ID

13996

Description

Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1208 in Acute Myelogenous Leukemia (AML) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01489722

Link

https://clinicaltrials.gov/show/NCT01489722

Keywords

  1. 3/21/16 3/21/16 -
Uploaded on

March 21, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT01489722

Eligibility Acute Myeloid Leukemia NCT01489722

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patients with relapsed or refractory acute myelogenous leukemia (aml) or aml secondary to myelodysplastic syndromes, myeloproliferative neoplasm, or chronic myelogenous leukemia
Description

Acute myelogenous leukemia in relapse

Data type

boolean

Alias
UMLS CUI [1]
C2367456
Eastern oncology cooperative group (ecog) performance status 0-2 and considered likely to complete at least 4 weeks of therapy
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
With the exception of alopecia, any unresolved toxicities from prior therapy greater than ctcae grade 1 at the time of starting study treatment.
Description

Mild Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1513302
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis b, hepatitis c and hiv.
Description

Systemic disease

Data type

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C2711110
UMLS CUI [3]
C0741554
Active heart disease including myocardial infarction within the last 3 months, symptomatic coronary artery disease, clinically significant arrhythmias not controlled by medication or uncontrolled congestive heart failure
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
Prior allogeneic transplant requiring immunosuppressive therapy (patients with prior allogeneic transplants who remain clinically stable for ≥ 2 weeks or more off immunosuppressive therapy, are eligible)
Description

Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
White blood cell count ≥ 100,000/mm3 (100x10*9/l)
Description

Total white blood count

Data type

boolean

Alias
UMLS CUI [1]
C1271681
type 1 diabetes or uncontrolled type ii diabetes
Description

DM 1

Data type

boolean

hba1c ≥8% or fasting blood glucose >160 mg/dl (>8.9 mmol/l)
Description

Hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Baseline fasting total cholesterol >300 mg/dl (>7.75 mmol/l)
Description

Total cholesterol

Data type

boolean

Alias
UMLS CUI [1]
C0543421

Similar models

Eligibility Acute Myeloid Leukemia NCT01489722

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Acute myelogenous leukemia in relapse
Item
Patients with relapsed or refractory acute myelogenous leukemia (aml) or aml secondary to myelodysplastic syndromes, myeloproliferative neoplasm, or chronic myelogenous leukemia
boolean
C2367456 (UMLS CUI [1])
ECOG performance status
Item
Eastern oncology cooperative group (ecog) performance status 0-2 and considered likely to complete at least 4 weeks of therapy
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mild Adverse Event
Item
With the exception of alopecia, any unresolved toxicities from prior therapy greater than ctcae grade 1 at the time of starting study treatment.
boolean
C1513302 (UMLS CUI [1])
Systemic disease
Item
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis b, hepatitis c and hiv.
boolean
C0442893 (UMLS CUI [1])
C2711110 (UMLS CUI [2])
C0741554 (UMLS CUI [3])
Heart Disease
Item
Active heart disease including myocardial infarction within the last 3 months, symptomatic coronary artery disease, clinically significant arrhythmias not controlled by medication or uncontrolled congestive heart failure
boolean
C0018799 (UMLS CUI [1])
Therapeutic immunosuppression
Item
Prior allogeneic transplant requiring immunosuppressive therapy (patients with prior allogeneic transplants who remain clinically stable for ≥ 2 weeks or more off immunosuppressive therapy, are eligible)
boolean
C0021079 (UMLS CUI [1])
Total white blood count
Item
White blood cell count ≥ 100,000/mm3 (100x10*9/l)
boolean
C1271681 (UMLS CUI [1])
DM 1
Item
type 1 diabetes or uncontrolled type ii diabetes
boolean
Hba1c
Item
hba1c ≥8% or fasting blood glucose >160 mg/dl (>8.9 mmol/l)
boolean
C0019018 (UMLS CUI [1])
Total cholesterol
Item
Baseline fasting total cholesterol >300 mg/dl (>7.75 mmol/l)
boolean
C0543421 (UMLS CUI [1])

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