ID

14171

Beskrivning

Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02029417

Länk

https://clinicaltrials.gov/show/NCT02029417

Nyckelord

  1. 2016-04-02 2016-04-02 -
Uppladdad den

2 april 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome NCT02029417

Eligibility Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome NCT02029417

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are not eligible for standard induction chemotherapy (or any standard therapy known to be life prolonging) because of poor performance status, significant tissue comorbidities, or unfavorable risk of disease
Beskrivning

Induction Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C3179010
have an unequivocal histologic diagnosis of acute myeloid leukemia (aml) (including secondary aml)
Beskrivning

diagnosis of acute myeloid leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
no prior therapy for aml except hydroxyurea to control counts
Beskrivning

Therapy naive

Datatyp

boolean

Alias
UMLS CUI [1]
C0919936
must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with the diagnosis of acute promyelocytic leukemia (t[15;17])
Beskrivning

Acute Promyelocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
unwilling or unable to follow protocol requirements
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0009488
any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
Beskrivning

Non-Compliance With Study Drug

Datatyp

boolean

Alias
UMLS CUI [1]
C1709261
patients with sickle cell disease and sickle cell crisis
Beskrivning

Sickle cell SC disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0853729
received an investigational agent for another disease within 30 days prior to enrollment
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
the patient has an uncontrolled and active infection that would preclude study conduct and assessment
Beskrivning

Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450

Similar models

Eligibility Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome NCT02029417

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Induction Chemotherapy
Item
patients who are not eligible for standard induction chemotherapy (or any standard therapy known to be life prolonging) because of poor performance status, significant tissue comorbidities, or unfavorable risk of disease
boolean
C3179010 (UMLS CUI [1])
diagnosis of acute myeloid leukemia
Item
have an unequivocal histologic diagnosis of acute myeloid leukemia (aml) (including secondary aml)
boolean
C0023467 (UMLS CUI [1])
Therapy naive
Item
no prior therapy for aml except hydroxyurea to control counts
boolean
C0919936 (UMLS CUI [1])
Contraceptive methods
Item
must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
subjects with the diagnosis of acute promyelocytic leukemia (t[15;17])
boolean
C0023487 (UMLS CUI [1])
Protocol Compliance
Item
unwilling or unable to follow protocol requirements
boolean
C0525058 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Non-Compliance With Study Drug
Item
any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
boolean
C1709261 (UMLS CUI [1])
Sickle cell SC disease
Item
patients with sickle cell disease and sickle cell crisis
boolean
C0853729 (UMLS CUI [1])
Investigational New Drugs
Item
received an investigational agent for another disease within 30 days prior to enrollment
boolean
C0013230 (UMLS CUI [1])
Communicable Diseases
Item
the patient has an uncontrolled and active infection that would preclude study conduct and assessment
boolean
C0009450 (UMLS CUI [1])

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