Eligibility Acute Myeloid Leukemia NCT02462265

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients is diagnosed as aml or all
Beschrijving

aml or all

Datatype

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0023449
relapse defined as the presence of disease after the achievement of complete remission(cr). refractory disease is defined as progression from or no response while treated with a previous line chemotherapy regimen, or progression within 30 days of last bone marrow assessment.
Beschrijving

Relapse AML

Datatype

boolean

Alias
UMLS CUI [1]
C2367456
male or female ≥ 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
minimal performance status (ecog 0, ≤2)
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
patients must have a measurable disease by bone marrow blast counts of > 5 % of nucleated cells.
Beschrijving

bone marrow blast count

Datatype

boolean

Alias
UMLS CUI [1]
C2697913
written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
adequate hepatic function (lfts up to x4 the normal limits), renal function calculated creatinine clearance (crcl) for adverse effects of >30)
Beschrijving

Liver and renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
ability to swallow the medications.
Beschrijving

Ability to swallow tablet

Datatype

boolean

Alias
UMLS CUI [1]
C3838726
females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
Beschrijving

Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infectious disease uncontrolled by antibiotics.
Beschrijving

Communicable Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
partially treated induction patients (i.e. day 14 non responding patients).
Beschrijving

Induction patients

Datatype

boolean

Alias
UMLS CUI [1]
C0205263
Inability to receive high dose salvage chemotherapy.
Beschrijving

Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C3665472
patient with known positive hiv serology at screening.
Beschrijving

HIV Seropositivity

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
Beschrijving

Breastfeeding

Datatype

boolean

Alias
UMLS CUI [1]
C1623040
UMLS CUI [2]
C0240802
evidence of ongoing cardiac dysrhythmias of nci common toxicity criteria for adverse effects (ctcae ) version 3.0 grade 2.
Beschrijving

Cardiac Arrhythmia

Datatype

boolean

Alias
UMLS CUI [1]
C0003811
pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
Beschrijving

Malabsorption Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0022104
mental disorders
Beschrijving

mental disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
inability to give written informed consent
Beschrijving

No written consent

Datatype

boolean

Alias
UMLS CUI [1]
C0811746

Similar models

Eligibility Acute Myeloid Leukemia NCT02462265

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
aml or all
Item
patients is diagnosed as aml or all
boolean
C0023467 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
Relapse AML
Item
relapse defined as the presence of disease after the achievement of complete remission(cr). refractory disease is defined as progression from or no response while treated with a previous line chemotherapy regimen, or progression within 30 days of last bone marrow assessment.
boolean
C2367456 (UMLS CUI [1])
Age
Item
male or female ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
minimal performance status (ecog 0, ≤2)
boolean
C1520224 (UMLS CUI [1])
bone marrow blast count
Item
patients must have a measurable disease by bone marrow blast counts of > 5 % of nucleated cells.
boolean
C2697913 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Liver and renal function
Item
adequate hepatic function (lfts up to x4 the normal limits), renal function calculated creatinine clearance (crcl) for adverse effects of >30)
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Ability to swallow tablet
Item
ability to swallow the medications.
boolean
C3838726 (UMLS CUI [1])
Contraceptive methods
Item
females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
boolean
C0700589 (UMLS CUI [1])
Pregnancy test negative
Item
females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Diseases
Item
active infectious disease uncontrolled by antibiotics.
boolean
C0009450 (UMLS CUI [1])
Induction patients
Item
partially treated induction patients (i.e. day 14 non responding patients).
boolean
C0205263 (UMLS CUI [1])
Chemotherapy
Item
Inability to receive high dose salvage chemotherapy.
boolean
C3665472 (UMLS CUI [1])
HIV Seropositivity
Item
patient with known positive hiv serology at screening.
boolean
C0019699 (UMLS CUI [1])
Breastfeeding
Item
female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
boolean
C1623040 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
Cardiac Arrhythmia
Item
evidence of ongoing cardiac dysrhythmias of nci common toxicity criteria for adverse effects (ctcae ) version 3.0 grade 2.
boolean
C0003811 (UMLS CUI [1])
Malabsorption Syndrome
Item
pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
boolean
C0024523 (UMLS CUI [1])
C0022104 (UMLS CUI [2])
mental disorders
Item
mental disorders
boolean
C0004936 (UMLS CUI [1])
No written consent
Item
inability to give written informed consent
boolean
C0811746 (UMLS CUI [1])