ID

14566

Description

Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01835288

Lien

https://clinicaltrials.gov/show/NCT01835288

Mots-clés

  1. 21/04/2016 21/04/2016 -
Téléchargé le

21 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aml, any french- american- british (fab) subtype except m3, with confirmed mutation in the npm1 gene
Description

aml

Type de données

boolean

Alias
UMLS CUI [1]
C0023467
relapsed and/or refractory aml from any duration of complete remission (cr); any number of prior therapies allowed
Description

relapsed and/or refractory aml

Type de données

boolean

Alias
UMLS CUI [1]
C2367456
eastern cooperative oncology group (ecog) performance status 0-2, life expectancy > 3 months
Description

eastern cooperative oncology group (ecog) performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
serum creatinine =< 2.0 mg/dl
Description

serum creatinine

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin =< 2.0 mg/dl
Description

bilirubin

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
alanine aminotransferase (alt)/aspartate aminotransferase (ast) =< 3 x upper limit of normal (uln)
Description

alanine aminotransferase

Type de données

boolean

Alias
UMLS CUI [1]
C0201836
ability to understand and the willingness to sign a written informed consent document
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
Description

pregnant or breast-feeding

Type de données

boolean

Alias
UMLS CUI [1]
C3242212
patients who are currently receiving another investigational drug
Description

investigational drug

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
patients who are currently receiving other anti-cancer agents
Description

anti-cancer agents

Type de données

boolean

Alias
UMLS CUI [1]
C0003392
uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Description

infection

Type de données

boolean

Alias
UMLS CUI [1]
C3714514
known hypersensitivity to arsenic trioxide
Description

hypersensitivity to arsenic trioxide

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0052416

Similar models

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
aml
Item
aml, any french- american- british (fab) subtype except m3, with confirmed mutation in the npm1 gene
boolean
C0023467 (UMLS CUI [1])
relapsed and/or refractory aml
Item
relapsed and/or refractory aml from any duration of complete remission (cr); any number of prior therapies allowed
boolean
C2367456 (UMLS CUI [1])
eastern cooperative oncology group (ecog) performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2, life expectancy > 3 months
boolean
C1520224 (UMLS CUI [1])
serum creatinine
Item
serum creatinine =< 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
bilirubin =< 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
alanine aminotransferase
Item
alanine aminotransferase (alt)/aspartate aminotransferase (ast) =< 3 x upper limit of normal (uln)
boolean
C0201836 (UMLS CUI [1])
informed consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or breast-feeding
Item
pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
boolean
C3242212 (UMLS CUI [1])
investigational drug
Item
patients who are currently receiving another investigational drug
boolean
C0013230 (UMLS CUI [1])
anti-cancer agents
Item
patients who are currently receiving other anti-cancer agents
boolean
C0003392 (UMLS CUI [1])
infection
Item
uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
boolean
C3714514 (UMLS CUI [1])
hypersensitivity to arsenic trioxide
Item
known hypersensitivity to arsenic trioxide
boolean
C0020517 (UMLS CUI [1,1])
C0052416 (UMLS CUI [1,2])

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