ID

41121

Description

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

Keywords

Versions (1)
  1. 6/26/20 6/26/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 26, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Leukemia, Myeloid NCT01050036

English

Eligibility Leukemia, Myeloid NCT01050036

1 forms  
Inclusion Criteria
Description

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.
Description

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

Data type

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.
Description

Histone deacetylase inhibitor Chemotherapy cycle Planned

Data type

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
Description

Age

Data type

boolean

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

Karnofsky Performance Status

Data type

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).
Description

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

Data type

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)
Description

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

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of significant active infection
Description

Communicable Disease Significant

Data type

boolean

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

Bleeding uncontrolled

Data type

boolean

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

Comorbidity Major | Organ failure

Data type

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
Description

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

Data type

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
Description

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Unwilling

Data type

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)
Description

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

Data type

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
Back to the top of the page

Similar models

Eligibility Leukemia, Myeloid NCT01050036

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial