ID

13156

Beschreibung

A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00943553

Link

https://clinicaltrials.gov/show/NCT00943553

Stichworte

Versionen (1)
  1. 20.01.16 20.01.16 -
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CC BY-NC 3.0

Hochgeladen am

20. Januar 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia (AML) NCT00943553

Englisch

Eligibility Acute Myelogenous Leukemia (AML) NCT00943553

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males and females, age 1 to16 years, inclusive
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
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).
Beschreibung

pregnancy and contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
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).
Beschreibung

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
4. diagnosis of acute myelogenous leukemia (aml)(bone marrow or peripheral blood blasts ≥ 20%)
Beschreibung

AML diagnosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
5. adequate cardiac function as defined by an echocardiogram or multiple gated acquisition (muga) scan demonstrating an ejection fraction within normal limits
Beschreibung

cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
6. are willing and able to comply with all aspects of the protocol
Beschreibung

compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
7. provide written informed consent from subject's guardian or legally authorized representative and child assent (if applicable)
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. females who are pregnant (positive β-hcg test) or lactating
Beschreibung

pregnancy or lactation

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. history of chronic myelogenous leukemia (cml) [t(9;22)]
Beschreibung

CML

Datentyp

boolean

Alias
UMLS CUI [1]
C0023474
3. acute promyelocytic leukemia (m3 subtype in french-american-british [fab] classification).
Beschreibung

APL

Datentyp

boolean

Alias
UMLS CUI [1]
C0023487
4. known central nervous system (cns) leukemia
Beschreibung

cns leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C1332884
5. aml associated with congenital syndromes such as down syndrome, fanconi anemia, bloom syndrome, kostmann syndrome, or diamond blackfan anemia
Beschreibung

congenital syndromes

Datentyp

boolean

Alias
UMLS CUI [1]
C0013080
UMLS CUI [2]
C0015625
UMLS CUI [3]
C0005859
UMLS CUI [4]
C1853118
UMLS CUI [5]
C1260899
6. white blood cell (wbc) count > 40,000/mm3
Beschreibung

white blood cells

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
7. serum creatinine > 2.5 mg/dl
Beschreibung

creatinine

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
8. alanine aminotransferase (alt) > 5 x upper limit of normal (uln) and/or total bilirubin > 3 x uln
Beschreibung

bilirubin, ALT

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
9. prior chemotherapy (other than hydroxyurea) or radiation therapy for aml
Beschreibung

chemotherapy, radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
10. known to be human immunodeficiency virus (hiv) positive
Beschreibung

HIV

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
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
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
12. the investigator believes the subject to be medically unfit to receive the study drug or unsuitable for any other reason.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
13. subject with hypersensitivity to decitabine, daunorubicin, or cytarabine
Beschreibung

hypersensitivity to decitabine, daunorubicin, or cytarabine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0049065
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0011015
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0010711
14. has participated in a drug trial in the last 4 weeks
Beschreibung

has participated in a drug trial in the last 4 weeks

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Acute Myelogenous Leukemia (AML) NCT00943553

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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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