ID

14568

Descripción

Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02144675

Link

https://clinicaltrials.gov/show/NCT02144675

Palabras clave

Versiones (1)
  1. 21/4/16 21/4/16 -
Subido en

21 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT02144675

Inglés

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT02144675

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a diagnosis of non-m3 aml (patients with m3 subtype are excluded); determination of the presence of cytogenetic abnormalities will be by standard cytogenetics +/- fluorescent-in-situ (fish) studies; additional molecular analyses for nucleophosmin (npm) mutation and fms-related tyrosine kinase 3 (flt3) internal tandem duplication will be obtained as a part of standard care by institutional procedures
Descripción

aml

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
leukemic blast count > 1500/mm^3 of peripheral blood
Descripción

leukemic blast count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2697913
patients must have an eastern cooperative oncology group (ecog) performance status =< 3
Descripción

eastern cooperative oncology group (ecog) performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
total bilirubin < 2 times the institutional upper limit of normal (uln)
Descripción

total bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201913
aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase [sgot]) < 3 times the institutional uln
Descripción

aspartate aminotransferase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
serum creatinine < 1.5 times the institutional uln
Descripción

serum creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
multi gated acquisition scan (muga) or echocardiogram with left ventricular ejection fraction (lvef) > 50%
Descripción

Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428772
women of childbearing potential must have a negative pregnancy test
Descripción

negative pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
no uncontrolled psychiatric illness that the principal investigator feels will compromise obtaining informed consent from a patient
Descripción

psychiatric illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
patient must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines; patients who do not provide informed consent will not be eligible for the study
Descripción

informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any coexisting medical condition or medications precluding full compliance with any of the arms of the study
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0009488
allergies to any investigational drugs and/or to the chemotherapeutic agents
Descripción

allergies to any investigational drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0729502
allergies to any non-steroidal anti-inflammatory drugs (nsaids)/salicylates (e.g., aspirin)
Descripción

allergies to any non-steroidal anti-inflammatory drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003211
endoscopically documented upper or lower gastrointestinal (gi) related hemorrhage within last 6 months; also, patients with a clinical diagnosis of gi bleeding requiring blood transfusions will be excluded
Descripción

gastrointestinal hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017181
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Similar models

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT02144675

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
aml
Item
patients must have a diagnosis of non-m3 aml (patients with m3 subtype are excluded); determination of the presence of cytogenetic abnormalities will be by standard cytogenetics +/- fluorescent-in-situ (fish) studies; additional molecular analyses for nucleophosmin (npm) mutation and fms-related tyrosine kinase 3 (flt3) internal tandem duplication will be obtained as a part of standard care by institutional procedures
boolean
C0023467 (UMLS CUI [1])
leukemic blast count
Item
leukemic blast count > 1500/mm^3 of peripheral blood
boolean
C2697913 (UMLS CUI [1])
eastern cooperative oncology group (ecog) performance status
Item
patients must have an eastern cooperative oncology group (ecog) performance status =< 3
boolean
C1520224 (UMLS CUI [1])
total bilirubin
Item
total bilirubin < 2 times the institutional upper limit of normal (uln)
boolean
C0201913 (UMLS CUI [1])
aspartate aminotransferase
Item
aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase [sgot]) < 3 times the institutional uln
boolean
C0201899 (UMLS CUI [1])
serum creatinine
Item
serum creatinine < 1.5 times the institutional uln
boolean
C0201976 (UMLS CUI [1])
Left ventricular ejection fraction
Item
multi gated acquisition scan (muga) or echocardiogram with left ventricular ejection fraction (lvef) > 50%
boolean
C0428772 (UMLS CUI [1])
negative pregnancy test
Item
women of childbearing potential must have a negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
psychiatric illness
Item
no uncontrolled psychiatric illness that the principal investigator feels will compromise obtaining informed consent from a patient
boolean
C0004936 (UMLS CUI [1])
informed consent
Item
patient must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines; patients who do not provide informed consent will not be eligible for the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Protocol Compliance
Item
any coexisting medical condition or medications precluding full compliance with any of the arms of the study
boolean
C0525058 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
allergies to any investigational drugs
Item
allergies to any investigational drugs and/or to the chemotherapeutic agents
boolean
C0020517 (UMLS CUI [1,1])
C0729502 (UMLS CUI [1,2])
allergies to any non-steroidal anti-inflammatory drugs
Item
allergies to any non-steroidal anti-inflammatory drugs (nsaids)/salicylates (e.g., aspirin)
boolean
C0020517 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
gastrointestinal hemorrhage
Item
endoscopically documented upper or lower gastrointestinal (gi) related hemorrhage within last 6 months; also, patients with a clinical diagnosis of gi bleeding requiring blood transfusions will be excluded
boolean
C0017181 (UMLS CUI [1])
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