ID

30991

Descrição

Sirolimus in Combination With MEC in High Risk Myeloid Leukemias; ODM derived from: https://clinicaltrials.gov/show/NCT00780104

Link

https://clinicaltrials.gov/show/NCT00780104

Palavras-chave

Versões (1)
  1. 09/07/2018 09/07/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

9 de julho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Myeloid Leukemias NCT00780104

Inglês

Eligibility Myeloid Leukemias NCT00780104

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-m3 aml; relapsed non-m3 aml; secondary aml; intermediate or poor prognosis de novo aml in patients who are >= 60 years old
Descrição

Myeloid Leukemia Advanced | Refractory Acute Myeloid Leukemia Primary FAB | Recurrent adult acute myeloid leukemia FAB | Secondary acute myeloid leukemia | AML de novo Prognosis Intermediate | AML de novo Prognosis bad | Age

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023470
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C4528668
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C2984084
UMLS CUI [3,1]
C0278780
UMLS CUI [3,2]
C2984084
UMLS CUI [4]
C0280449
UMLS CUI [5,1]
C0023467
UMLS CUI [5,2]
C1515568
UMLS CUI [5,3]
C0033325
UMLS CUI [5,4]
C0205103
UMLS CUI [6,1]
C0023467
UMLS CUI [6,2]
C1515568
UMLS CUI [6,3]
C0278252
UMLS CUI [7]
C0001779
>= 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0, 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
able to consume oral medication
Descrição

Able to swallow Oral medication

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
initial laboratory values: creatinine <= 2.0 mg/dl; total or direct bilirubin <= 1.5/dl; sgpt(alt) <= 3xuln; negative pregnancy test for women with child-bearing potential
Descrição

Laboratory Results Initial | Creatinine measurement, serum | Serum total bilirubin measurement | Bilirubin, direct measurement | Alanine aminotransferase measurement | Childbearing Potential Pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205265
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201916
UMLS CUI [5]
C0201836
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0427780
ejection fraction of >= 45%
Descrição

Cardiac ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232174
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with fam b3
Descrição

Other Coding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3846158
must not be receiving chemotherapy (except hydroxyurea)
Descrição

Chemotherapy | Exception Hydroxyurea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020402
not receiving growth factors, except for erythropoietin
Descrição

Growth Factor | Exception Erythropoietin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018284
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0014822
subjects with a "currently active" second malignancy other than non-melanoma skin cancers
Descrição

Second Cancer | Exception Skin carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, mi within the last 6 months or uncontrolled cardiac arrhythmia
Descrição

Uncontrolled hypertension | Angina, Unstable | Symptomatic congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0205318
subjects taking diltiazem
Descrição

Diltiazem

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0012373
subjects who require hiv protease inhibitors or those with aids-related illnesses
Descrição

Patient need for HIV Protease Inhibitors | AIDS related illness

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0162714
UMLS CUI [2]
C0740842
no evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
Descrição

Cerebellar Dysfunction | Cerebellar Dysfunction During Cytarabine Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007760
UMLS CUI [2,1]
C0007760
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0010711
UMLS CUI [2,4]
C0087111
not pregnant or breastfeeding
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
uncontrolled infection
Descrição

Communicable Disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
subjects taking carbamazepine, rifabutin, rifampin, rifapentine, st. john's wort, clarithromycin, cyclosporine, diltiazem, erythromycin, telithromycin, verapamil, tacrolimus
Descrição

Carbamazepine | Rifabutin | Rifampin | rifapentine | ST. JOHN'S WORT EXTRACT | Clarithromycin | Cyclosporine | Diltiazem | Erythromycin | telithromycin | Verapamil | Tacrolimus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006949
UMLS CUI [2]
C0140575
UMLS CUI [3]
C0035608
UMLS CUI [4]
C0073372
UMLS CUI [5]
C0813171
UMLS CUI [6]
C0055856
UMLS CUI [7]
C0010592
UMLS CUI [8]
C0012373
UMLS CUI [9]
C0014806
UMLS CUI [10]
C0907410
UMLS CUI [11]
C0042523
UMLS CUI [12]
C0085149
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Similar models

