ID

13248

Description

Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic (MD) Syndrome With Laromustine and Infusional Cytarabine; ODM derived from: https://clinicaltrials.gov/show/NCT00655395

Link

https://clinicaltrials.gov/show/NCT00655395

Keywords

Versions (1)
  1. 1/26/16 1/26/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 26, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia (AML) NCT00655395

English

Eligibility Acute Myeloid Leukemia (AML) NCT00655395

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of aml based on who criteria (greater than 20% blasts in the bone marrow or blood) excluding aml m3, acute promyelocytic leukemia or diagnosis of high-risk mds defined as international prognostic scoring system int-2.
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
ecog performance status equal to 0, 1, 2.
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
no prior treatment for aml with myeloablative treatment. patients may have prior treatment with a biologic therapy. patients with mds or aml that has evolved from mds could have received prior low-dose cytotoxic therapy with agents such as azacytidine or low-dose ara c.
Description

prior treatment

Data type

boolean

Alias
UMLS CUI [1]
C0087111
ability to sign an informed consent according to institutional guidelines.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must have the following clinical laboratory values within 24 hours prior to beginning protocol treatment: a) serum creatinine less than or equal to 2.0mg/dl. b) total bilirubin less than or equal to 2.0 mg/dl c) alt or ast less than or equal to 5 times the upper limit of normal.
Description

laboratory values

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled active infection. patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered into the study. patients with chronic hepatitis are eligible.
Description

active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
active heart disease including myocardial infarction, symptomatic coronary artery disease, arrhythmias not controlled by medication or uncontrolled congestive heart failure.
Description

heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
severe pulmonary disease not controlled with medication.
Description

pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
patients with serum creatinine > 2.0, serum bilirubin > 2.0. alt or ast greater that 5 times the upper limit of normal. patients with bilirubin or creatinine outside the acceptable levels will be considered eligible if this abnormality is clearly leukemia related and discussed with the principal's investigator prior to enrollment.
Description

patients with serum creatinine > 2.0, serum bilirubin > 2.0. alt or ast greater that 5 times the upper limit of normal

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
patients concurrently receiving any other standard or investigational treatment for leukemia with the exception of hydroxyurea.
Description

patients concurrently receiving any other standard or investigational treatment for leukemia with the exception of hydroxyurea

Data type

boolean

Alias
UMLS CUI [1]
C1875319
since the formulation contains 30% ethanol, patients being treated with antabuse (disulfiram) are excluded from the study.
Description

disulfiram

Data type

boolean

Alias
UMLS CUI [1]
C0012772
patients with apl t(15;17)
Description

APL

Data type

boolean

Alias
UMLS CUI [1]
C0023487
patients with ecog performance status of 3 or 4.
Description

ecog performance status of 3 or 4

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients should be off metronidazole (flagyl) at least 24 hours before starting laromustine.
Description

metronidazole

Data type

boolean

Alias
UMLS CUI [1]
C0025872
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Similar models

Eligibility Acute Myeloid Leukemia (AML) NCT00655395

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
diagnosis of aml based on who criteria (greater than 20% blasts in the bone marrow or blood) excluding aml m3, acute promyelocytic leukemia or diagnosis of high-risk mds defined as international prognostic scoring system int-2.
boolean
C0023467 (UMLS CUI [1])
ECOG
Item
ecog performance status equal to 0, 1, 2.
boolean
C1520224 (UMLS CUI [1])
prior treatment
Item
no prior treatment for aml with myeloablative treatment. patients may have prior treatment with a biologic therapy. patients with mds or aml that has evolved from mds could have received prior low-dose cytotoxic therapy with agents such as azacytidine or low-dose ara c.
boolean
C0087111 (UMLS CUI [1])
informed consent
Item
ability to sign an informed consent according to institutional guidelines.
boolean
C0021430 (UMLS CUI [1])
laboratory values
Item
patients must have the following clinical laboratory values within 24 hours prior to beginning protocol treatment: a) serum creatinine less than or equal to 2.0mg/dl. b) total bilirubin less than or equal to 2.0 mg/dl c) alt or ast less than or equal to 5 times the upper limit of normal.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
active infection
Item
uncontrolled active infection. patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered into the study. patients with chronic hepatitis are eligible.
boolean
C0009450 (UMLS CUI [1])
heart disease
Item
active heart disease including myocardial infarction, symptomatic coronary artery disease, arrhythmias not controlled by medication or uncontrolled congestive heart failure.
boolean
C0018799 (UMLS CUI [1])
pulmonary disease
Item
severe pulmonary disease not controlled with medication.
boolean
C0024115 (UMLS CUI [1])
patients with serum creatinine > 2.0, serum bilirubin > 2.0. alt or ast greater that 5 times the upper limit of normal
Item
patients with serum creatinine > 2.0, serum bilirubin > 2.0. alt or ast greater that 5 times the upper limit of normal. patients with bilirubin or creatinine outside the acceptable levels will be considered eligible if this abnormality is clearly leukemia related and discussed with the principal's investigator prior to enrollment.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
patients concurrently receiving any other standard or investigational treatment for leukemia with the exception of hydroxyurea
Item
patients concurrently receiving any other standard or investigational treatment for leukemia with the exception of hydroxyurea.
boolean
C1875319 (UMLS CUI [1])
disulfiram
Item
since the formulation contains 30% ethanol, patients being treated with antabuse (disulfiram) are excluded from the study.
boolean
C0012772 (UMLS CUI [1])
APL
Item
patients with apl t(15;17)
boolean
C0023487 (UMLS CUI [1])
ecog performance status of 3 or 4
Item
patients with ecog performance status of 3 or 4.
boolean
C1520224 (UMLS CUI [1])
metronidazole
Item
patients should be off metronidazole (flagyl) at least 24 hours before starting laromustine.
boolean
C0025872 (UMLS CUI [1])
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