ID

14127

Descrizione

Peginterferon Alfa-2a to Enhance Anti-leukemic Responses After Allogeneic Transplantation in Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02328755

collegamento

https://clinicaltrials.gov/show/NCT02328755

Keywords

versioni (1)
  1. 30/03/16 30/03/16 -
Caricato su

30 marzo 2016

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02328755

Inglese

Eligibility Acute Myeloid Leukemia NCT02328755

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have aml not in remission or at very high risk for hct (hematopoietic cell transplantation) relapse.
Descrizione

AML

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0153886
for newly diagnosed aml, patients must have achieved two consecutive induction attempts without achieving complete remission
Descrizione

induction attempts

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1514832
for patients initially in complete remission whose aml relapses > 6 months after preceding remission, one re-induction must be attempted to be eligible
Descrizione

aml relapse

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2367456
for aml patients with early relapse, in whom the preceding remission is shorter than 6 months duration, no re-induction regimen is necessary to be eligible
Descrizione

re-induction regimen

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0153886
patients with antecedent mds (myelodysplastic syndrome) who progress to aml may have therapies rendered during both phases counted towards these requirements.
Descrizione

MYELODYSPLASTIC SYNDROME

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3463824
availability of an 8/8 matched donor at a, b, c, and dr loci. mismatch at hla dq are permissible. matched related or unrelated donors are acceptable peripheral blood or bone marrow stem cells are acceptable
Descrizione

matched donor

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0150103
patients must be ≥ 18 years of age and considered a candidate for hct
Descrizione

age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
karnofsky ≥ 70%
Descrizione

karnofsky performance status is measure of a cancer patients general well being and activities of daily life. scores range from 100 to 0 where 100 is perfect health and 0 is death

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0206065
patients must meet acceptable organ function criteria: total bilirubin ≤2.5 mg, ast (aspartate transaminase) and alt (alanine transaminase) <5.0 x institutional upper limit of normal; gfr (glomerular filtration rate) >40 ml/min/1.73 m2 for patients with creatinine levels above institutional normal; lung function tests (dlco, fev1, fvc) > 50%; ejection fraction > 50%
Descrizione

acceptable organ function

Tipo di dati

integer

Alias
UMLS CUI [1]
C1254358
written informed consent
Descrizione

informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
women and men of child-bearing potential must agree to use adequate contraception
Descrizione

contraception

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy treatment for aml within 21 days from the initiation of hct conditioning
Descrizione

chemotherapy treatment for aml

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3665472
patients may not have evidence or symptoms of cns disease at the time of enrollment
Descrizione

CNS disorder

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007682
hiv or htlv1 / htlv2 (human t-lymphotrophic virus) (seropositivity and/or pcr positivity)
Descrizione

HIV+, htlv1

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0020094
patients less than 18 years of age
Descrizione

Less than age 18

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3261299
pregnant and nursing mothers are excluded from this study
Descrizione

pregnant

Tipo di dati

boolean

patients with untreated or uncontrolled neuropsychiatric illness
Descrizione

neuropsychiatric illness

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3203509
any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient
Descrizione

risk to the patient

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0525058
uncontrolled infections
Descrizione

Communicable Diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Acute Myeloid Leukemia NCT02328755

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
patient must have aml not in remission or at very high risk for hct (hematopoietic cell transplantation) relapse.
boolean
C0153886 (UMLS CUI [1])
induction attempts
Item
for newly diagnosed aml, patients must have achieved two consecutive induction attempts without achieving complete remission
boolean
C1514832 (UMLS CUI [1])
aml relapse
Item
for patients initially in complete remission whose aml relapses > 6 months after preceding remission, one re-induction must be attempted to be eligible
boolean
C2367456 (UMLS CUI [1])
re-induction regimen
Item
for aml patients with early relapse, in whom the preceding remission is shorter than 6 months duration, no re-induction regimen is necessary to be eligible
boolean
C0153886 (UMLS CUI [1])
MYELODYSPLASTIC SYNDROME
Item
patients with antecedent mds (myelodysplastic syndrome) who progress to aml may have therapies rendered during both phases counted towards these requirements.
boolean
C3463824 (UMLS CUI [1])
matched donor
Item
availability of an 8/8 matched donor at a, b, c, and dr loci. mismatch at hla dq are permissible. matched related or unrelated donors are acceptable peripheral blood or bone marrow stem cells are acceptable
boolean
C0150103 (UMLS CUI [1])
age
Item
patients must be ≥ 18 years of age and considered a candidate for hct
boolean
C0001779 (UMLS CUI [1])
karnofsky performance status
Item
karnofsky ≥ 70%
boolean
C0206065 (UMLS CUI [1])
Item
patients must meet acceptable organ function criteria: total bilirubin ≤2.5 mg, ast (aspartate transaminase) and alt (alanine transaminase) <5.0 x institutional upper limit of normal; gfr (glomerular filtration rate) >40 ml/min/1.73 m2 for patients with creatinine levels above institutional normal; lung function tests (dlco, fev1, fvc) > 50%; ejection fraction > 50%
integer
C1254358 (UMLS CUI [1])
acceptable organ function
Code List
patients must meet acceptable organ function criteria: total bilirubin ≤2.5 mg, ast (aspartate transaminase) and alt (alanine transaminase) <5.0 x institutional upper limit of normal; gfr (glomerular filtration rate) >40 ml/min/1.73 m2 for patients with creatinine levels above institutional normal; lung function tests (dlco, fev1, fvc) > 50%; ejection fraction > 50%
CL Item
total bilirubin ≤2.5 mg (1)
C0201913 (UMLS CUI-1)
CL Item
ast/alt 5.0 x institutional upper limit of normal (2)
C0201913 (UMLS CUI-1)
CL Item
gfr (glomerular filtration rate) >40  (3)
C0017654 (UMLS CUI-1)
CL Item
lung function tests (dlco, fev1, fvc) (4)
C0024119 (UMLS CUI-1)
informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
contraception
Item
women and men of child-bearing potential must agree to use adequate contraception
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy treatment for aml
Item
prior chemotherapy treatment for aml within 21 days from the initiation of hct conditioning
boolean
C3665472 (UMLS CUI [1])
CNS disorder
Item
patients may not have evidence or symptoms of cns disease at the time of enrollment
boolean
C0007682 (UMLS CUI [1])
HIV+, htlv1
Item
hiv or htlv1 / htlv2 (human t-lymphotrophic virus) (seropositivity and/or pcr positivity)
boolean
C0019699 (UMLS CUI [1])
C0020094 (UMLS CUI [2])
Less than age 18
Item
patients less than 18 years of age
boolean
C3261299 (UMLS CUI [1])
pregnant
Item
pregnant and nursing mothers are excluded from this study
boolean
neuropsychiatric illness
Item
patients with untreated or uncontrolled neuropsychiatric illness
boolean
C3203509 (UMLS CUI [1])
risk to the patient
Item
any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient
boolean
C0525058 (UMLS CUI [1])
Communicable Diseases
Item
uncontrolled infections
boolean
C0009450 (UMLS CUI [1])
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