ID

14844

Description

A Study of the Histone-deacetylase Inhibitor JNJ-26481585 in Patients With Advanced or Refractory Leukemia or Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00676728

Link

https://clinicaltrials.gov/show/NCT00676728

Keywords

Versions (1)
  1. 5/1/16 5/1/16 -
Uploaded on

May 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Advanced or Refractory Leukemia NCT00676728

English

Eligibility Advanced or Refractory Leukemia NCT00676728

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed advanced or refractory acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia in blast phase, refractory chronic lymphocytic leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia
Description

acute myeloid leukemia, acute lymphocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023440
UMLS CUI [2]
C0023449
myelodysplastic syndrome
Description

myelodysplastic syndrome

Data type

boolean

Alias
UMLS CUI [1]
C3463824
eastern cooperative oncology group performance status score 0, 1 or 2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
left ventricular ejection fraction greater than or equal to 50%
Description

left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
negative hepatitis b, c and human immunodeficiency virus (hiv) test within last 3 months
Description

negative hepatitis b, c and human immunodeficiency virus (hiv)

Data type

boolean

Alias
UMLS CUI [1]
C2711110
UMLS CUI [2]
C0019693
adequate liver and kidney function
Description

liver and kidney function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected involvement of the central nervous system
Description

involvement of the central nervous system

Data type

boolean

Alias
UMLS CUI [1]
C0449389
chemotherapy (nitrosoureas and mitomycin c within 6 weeks), radiotherapy, immunotherapy or treatment with investigative agent within 3 weeks before study drug administration (except hydroxyurea which should be stopped at least 24 hours prior to first dose)
Description

chemotherapy, radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure
Description

unstable angina or myocardial infarction, congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
poorly controlled hypertension or diabetes, ongoing active infection and psychiatric illness
Description

hypertension or diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0020538
receiving medications known to have a risk of causing qtc prolongation
Description

qtc prolongation

Data type

boolean

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Similar models

Eligibility Advanced or Refractory Leukemia NCT00676728

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
acute myeloid leukemia, acute lymphocytic leukemia
Item
histologically or cytologically confirmed advanced or refractory acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia in blast phase, refractory chronic lymphocytic leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia
boolean
C0023440 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
myelodysplastic syndrome
Item
myelodysplastic syndrome
boolean
C3463824 (UMLS CUI [1])
ecog
Item
eastern cooperative oncology group performance status score 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
left ventricular ejection fraction
Item
left ventricular ejection fraction greater than or equal to 50%
boolean
C0428772 (UMLS CUI [1])
negative hepatitis b, c and human immunodeficiency virus (hiv)
Item
negative hepatitis b, c and human immunodeficiency virus (hiv) test within last 3 months
boolean
C2711110 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
liver and kidney function
Item
adequate liver and kidney function
boolean
C0232741 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
involvement of the central nervous system
Item
known or suspected involvement of the central nervous system
boolean
C0449389 (UMLS CUI [1])
chemotherapy, radiotherapy
Item
chemotherapy (nitrosoureas and mitomycin c within 6 weeks), radiotherapy, immunotherapy or treatment with investigative agent within 3 weeks before study drug administration (except hydroxyurea which should be stopped at least 24 hours prior to first dose)
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
unstable angina or myocardial infarction, congestive heart failure
Item
unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure
boolean
C0018802 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
hypertension or diabetes
Item
poorly controlled hypertension or diabetes, ongoing active infection and psychiatric illness
boolean
C0020538 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
qtc prolongation
Item
receiving medications known to have a risk of causing qtc prolongation
boolean
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