ID

13744

Description

A Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01034410

Link

https://clinicaltrials.gov/show/NCT01034410

Keywords

Versions (1)
  1. 3/2/16 3/2/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 2, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01034410

English

Eligibility Acute Myeloid Leukemia NCT01034410

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of aml as defined by the world health organization (who) classification (vardiman 2009)
Description

diagnosis of aml as defined by the world health organization (who) classification (vardiman 2009)

Data type

boolean

Alias
UMLS CUI [1]
C0023467
primary refractory aml (defined as a failure to achieve a cr or cri after therapy with curative intent) or aml in first relapse
Description

primary refractory aml (defined as a failure to achieve a cr or cri after therapy with curative intent) or aml in first relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
ecog performance status 0, 1 or 2
Description

ecog performance status 0, 1 or 2

Data type

boolean

Alias
UMLS CUI [1]
C1520224
age > 18 and < 70 years
Description

age > 18 and < 70 years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
for patients presenting with primary refractory aml, > 20% blasts on baseline bone marrow assessment
Description

for patients presenting with primary refractory aml, > 20% blasts on baseline bone marrow assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C1982687
for patients presenting with relapsed aml, > 5% blasts on baseline bone marrow assessment
Description

for patients presenting with relapsed aml, > 5% blasts on baseline bone marrow assessment

Data type

boolean

Alias
UMLS CUI [1]
C1982687
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0277556
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an initial diagnosis of acute promyelocytic leukemia (as defined by french-american-british criteria (bennett 1976))
Description

an initial diagnosis of acute promyelocytic leukemia (as defined by french-american-british criteria (bennett 1976))

Data type

boolean

Alias
UMLS CUI [1]
C0023487
secondary aml, defined as aml evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
Description

secondary aml, defined as aml evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent

Data type

boolean

Alias
UMLS CUI [1]
C0280449
clinically active cns leukemia
Description

clinically active cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
Description

previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0010711
UMLS CUI [1,2]
C2986497
previously received > 1 induction regimen (defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)
Description

previously received > 1 induction regimen (defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)

Data type

boolean

Alias
UMLS CUI [1]
C3179010
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Similar models

Eligibility Acute Myeloid Leukemia NCT01034410

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
diagnosis of aml as defined by the world health organization (who) classification (vardiman 2009)
boolean
C0023467 (UMLS CUI [1])
AML refractory
Item
primary refractory aml (defined as a failure to achieve a cr or cri after therapy with curative intent) or aml in first relapse
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
ECOG
Item
ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
age
Item
age > 18 and < 70 years
boolean
C0001779 (UMLS CUI [1])
blasts on baseline bone marrow
Item
for patients presenting with primary refractory aml, > 20% blasts on baseline bone marrow assessment
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C1982687 (UMLS CUI [2])
relapsed aml
Item
for patients presenting with relapsed aml, > 5% blasts on baseline bone marrow assessment
boolean
C1982687 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
acute promyelocytic leukemia
Item
an initial diagnosis of acute promyelocytic leukemia (as defined by french-american-british criteria (bennett 1976))
boolean
C0023487 (UMLS CUI [1])
secondary aml
Item
secondary aml, defined as aml evolving from antecedent hematological disorder or prior exposure to leukemogenic therapy or agent
boolean
C0280449 (UMLS CUI [1])
cns leukemia
Item
clinically active cns leukemia
boolean
C1332884 (UMLS CUI [1])
cumulative dose cytarabine
Item
previously received a total cumulative dose of cytarabine > 6g/m2 in the last 6 months
boolean
C0010711 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
induction regimen
Item
previously received > 1 induction regimen (defined as 1 or 2 cycles of a drug or a drug combination administered as remission induction therapy)
boolean
C3179010 (UMLS CUI [1])
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