ID

13610

Descripción

Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00615784

Link

https://clinicaltrials.gov/show/NCT00615784

Palabras clave

Versiones (1)
  1. 19/2/16 19/2/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

19 de febrero de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00615784

Inglés

Eligibility Acute Myeloid Leukemia NCT00615784

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >= 18 years
Descripción

age >= 18 years

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
confirmed diagnosis of aml as proven by bone marrow biopsy
Descripción

confirmed diagnosis of aml as proven by bone marrow biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
must have received prior induction therapy with conventional chemotherapy and/or mylotarg or otherwise not eligible for conventional chemotherapy
Descripción

must have received prior induction therapy with conventional chemotherapy and/or mylotarg or otherwise not eligible for conventional chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0876099
ecog performance status of 0-2
Descripción

ecog performance status of 0-2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
recovered from toxicities of prior chemotherapy
Descripción

recovered from toxicities of prior chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2004454
UMLS CUI [1,2]
C0013221
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of pancreatitis
Descripción

history of pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
active alcohol abuse
Descripción

active alcohol abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
taken bexarotene in the past
Descripción

taken bexarotene in the past

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0765273
wbc > 10,000/ul at time of enrollment
Descripción

wbc > 10,000/ul at time of enrollment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose mylotarg
Descripción

cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose mylotarg

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0591617
UMLS CUI [3]
C0010711
UMLS CUI [4]
C0876099
significant organ disfunction: total bilirubin > 3x uln, ast or alt >3 x uln, creatinine > 3 mg/dl, on blood pressure supporting medications or mechanical ventilation
Descripción

significant organ disfunction: total bilirubin > 3x uln, ast or alt >3 x uln, creatinine > 3 mg/dl, on blood pressure supporting medications or mechanical ventilation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0199470
UMLS CUI [6,1]
C0005823
UMLS CUI [6,2]
C0013227
active participant in any other investigational treatment study for aml
Descripción

active participant in any other investigational treatment study for aml

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
life expectancy of less than 1 month
Descripción

life expectancy of less than 1 month

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
use of blood growth factors (g-csf, gm-csf, aranesp, erythropoietin, or neumega) within 1 week prior to treatment initiation
Descripción

use of blood growth factors (g-csf, gm-csf, aranesp, erythropoietin, or neumega) within 1 week prior to treatment initiation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0079460
UMLS CUI [3]
C1134440
UMLS CUI [4]
C0014822
UMLS CUI [5]
C0537668
uncontrolled hyperlipidemia
Descripción

uncontrolled hyperlipidemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020473
known history of hiv
Descripción

known history of hiv

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
known active cns involvement with aml
Descripción

known active cns involvement with aml

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0449389
UMLS CUI [1,2]
C0023467
women of childbearing potential or active breast feeding
Descripción

women of childbearing potential or active breast feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0006147
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Similar models

Eligibility Acute Myeloid Leukemia NCT00615784

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
aml
Item
confirmed diagnosis of aml as proven by bone marrow biopsy
boolean
C0023467 (UMLS CUI [1])
chemotherapy
Item
must have received prior induction therapy with conventional chemotherapy and/or mylotarg or otherwise not eligible for conventional chemotherapy
boolean
C0392920 (UMLS CUI [1])
C0876099 (UMLS CUI [2])
ecog
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
recovery from toxicity
Item
recovered from toxicities of prior chemotherapy
boolean
C2004454 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
alcohol abuse
Item
active alcohol abuse
boolean
C0038586 (UMLS CUI [1])
bexarotene
Item
taken bexarotene in the past
boolean
C0765273 (UMLS CUI [1])
wbc
Item
wbc > 10,000/ul at time of enrollment
boolean
C0023508 (UMLS CUI [1])
cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose mylotarg
Item
cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose mylotarg
boolean
C0677881 (UMLS CUI [1])
C0591617 (UMLS CUI [2])
C0010711 (UMLS CUI [3])
C0876099 (UMLS CUI [4])
organ disfunction
Item
significant organ disfunction: total bilirubin > 3x uln, ast or alt >3 x uln, creatinine > 3 mg/dl, on blood pressure supporting medications or mechanical ventilation
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0199470 (UMLS CUI [5])
C0005823 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
participation status
Item
active participant in any other investigational treatment study for aml
boolean
C2348568 (UMLS CUI [1])
life expectancy
Item
life expectancy of less than 1 month
boolean
C0023671 (UMLS CUI [1])
g-csf, gm-csf, aranesp, erythropoietin, or neumega
Item
use of blood growth factors (g-csf, gm-csf, aranesp, erythropoietin, or neumega) within 1 week prior to treatment initiation
boolean
C0079459 (UMLS CUI [1])
C0079460 (UMLS CUI [2])
C1134440 (UMLS CUI [3])
C0014822 (UMLS CUI [4])
C0537668 (UMLS CUI [5])
hyperlipidemia
Item
uncontrolled hyperlipidemia
boolean
C0020473 (UMLS CUI [1])
hiv
Item
known history of hiv
boolean
C0019682 (UMLS CUI [1])
cns involvement
Item
known active cns involvement with aml
boolean
C0449389 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
childbearing potential or active breast feeding
Item
women of childbearing potential or active breast feeding
boolean
C3831118 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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