Eligibility Myeloid Leukemias NCT00780104

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Myeloid Leukemia Advanced | Refractory Acute Myeloid Leukemia Primary FAB | Recurrent adult acute myeloid leukemia FAB | Secondary acute myeloid leukemia | AML de novo Prognosis Intermediate | AML de novo Prognosis bad | Age
Item
must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-m3 aml; relapsed non-m3 aml; secondary aml; intermediate or poor prognosis de novo aml in patients who are >= 60 years old
boolean
C0023470 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C4528668 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C2984084 (UMLS CUI [2,3])
C0278780 (UMLS CUI [3,1])
C2984084 (UMLS CUI [3,2])
C0280449 (UMLS CUI [4])
C0023467 (UMLS CUI [5,1])
C1515568 (UMLS CUI [5,2])
C0033325 (UMLS CUI [5,3])
C0205103 (UMLS CUI [5,4])
C0023467 (UMLS CUI [6,1])
C1515568 (UMLS CUI [6,2])
C0278252 (UMLS CUI [6,3])
C0001779 (UMLS CUI [7])
Age
Item
>= 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0, 1
boolean
C1520224 (UMLS CUI [1])
Able to swallow Oral medication
Item
able to consume oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Laboratory Results Initial | Creatinine measurement, serum | Serum total bilirubin measurement | Bilirubin, direct measurement | Alanine aminotransferase measurement | Childbearing Potential Pregnancy test negative
Item
initial laboratory values: creatinine <= 2.0 mg/dl; total or direct bilirubin <= 1.5/dl; sgpt(alt) <= 3xuln; negative pregnancy test for women with child-bearing potential
boolean
C1254595 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201916 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0427780 (UMLS CUI [6,2])
Cardiac ejection fraction
Item
ejection fraction of >= 45%
boolean
C0232174 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Other Coding
Item
subjects with fam b3
boolean
C3846158 (UMLS CUI [1])
Chemotherapy | Exception Hydroxyurea
Item
must not be receiving chemotherapy (except hydroxyurea)
boolean
C0392920 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020402 (UMLS CUI [2,2])
Growth Factor | Exception Erythropoietin
Item
not receiving growth factors, except for erythropoietin
boolean
C0018284 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0014822 (UMLS CUI [2,2])
Second Cancer | Exception Skin carcinoma
Item
subjects with a "currently active" second malignancy other than non-melanoma skin cancers
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Uncontrolled hypertension | Angina, Unstable | Symptomatic congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled
Item
subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, mi within the last 6 months or uncontrolled cardiac arrhythmia
boolean
C1868885 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Diltiazem
Item
subjects taking diltiazem
boolean
C0012373 (UMLS CUI [1])
Patient need for HIV Protease Inhibitors | AIDS related illness
Item
subjects who require hiv protease inhibitors or those with aids-related illnesses
boolean
C0686904 (UMLS CUI [1,1])
C0162714 (UMLS CUI [1,2])
C0740842 (UMLS CUI [2])
Cerebellar Dysfunction | Cerebellar Dysfunction During Cytarabine Therapy
Item
no evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
boolean
C0007760 (UMLS CUI [1])
C0007760 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0010711 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
not pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Disease Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Carbamazepine | Rifabutin | Rifampin | rifapentine | ST. JOHN'S WORT EXTRACT | Clarithromycin | Cyclosporine | Diltiazem | Erythromycin | telithromycin | Verapamil | Tacrolimus
Item
subjects taking carbamazepine, rifabutin, rifampin, rifapentine, st. john's wort, clarithromycin, cyclosporine, diltiazem, erythromycin, telithromycin, verapamil, tacrolimus
boolean
C0006949 (UMLS CUI [1])
C0140575 (UMLS CUI [2])
C0035608 (UMLS CUI [3])
C0073372 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
C0055856 (UMLS CUI [6])
C0010592 (UMLS CUI [7])
C0012373 (UMLS CUI [8])
C0014806 (UMLS CUI [9])
C0907410 (UMLS CUI [10])
C0042523 (UMLS CUI [11])
C0085149 (UMLS CUI [12])
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