Eligibility Acute Myelogenous Leukemia (AML) NCT00943553

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StudyEvent: Eligibility
1. Eligibility Acute Myelogenous Leukemia (AML) NCT00943553

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

age

Item

1. males and females, age 1 to16 years, inclusive

boolean

C0001779 (UMLS CUI [1])

pregnancy and contraception

Item

2. females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hcg) at visit 1 (screening) and a negative urine pregnancy test prior to starting study drugs (visit 2). female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine devise (iud), or have a vasectomised partner) for at least one menstrual cycle prior to starting study drug(s) and throughout the longer of either core study period or 30 days after the last dose of study drug. those females using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).

boolean

C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])

contraception

Item

3. sexually mature male patients who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, iud) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).

boolean

C0700589 (UMLS CUI [1])

AML diagnosis

Item

4. diagnosis of acute myelogenous leukemia (aml)(bone marrow or peripheral blood blasts ≥ 20%)

boolean

C0023467 (UMLS CUI [1])

cardiac function

Item

5. adequate cardiac function as defined by an echocardiogram or multiple gated acquisition (muga) scan demonstrating an ejection fraction within normal limits

boolean

C0232174 (UMLS CUI [1])

compliance

Item

6. are willing and able to comply with all aspects of the protocol

boolean

C1321605 (UMLS CUI [1])

informed consent

Item

7. provide written informed consent from subject's guardian or legally authorized representative and child assent (if applicable)

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

pregnancy or lactation

Item

1. females who are pregnant (positive β-hcg test) or lactating

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

CML

Item

2. history of chronic myelogenous leukemia (cml) [t(9;22)]

boolean

C0023474 (UMLS CUI [1])

APL

Item

3. acute promyelocytic leukemia (m3 subtype in french-american-british [fab] classification).

boolean

C0023487 (UMLS CUI [1])

cns leukemia

Item

4. known central nervous system (cns) leukemia

boolean

C1332884 (UMLS CUI [1])

congenital syndromes

Item

5. aml associated with congenital syndromes such as down syndrome, fanconi anemia, bloom syndrome, kostmann syndrome, or diamond blackfan anemia

boolean

C0013080 (UMLS CUI [1])
C0015625 (UMLS CUI [2])
C0005859 (UMLS CUI [3])
C1853118 (UMLS CUI [4])
C1260899 (UMLS CUI [5])

white blood cells

Item

6. white blood cell (wbc) count > 40,000/mm3

boolean

C0023508 (UMLS CUI [1])

creatinine

Item

7. serum creatinine > 2.5 mg/dl

boolean

C0201976 (UMLS CUI [1])

bilirubin, ALT

Item

8. alanine aminotransferase (alt) > 5 x upper limit of normal (uln) and/or total bilirubin > 3 x uln

boolean

C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])

chemotherapy, radiation

Item

9. prior chemotherapy (other than hydroxyurea) or radiation therapy for aml

boolean

C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])

HIV

Item

10. known to be human immunodeficiency virus (hiv) positive

boolean

C0019682 (UMLS CUI [1])

any history of or concomitant medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study

Item

11. any history of or concomitant medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study

boolean

C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

the investigator believes the subject to be medically unfit to receive the study drug or unsuitable for any other reason

Item

12. the investigator believes the subject to be medically unfit to receive the study drug or unsuitable for any other reason.

boolean

C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

hypersensitivity to decitabine, daunorubicin, or cytarabine

Item

13. subject with hypersensitivity to decitabine, daunorubicin, or cytarabine

boolean

C0020517 (UMLS CUI [1,1])
C0049065 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0011015 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0010711 (UMLS CUI [3,2])

has participated in a drug trial in the last 4 weeks

Item

14. has participated in a drug trial in the last 4 weeks

boolean

C2348568 (UMLS CUI [1])

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Eligibility Acute Myelogenous Leukemia (AML) NCT00943553