ID

13238

Description

A Phase I Study of IGN523 in Subjects With Relapsed or Refractory AML; ODM derived from: https://clinicaltrials.gov/show/NCT02040506

Link

https://clinicaltrials.gov/show/NCT02040506

Keywords

  1. 1/25/16 1/25/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 25, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Acute Myelogenous Leukemia NCT02040506

Eligibility Acute Myelogenous Leukemia NCT02040506

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed or treatment-refractory aml
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
eastern cooperative oncology group status 0-2
Description

ECOG

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 weeks
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate baseline renal and hepatic function
Description

renal and hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
measurable disease (eg, peripheral blasts greater than 5%)
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic myelogenous leukemia in blast crisis
Description

CML

Data type

boolean

Alias
UMLS CUI [1]
C0023474
monoclonal therapy within 4 weeks, or chemotherapy or radiotherapy within 2 weeks
Description

monoclonal therapy or chemotherapy or radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279694
unresolved acute toxicity from prior anti-cancer therapy
Description

toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0013221
prior allogeneic stem cell transplant and active graft-versus-host disease requiring systemic immunosuppressive therapy within 15 days prior to screening
Description

stem cell transplant and graft-versus-host disease

Data type

boolean

Alias
UMLS CUI [1]
C1504389
UMLS CUI [2]
C0018133
history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
Description

allergic or anaphylactic reactions to monoclonal antibody therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0279694
known current leptomeningeal or central nervous system (cns) involvement of leukemia
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884

Similar models

Eligibility Acute Myelogenous Leukemia NCT02040506

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
relapsed or treatment-refractory aml
boolean
C0023467 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group status 0-2
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
renal and hepatic function
Item
adequate baseline renal and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
measurable disease
Item
measurable disease (eg, peripheral blasts greater than 5%)
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CML
Item
chronic myelogenous leukemia in blast crisis
boolean
C0023474 (UMLS CUI [1])
monoclonal therapy or chemotherapy or radiotherapy
Item
monoclonal therapy within 4 weeks, or chemotherapy or radiotherapy within 2 weeks
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279694 (UMLS CUI [3])
toxicity
Item
unresolved acute toxicity from prior anti-cancer therapy
boolean
C0013221 (UMLS CUI [1])
stem cell transplant and graft-versus-host disease
Item
prior allogeneic stem cell transplant and active graft-versus-host disease requiring systemic immunosuppressive therapy within 15 days prior to screening
boolean
C1504389 (UMLS CUI [1])
C0018133 (UMLS CUI [2])
allergic or anaphylactic reactions to monoclonal antibody therapy
Item
history of severe allergic or anaphylactic reactions to monoclonal antibody therapy
boolean
C0020517 (UMLS CUI [1,1])
C0279694 (UMLS CUI [1,2])
cns leukemia
Item
known current leptomeningeal or central nervous system (cns) involvement of leukemia
boolean
C1332884 (UMLS CUI [1])

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