ID

41126

Description

Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01001143

Link

https://clinicaltrials.gov/show/NCT01001143

Keywords

Versions (1)
  1. 6/27/20 6/27/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 27, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT01001143

English

Eligibility Leukemia, Myeloid, Acute NCT01001143

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aml with bone marrow blasts ≥ 20%.
Description

Leukemia, Myelocytic, Acute | Blast cells in bone marrow Percentage

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C4539635
UMLS CUI [2,2]
C0439165
relapsed disease after 1 or more lines of prior salvage chemotherapy and any fab-aml, or
Description

Recurrent disease | Status post Prior Chemotherapy Quantity | AML FAB Classification

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1514457
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C2984084
diagnosis of aml and age ≥ 60 and not a candidate for cytotoxic chemotherapy and any fab-aml except fab-m3.
Description

AML FAB Classification | Exception Acute Promyelocytic Leukemia | Age | Patient Inappropriate Cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C2984084
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023487
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0677881
performance status ≤ 2.
Description

Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
age ≥ 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
peripheral white blood cell count (wbc) > 10,000/microliter.
Description

White Blood Cell Count Peripheral blood

Data type

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0229664
total bilirubin > 1.5 x normal.
Description

SERUM TOTAL BILIRUBIN ELEVATED

Data type

boolean

Alias
UMLS CUI [1]
C0595866
ast/alt > 2.5 x normal.
Description

Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
serum creatinine > 2 x normal.
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
fasting serum triglyceride > 1,000 mg/dl.
Description

Serum fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0582824
active or poorly controlled graft vs host disease (gvhd).
Description

Graft-vs-Host Disease | Graft-vs-Host Disease Poorly controlled

Data type

boolean

Alias
UMLS CUI [1]
C0018133
UMLS CUI [2,1]
C0018133
UMLS CUI [2,2]
C3853134
pregnant or nursing.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known cns leukemia.
Description

Central nervous system leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
history of positive hiv serology.
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
history of positive hepatitis c serology.
Description

Serology positive Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019196
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure of nyha class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
chemotherapy within 21 days of enrollment.
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
radiation therapy within 14 days of enrollment.
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
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Similar models

Eligibility Leukemia, Myeloid, Acute NCT01001143

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute | Blast cells in bone marrow Percentage
Item
aml with bone marrow blasts ≥ 20%.
boolean
C0023467 (UMLS CUI [1])
C4539635 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Recurrent disease | Status post Prior Chemotherapy Quantity | AML FAB Classification
Item
relapsed disease after 1 or more lines of prior salvage chemotherapy and any fab-aml, or
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0023467 (UMLS CUI [3,1])
C2984084 (UMLS CUI [3,2])
AML FAB Classification | Exception Acute Promyelocytic Leukemia | Age | Patient Inappropriate Cytotoxic Chemotherapy
Item
diagnosis of aml and age ≥ 60 and not a candidate for cytotoxic chemotherapy and any fab-aml except fab-m3.
boolean
C0023467 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0023487 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0677881 (UMLS CUI [4,3])
Performance Status
Item
performance status ≤ 2.
boolean
C1518965 (UMLS CUI [1])
Age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
White Blood Cell Count Peripheral blood
Item
peripheral white blood cell count (wbc) > 10,000/microliter.
boolean
C0023508 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
SERUM TOTAL BILIRUBIN ELEVATED
Item
total bilirubin > 1.5 x normal.
boolean
C0595866 (UMLS CUI [1])
Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased
Item
ast/alt > 2.5 x normal.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum creatinine raised
Item
serum creatinine > 2 x normal.
boolean
C0700225 (UMLS CUI [1])
Serum fasting triglyceride measurement
Item
fasting serum triglyceride > 1,000 mg/dl.
boolean
C0582824 (UMLS CUI [1])
Graft-vs-Host Disease | Graft-vs-Host Disease Poorly controlled
Item
active or poorly controlled graft vs host disease (gvhd).
boolean
C0018133 (UMLS CUI [1])
C0018133 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Central nervous system leukemia
Item
known cns leukemia.
boolean
C1332884 (UMLS CUI [1])
HIV Seropositivity
Item
history of positive hiv serology.
boolean
C0019699 (UMLS CUI [1])
Serology positive Hepatitis C
Item
history of positive hepatitis c serology.
boolean
C0242089 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure of nyha class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Chemotherapy
Item
chemotherapy within 21 days of enrollment.
boolean
C0392920 (UMLS CUI [1])
Therapeutic radiology procedure
Item
radiation therapy within 14 days of enrollment.
boolean
C1522449 (UMLS CUI [1])
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