ID

30429

Descripción

EL625 in Persistent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00636155

Link

https://clinicaltrials.gov/show/NCT00636155

Palabras clave

Versiones (1)
  1. 5/6/18 5/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, Small Lymphocytic NCT00636155

Inglés

Eligibility Lymphoma, Small Lymphocytic NCT00636155

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of cll/sll who have received at least one prior treatment regimen and have persistent disease (i.e. any evidence of active disease). patients with a chromosome 17 abnormality or a p53 mutation of any type may be enrolled without having received prior treatment.
Descripción

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Prior Therapy Quantity | Persistent Disease | Chromosome 17 Abnormality | p53 Mutation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1302547
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C2983415
UMLS CUI [4]
C4329664
UMLS CUI [5]
C3897380
patients must be 18 years of age or older.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patient has an estimated or measured creatinine clearance ≥30 ml/min at study enrollment.
Descripción

Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0373595
ast, alt, total bilirubin < than 2.5 times the upper limit of normal.
Descripción

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
wbc > 1.5; anc >500; plt >50,000 unless documented as due to disease
Descripción

White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Exception Relationship Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C0012634
ecog performance status of 0-2.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for 2 weeks after administration of the study drug.
Descripción

Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0221829
UMLS CUI [9]
C0036899
male subject agrees to use an acceptable method for contraception for the duration of the study therapy and for 2 weeks after administration of study drug.
Descripción

Gender Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant or lactating.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Descripción

Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3841614
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer, resected early stage prostate cancer not requiring systemic treatment or cis of the cervix or fully treated early stage prostate cancer.
Descripción

Cancer Other | Remission Documented | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Prostate carcinoma Early stage Resected | Requirement Systemic therapy Absent | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma Early stage Treated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0687702
UMLS CUI [2,2]
C1301725
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C2363430
UMLS CUI [5,4]
C1521996
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C1515119
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0851140
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0600139
UMLS CUI [8,3]
C2363430
UMLS CUI [8,4]
C1522326
significant cardiac or vascular events within 6 months: acute mi, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (nyha class ≥ 2), uncontrolled cardiac arrhythmias, and disseminated intravascular coagulation.
Descripción

Cardiac event | Event Vascular | Myocardial Infarction | Angina, Unstable | Peripheral Vascular Disease Severe | Ischemic pain At rest Class | Non-healing ulcer of skin | Wound, non-healing | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled | Disseminated Intravascular Coagulation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0741923
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C1801960
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0085096
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0745417
UMLS CUI [6,2]
C0443144
UMLS CUI [6,3]
C0456387
UMLS CUI [7]
C0748826
UMLS CUI [8]
C0750433
UMLS CUI [9,1]
C0018802
UMLS CUI [9,2]
C1275491
UMLS CUI [10,1]
C0003811
UMLS CUI [10,2]
C0205318
UMLS CUI [11]
C0012739
patients who are unable to refrain from taking acetaminophen
Descripción

Acetaminophen Avoidance Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C1299582
investigational agent within 14 days of enrolling on the study.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
patients unable or unwilling to refrain from antioxidants including vitamin a, vitamin c, vitamin e, lycopene, lutein, grape seed extract, pycnogenol, green tea extract, and the like.
Descripción

Antioxidants Avoidance Unable | Antioxidants Avoidance Unwilling | Vitamin A | Ascorbic Acid | Vitamin E | lycopene | Lutein | Grape Seed Extract | Pycnogenol | Green Tea Extract

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003402
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0003402
UMLS CUI [2,2]
C0870186
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0042839
UMLS CUI [4]
C0003968
UMLS CUI [5]
C0042874
UMLS CUI [6]
C0065331
UMLS CUI [7]
C0043328
UMLS CUI [8]
C0772454
UMLS CUI [9]
C0072642
UMLS CUI [10]
C1704263
patients who have received a prior allogenic stem cell transplant and have at least 2.5% donor cells still evident on engraftment studies.
Descripción

Allogeneic hematopoietic stem cell transplant | Donor Cells Percentage Engraftment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4255274
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0038250
UMLS CUI [2,3]
C0439165
UMLS CUI [2,4]
C0301944
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Similar models

