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01050036

Link

https://clinicaltrials.gov/show/NCT01050036

Trefwoorden

Versies (1)
  1. 26-06-20 26-06-20 -
Houder van rechten

See clinicaltrials.gov

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26 juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid NCT01050036

Engels

Eligibility Leukemia, Myeloid NCT01050036

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with cbf positive aml in cr1. cbf aml includes t(8;21)(q22;q22) [aml1(runx1)/eto(cbfα2t1)], inv(16)(q13q22) (cbfβ/myh11), t(16;16)(p13;q22) (cbfβ/myh11) using rt-pcr, fish, or standard karyotype analysis technique.
Beschrijving

Core binding factor acute myeloid leukemia In complete remission First | t(8;21)(q22;q22) | AML1-ETO fusion protein, human | Other Coding | Acute myeloid leukemia with abnormal marrow eosinophils | t(16;16)(p13.1;q22) | Reverse Transcriptase Polymerase Chain Reaction | FISH | Karyotype determination procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C3839741
UMLS CUI [1,2]
C0677874
UMLS CUI [1,3]
C0205435
UMLS CUI [2]
C1515794
UMLS CUI [3]
C0665119
UMLS CUI [4]
C3846158
UMLS CUI [5]
C0522630
UMLS CUI [6]
C2828339
UMLS CUI [7]
C0599161
UMLS CUI [8]
C0162789
UMLS CUI [9]
C0022526
patients who plan to receive the second cycle of hdac consolidation chemotherapy.
Beschrijving

Histone deacetylase inhibitor Chemotherapy cycle Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C4724018
UMLS CUI [1,2]
C1302181
UMLS CUI [1,3]
C1301732
15 years old or older and 65 years or younger
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
adequate performance status (karnofsky score of 70 or more).
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
adequate hepatic and renal function (ast, alt, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dl).
Beschrijving

Liver function | Renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201976
adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography)
Beschrijving

Cardiac function | Left ventricular ejection fraction Heart scan | Left ventricular ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C2500064
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0013516
signed and dated informed consent must be obtained from patient.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of significant active infection
Beschrijving

Communicable Disease Significant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0750502
presence of uncontrolled bleeding
Beschrijving

Bleeding uncontrolled

Datatype

boolean

Alias
UMLS CUI [1]
C3842135
any coexisting major illness or organ failure
Beschrijving

Comorbidity Major | Organ failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0349410
patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
Beschrijving

Mental disorders | Mental deficiency Severe | Treatment Compliance Unlikely | Informed Consent Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0917816
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C4319828
UMLS CUI [3,2]
C0750558
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1272705
nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
Beschrijving

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Beschrijving

Malignant Neoplasm Previous | Exception Disease Free | Status post Curative treatment | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in Situ | Exception Curative treatment Cervical Intraepithelial Neoplasia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1273390
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0699893
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C0007099
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1273390
UMLS CUI [6,3]
C0206708
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Similar models

Eligibility Leukemia, Myeloid NCT01050036

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Core binding factor acute myeloid leukemia In complete remission First | t(8;21)(q22;q22) | AML1-ETO fusion protein, human | Other Coding | Acute myeloid leukemia with abnormal marrow eosinophils | t(16;16)(p13.1;q22) | Reverse Transcriptase Polymerase Chain Reaction | FISH | Karyotype determination procedure
Item
patients with cbf positive aml in cr1. cbf aml includes t(8;21)(q22;q22) [aml1(runx1)/eto(cbfα2t1)], inv(16)(q13q22) (cbfβ/myh11), t(16;16)(p13;q22) (cbfβ/myh11) using rt-pcr, fish, or standard karyotype analysis technique.
boolean
C3839741 (UMLS CUI [1,1])
C0677874 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C1515794 (UMLS CUI [2])
C0665119 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
C0522630 (UMLS CUI [5])
C2828339 (UMLS CUI [6])
C0599161 (UMLS CUI [7])
C0162789 (UMLS CUI [8])
C0022526 (UMLS CUI [9])
Histone deacetylase inhibitor Chemotherapy cycle Planned
Item
patients who plan to receive the second cycle of hdac consolidation chemotherapy.
boolean
C4724018 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Age
Item
15 years old or older and 65 years or younger
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
adequate performance status (karnofsky score of 70 or more).
boolean
C0206065 (UMLS CUI [1])
Liver function | Renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
adequate hepatic and renal function (ast, alt, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dl).
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Cardiac function | Left ventricular ejection fraction Heart scan | Left ventricular ejection fraction Echocardiography
Item
adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography)
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C2500064 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
Informed Consent
Item
signed and dated informed consent must be obtained from patient.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Disease Significant
Item
presence of significant active infection
boolean
C0009450 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Bleeding uncontrolled
Item
presence of uncontrolled bleeding
boolean
C3842135 (UMLS CUI [1])
Comorbidity Major | Organ failure
Item
any coexisting major illness or organ failure
boolean
C0009488 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0349410 (UMLS CUI [2])
Mental disorders | Mental deficiency Severe | Treatment Compliance Unlikely | Informed Consent Unsuccessful
Item
patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
boolean
C0004936 (UMLS CUI [1])
C0917816 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4319828 (UMLS CUI [3,1])
C0750558 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling
Item
nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Malignant Neoplasm Previous | Exception Disease Free | Status post Curative treatment | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in Situ | Exception Curative treatment Cervical Intraepithelial Neoplasia
Item
patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0699893 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0007099 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])
C0206708 (UMLS CUI [6,3])
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