ID

13158

Beskrivning

Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes; ODM derived from: https://clinicaltrials.gov/show/NCT00038870

Länk

https://clinicaltrials.gov/show/NCT00038870

Nyckelord

  1. 2016-01-20 2016-01-20 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

20 januari 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Acute Myelogenous Leukemia NCT00038870

Eligibility Acute Myelogenous Leukemia NCT00038870

Criteria
Beskrivning

Criteria

aml patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) wbc > 50,000, or c) age > 60 years*.
Beskrivning

AML patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) wbc > 50,000, or c) age > 60 years*

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
aml patients are eligible for cell collection if they have > 1000 circulating blasts/mm at diagnosis.
Beskrivning

> 1000 circulating blasts/mm at diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0523113
cml patients in myeloid blast crisis with > 1000 circulating blasts/mm.
Beskrivning

CML in myeloid blast crisis

Datatyp

boolean

Alias
UMLS CUI [1]
C0023474
creatinine <2, bilirubin <3.
Beskrivning

creatinine, bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
age >18.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
Beskrivning

factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure

Datatyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
concurrent or expected need for therapy with corticosteroids.
Beskrivning

need for corticosteroids

Datatyp

text

Alias
UMLS CUI [1]
C0001617
positive antibody to human immunodeficiency virus i.
Beskrivning

HIV

Datatyp

text

Alias
UMLS CUI [1]
C0019682
acute promyelocytic leukemia (fab-m3).
Beskrivning

APL

Datatyp

text

Alias
UMLS CUI [1]
C0023487
history of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy.
Beskrivning

comorbidity

Datatyp

text

Alias
UMLS CUI [1]
C0009488
patients >60 will be eligible for study but if found to have good prognosis cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from study and treated off protocol without infusion of autologous leukemia derived cells.
Beskrivning

inversion 16 or t(8;21)

Datatyp

text

Alias
UMLS CUI [1]
C4014436
UMLS CUI [2]
C3897139

Similar models

Eligibility Acute Myelogenous Leukemia NCT00038870

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
AML patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) wbc > 50,000, or c) age > 60 years*
Item
aml patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) wbc > 50,000, or c) age > 60 years*.
boolean
C0023467 (UMLS CUI [1])
> 1000 circulating blasts/mm at diagnosis
Item
aml patients are eligible for cell collection if they have > 1000 circulating blasts/mm at diagnosis.
boolean
C0523113 (UMLS CUI [1])
CML in myeloid blast crisis
Item
cml patients in myeloid blast crisis with > 1000 circulating blasts/mm.
boolean
C0023474 (UMLS CUI [1])
creatinine, bilirubin
Item
creatinine <2, bilirubin <3.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
age
Item
age >18.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI-1)
factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure
Item
factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
text
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
need for corticosteroids
Item
concurrent or expected need for therapy with corticosteroids.
text
C0001617 (UMLS CUI [1])
HIV
Item
positive antibody to human immunodeficiency virus i.
text
C0019682 (UMLS CUI [1])
APL
Item
acute promyelocytic leukemia (fab-m3).
text
C0023487 (UMLS CUI [1])
comorbidity
Item
history of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy.
text
C0009488 (UMLS CUI [1])
inversion 16 or t(8;21)
Item
patients >60 will be eligible for study but if found to have good prognosis cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from study and treated off protocol without infusion of autologous leukemia derived cells.
text
C4014436 (UMLS CUI [1])
C3897139 (UMLS CUI [2])

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