ID

13158

Description

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

Link

https://clinicaltrials.gov/show/NCT00038870

Keywords

Versions (1)
  1. 1/20/16 1/20/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 20, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00038870

English

Eligibility Acute Myelogenous Leukemia NCT00038870

1 forms  
Criteria
Description

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*.
Description

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*

Data type

boolean

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

> 1000 circulating blasts/mm at diagnosis

Data type

boolean

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

CML in myeloid blast crisis

Data type

boolean

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

creatinine, bilirubin

Data type

boolean

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

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

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.
Description

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

Data type

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.
Description

need for corticosteroids

Data type

text

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

HIV

Data type

text

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

APL

Data type

text

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

comorbidity

Data type

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.
Description

inversion 16 or t(8;21)

Data type

text

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

Eligibility Acute Myelogenous Leukemia NCT00038870

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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