ID

14127

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02328755

Stichworte

Versionen (1)
  1. 30.03.16 30.03.16 -
Hochgeladen am

30. März 2016

DOI

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Creative Commons BY 4.0
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Eligibility Acute Myeloid Leukemia NCT02328755

Englisch

Eligibility Acute Myeloid Leukemia NCT02328755

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

AML

Datentyp

boolean

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

induction attempts

Datentyp

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
Beschreibung

aml relapse

Datentyp

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
Beschreibung

re-induction regimen

Datentyp

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.
Beschreibung

MYELODYSPLASTIC SYNDROME

Datentyp

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
Beschreibung

matched donor

Datentyp

boolean

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

age

Datentyp

boolean

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

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

Datentyp

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%
Beschreibung

acceptable organ function

Datentyp

integer

Alias
UMLS CUI [1]
C1254358
written informed consent
Beschreibung

informed consent

Datentyp

boolean

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

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

chemotherapy treatment for aml

Datentyp

boolean

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

CNS disorder

Datentyp

boolean

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

HIV+, htlv1

Datentyp

boolean

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

Less than age 18

Datentyp

boolean

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

pregnant

Datentyp

boolean

patients with untreated or uncontrolled neuropsychiatric illness
Beschreibung

neuropsychiatric illness

Datentyp

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
Beschreibung

risk to the patient

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
uncontrolled infections
Beschreibung

Communicable Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
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Ähnliche Modelle

Eligibility Acute Myeloid Leukemia NCT02328755

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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