Eligibility Lymphoma, Small Lymphocytic NCT00636155

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Prior Therapy Quantity | Persistent Disease | Chromosome 17 Abnormality | p53 Mutation
Item
patients with a diagnosis of cll/sll who have received at least one prior treatment regimen and have persistent disease (i.e. any evidence of active disease). patients with a chromosome 17 abnormality or a p53 mutation of any type may be enrolled without having received prior treatment.
boolean
C1302547 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2983415 (UMLS CUI [3])
C4329664 (UMLS CUI [4])
C3897380 (UMLS CUI [5])
Age
Item
patients must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
patient has an estimated or measured creatinine clearance ≥30 ml/min at study enrollment.
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
ast, alt, total bilirubin < than 2.5 times the upper limit of normal.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Exception Relationship Disease
Item
wbc > 1.5; anc >500; plt >50,000 unless documented as due to disease
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C0012634 (UMLS CUI [4,3])
ECOG performance status
Item
ecog performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence
Item
female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for 2 weeks after administration of the study drug.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
Gender Contraceptive methods
Item
male subject agrees to use an acceptable method for contraception for the duration of the study therapy and for 2 weeks after administration of study drug.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
female who is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Serious Interferes with Study Subject Participation Status | Serious mental illness Interferes with Study Subject Participation Status
Item
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3841614 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Cancer Other | Remission Documented | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Prostate carcinoma Early stage Resected | Requirement Systemic therapy Absent | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma Early stage Treated
Item
patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer, resected early stage prostate cancer not requiring systemic treatment or cis of the cervix or fully treated early stage prostate cancer.
boolean
C1707251 (UMLS CUI [1])
C0687702 (UMLS CUI [2,1])
C1301725 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C2363430 (UMLS CUI [5,3])
C1521996 (UMLS CUI [5,4])
C1514873 (UMLS CUI [6,1])
C1515119 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0851140 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0600139 (UMLS CUI [8,2])
C2363430 (UMLS CUI [8,3])
C1522326 (UMLS CUI [8,4])
Cardiac event | Event Vascular | Myocardial Infarction | Angina, Unstable | Peripheral Vascular Disease Severe | Ischemic pain At rest Class | Non-healing ulcer of skin | Wound, non-healing | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled | Disseminated Intravascular Coagulation
Item
significant cardiac or vascular events within 6 months: acute mi, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (nyha class ≥ 2), uncontrolled cardiac arrhythmias, and disseminated intravascular coagulation.
boolean
C0741923 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C1801960 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0085096 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0745417 (UMLS CUI [6,1])
C0443144 (UMLS CUI [6,2])
C0456387 (UMLS CUI [6,3])
C0748826 (UMLS CUI [7])
C0750433 (UMLS CUI [8])
C0018802 (UMLS CUI [9,1])
C1275491 (UMLS CUI [9,2])
C0003811 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C0012739 (UMLS CUI [11])
Acetaminophen Avoidance Unable
Item
patients who are unable to refrain from taking acetaminophen
boolean
C0000970 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Investigational New Drugs
Item
investigational agent within 14 days of enrolling on the study.
boolean
C0013230 (UMLS CUI [1])
Antioxidants Avoidance Unable | Antioxidants Avoidance Unwilling | Vitamin A | Ascorbic Acid | Vitamin E | lycopene | Lutein | Grape Seed Extract | Pycnogenol | Green Tea Extract
Item
patients unable or unwilling to refrain from antioxidants including vitamin a, vitamin c, vitamin e, lycopene, lutein, grape seed extract, pycnogenol, green tea extract, and the like.
boolean
C0003402 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0003402 (UMLS CUI [2,1])
C0870186 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0042839 (UMLS CUI [3])
C0003968 (UMLS CUI [4])
C0042874 (UMLS CUI [5])
C0065331 (UMLS CUI [6])
C0043328 (UMLS CUI [7])
C0772454 (UMLS CUI [8])
C0072642 (UMLS CUI [9])
C1704263 (UMLS CUI [10])
Allogeneic hematopoietic stem cell transplant | Donor Cells Percentage Engraftment
Item
patients who have received a prior allogenic stem cell transplant and have at least 2.5% donor cells still evident on engraftment studies.
boolean
C4255274 (UMLS CUI [1])
C0013018 (UMLS CUI [2,1])
C0038250 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0301944 (UMLS CUI [2,4])
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