ID

13752

Beschreibung

Autologous Hematopoietic Cell Transplantation for Core-binding Factor (CBF) Acute Myeloid Leukemia (AML) in the First Complete Remission (CR1); ODM derived from: https://clinicaltrials.gov/show/NCT01146977

Link

https://clinicaltrials.gov/show/NCT01146977

Stichworte

Versionen (1)
  1. 03.03.16 03.03.16 -
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CC BY-NC 3.0

Hochgeladen am

3. März 2016

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Eligibility Acute Myeloid Leukemia NCT01146977

Englisch

Eligibility Acute Myeloid Leukemia NCT01146977

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0212320
UMLS CUI [1,3]
C0677874
patients who plan to receive the second cycle of hdac consolidation chemotherapy.
Beschreibung

ID.2

Datentyp

boolean

15 years old or older and 65 years or younger
Beschreibung

15 years old or older and 65 years or younger

Datentyp

boolean

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

adequate performance status (karnofsky score of 70 or more).

Datentyp

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).
Beschreibung

adequate hepatic and renal function (ast, alt, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dl).

Datentyp

boolean

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

adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography)

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
signed and dated informed consent must be obtained from patient.
Beschreibung

signed and dated informed consent must be obtained from patient.

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of significant active infection
Beschreibung

presence of significant active infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
presence of uncontrolled bleeding
Beschreibung

presence of uncontrolled bleeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0019080
any coexisting major illness or organ failure
Beschreibung

any coexisting major illness or organ failure

Datentyp

boolean

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

patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
Beschreibung

nursing women, pregnant women, women of childbearing potential who do not want adequate contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0700589
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)
Beschreibung

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)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332152
UMLS CUI [2]
C0007099
UMLS CUI [3]
C0699893
UMLS CUI [4]
C0206708
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Ähnliche Modelle

Eligibility Acute Myeloid Leukemia NCT01146977

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
aml in complete remission
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
C0023467 (UMLS CUI [1,1])
C0212320 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,3])
ID.2
Item
patients who plan to receive the second cycle of hdac consolidation chemotherapy.
boolean
age
Item
15 years old or older and 65 years or younger
boolean
C0001779 (UMLS CUI [1])
karnofsky
Item
adequate performance status (karnofsky score of 70 or more).
boolean
C0206065 (UMLS CUI [1])
hepatic and renal function
Item
adequate hepatic and renal function (ast, alt, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dl).
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
LVEF
Item
adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography)
boolean
C0428772 (UMLS CUI [1])
informed consent
Item
signed and dated informed consent must be obtained from patient.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
active infection
Item
presence of significant active infection
boolean
C0009450 (UMLS CUI [1])
bleeding
Item
presence of uncontrolled bleeding
boolean
C0019080 (UMLS CUI [1])
comorbidity
Item
any coexisting major illness or organ failure
boolean
C0009488 (UMLS CUI [1])
comorbidity limiting study protocol
Item
patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
nursing, pregnancy, contraception
Item
nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
prior malignancy
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])
C0332152 (UMLS CUI [1,2])
C0007099 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
C0206708 (UMLS CUI [4])
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