ID

15928

Beschrijving

PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron; ODM derived from: https://clinicaltrials.gov/show/NCT00037882

Link

https://clinicaltrials.gov/show/NCT00037882

Trefwoorden

Versies (1)
  1. 19-06-16 19-06-16 -
Geüploaded op

19 juni 2016

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Philadelphia-Positive NCT00037882

Engels

Eligibility Leukemia, Myeloid, Philadelphia-Positive NCT00037882

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic phase cml, documented by the presence of philadelphia chromosome or bcr/abl rearrangement at time of diagnosis, confirmed by either cytogenetics or pcr.
Beschrijving

philadelphia chromosome; bcr/abl rearrangement

Datatype

boolean

Alias
UMLS CUI [1]
C0031526
UMLS CUI [2]
C0004891
wbc >/= 3000/ul </=100,000/ul.
Beschrijving

wbc

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
patients must have received prior interferon therapy & proven to have primary refractory disease, secondary resistance or intolerance to interferon-a
Beschrijving

interferon therapy received; intolerance or secondary resistance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C1514815
UMLS CUI [2,1]
C0279030
UMLS CUI [2,2]
C0013203
UMLS CUI [2,3]
C1744706
patient must have ecog status of 0, 1, or 2
Beschrijving

ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
labs: sgot/sgpt<2xuln; serum bilirubin<2xuln; serum creatinine <2.0mg/dl
Beschrijving

sgot/sgpt; serum bilirubin; serum creatinine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0201899
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201976
recovered from effects of major surgery
Beschrijving

surgery recovery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2004454
life expectancy > 12 wks.
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
signed informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
women of childbearing potential must have negative serum pregnancy test within 72 hrs prior to administration of peg-intron & use effective contraception during the study.
Beschrijving

serum pregnancy test; contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0430060
UMLS CUI [2]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no accelerated phase cml patients with peripheral blood: blasts>/=15%, basophils>/=20%, blasts+promyelocytes>/=30%, platelets<100,000/ul (unrelated to therapy). blastic phase cml:>/=30% in peripheral blood/bone marrow.
Beschrijving

Blast Count; basophils; promyelocytes; platelets

Datatype

boolean

Alias
UMLS CUI [1]
C0523113
UMLS CUI [2]
C0200641
UMLS CUI [3]
C0455279
UMLS CUI [4]
C0032181
no patients with known hypersensitivity to interferon-a.
Beschrijving

interferon-a hypersensitivity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002199
no severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment or congestive heart failure (nyha classification iii/iv).
Beschrijving

severe cardiovascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
no history of neuropsychiatric disorder requiring hospitalization.
Beschrijving

neuropsychiatric disorder

Datatype

boolean

Alias
UMLS CUI [1]
C3203509
no patients requiring therapy for refractory thyroid dysfunction
Beschrijving

thyroid dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0348024
no patients with uncontrolled diabetes mellitus.
Beschrijving

uncontrolled diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0743113
no patients who have had treatment for a 2nd malignancy in the past 5 yrs, except for localized basal cell/squamous cell carcinoma of the skin or cervical carcinoma in situ.
Beschrijving

other malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
no pregnant or lactating patients.
Beschrijving

pregnancy; lactation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
no patients known to be actively using alcohol or drugs
Beschrijving

substance abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
no patients receiving any experimental therapy within 30 days of enrollment in study.
Beschrijving

experimental therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0949266
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Similar models

Eligibility Leukemia, Myeloid, Philadelphia-Positive NCT00037882

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
philadelphia chromosome; bcr/abl rearrangement
Item
chronic phase cml, documented by the presence of philadelphia chromosome or bcr/abl rearrangement at time of diagnosis, confirmed by either cytogenetics or pcr.
boolean
C0031526 (UMLS CUI [1])
C0004891 (UMLS CUI [2])
wbc
Item
wbc >/= 3000/ul </=100,000/ul.
boolean
C0023508 (UMLS CUI [1])
interferon therapy received; intolerance or secondary resistance
Item
patients must have received prior interferon therapy & proven to have primary refractory disease, secondary resistance or intolerance to interferon-a
boolean
C0279030 (UMLS CUI [1,1])
C1514815 (UMLS CUI [1,2])
C0279030 (UMLS CUI [2,1])
C0013203 (UMLS CUI [2,2])
C1744706 (UMLS CUI [2,3])
ecog
Item
patient must have ecog status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
sgot/sgpt; serum bilirubin; serum creatinine
Item
labs: sgot/sgpt<2xuln; serum bilirubin<2xuln; serum creatinine <2.0mg/dl
boolean
C0201836 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
surgery recovery
Item
recovered from effects of major surgery
boolean
C0543467 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
life expectancy
Item
life expectancy > 12 wks.
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
serum pregnancy test; contraception
Item
women of childbearing potential must have negative serum pregnancy test within 72 hrs prior to administration of peg-intron & use effective contraception during the study.
boolean
C0430060 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Blast Count; basophils; promyelocytes; platelets
Item
no accelerated phase cml patients with peripheral blood: blasts>/=15%, basophils>/=20%, blasts+promyelocytes>/=30%, platelets<100,000/ul (unrelated to therapy). blastic phase cml:>/=30% in peripheral blood/bone marrow.
boolean
C0523113 (UMLS CUI [1])
C0200641 (UMLS CUI [2])
C0455279 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
interferon-a hypersensitivity
Item
no patients with known hypersensitivity to interferon-a.
boolean
C0020517 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
severe cardiovascular disease
Item
no severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment or congestive heart failure (nyha classification iii/iv).
boolean
C0007222 (UMLS CUI [1])
neuropsychiatric disorder
Item
no history of neuropsychiatric disorder requiring hospitalization.
boolean
C3203509 (UMLS CUI [1])
thyroid dysfunction
Item
no patients requiring therapy for refractory thyroid dysfunction
boolean
C0348024 (UMLS CUI [1])
uncontrolled diabetes mellitus
Item
no patients with uncontrolled diabetes mellitus.
boolean
C0743113 (UMLS CUI [1])
other malignancy
Item
no patients who have had treatment for a 2nd malignancy in the past 5 yrs, except for localized basal cell/squamous cell carcinoma of the skin or cervical carcinoma in situ.
boolean
C0006826 (UMLS CUI [1])
pregnancy; lactation
Item
no pregnant or lactating patients.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
substance abuse
Item
no patients known to be actively using alcohol or drugs
boolean
C0038586 (UMLS CUI [1])
experimental therapy
Item
no patients receiving any experimental therapy within 30 days of enrollment in study.
boolean
C0949266 (UMLS CUI [1])
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