ID

14171

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02029417

Trefwoorden

  1. 02-04-16 02-04-16 -
Geüploaded op

2 april 2016

DOI

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Licentie

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
Beschrijving

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
Beschrijving

Induction Chemotherapy

Datatype

boolean

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

diagnosis of acute myeloid leukemia

Datatype

boolean

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

Therapy naive

Datatype

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
Beschrijving

Contraceptive methods

Datatype

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
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Acute Promyelocytic Leukemia

Datatype

boolean

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

Protocol Compliance

Datatype

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
Beschrijving

Non-Compliance With Study Drug

Datatype

boolean

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

Sickle cell SC disease

Datatype

boolean

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

Investigational New Drugs

Datatype

boolean

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

Communicable Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0009450

Similar models

Eligibility Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome NCT02029417

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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