ID

13610

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00615784

Nyckelord

  1. 2016-02-19 2016-02-19 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

19 februari 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Acute Myeloid Leukemia NCT00615784

Eligibility Acute Myeloid Leukemia NCT00615784

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >= 18 years
Beskrivning

age >= 18 years

Datatyp

boolean

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

confirmed diagnosis of aml as proven by bone marrow biopsy

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

ecog performance status of 0-2

Datatyp

boolean

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

recovered from toxicities of prior chemotherapy

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of pancreatitis
Beskrivning

history of pancreatitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0030305
active alcohol abuse
Beskrivning

active alcohol abuse

Datatyp

boolean

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

taken bexarotene in the past

Datatyp

boolean

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

wbc > 10,000/ul at time of enrollment

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

active participant in any other investigational treatment study for aml

Datatyp

boolean

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

life expectancy of less than 1 month

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

uncontrolled hyperlipidemia

Datatyp

boolean

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

known history of hiv

Datatyp

boolean

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

known active cns involvement with aml

Datatyp

boolean

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

women of childbearing potential or active breast feeding

Datatyp

boolean

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

Similar models

Eligibility Acute Myeloid Leukemia NCT00615784

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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