ID

24577

Beskrivning

Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00510887

Länk

https://clinicaltrials.gov/show/NCT00510887

Nyckelord

Versioner (1)
  1. 2017-08-07 2017-08-07 -
Uppladdad den

7 augusti 2017

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT00510887

Engelsk

Eligibility Lymphoma, Follicular NCT00510887

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
Beskrivning

Follicular Lymphoma Ann Arbor lymphoma staging system | Therapeutic procedure Quantity | Persistent Disease | Recurrent disease | Refractory Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C2983415
UMLS CUI [4]
C0277556
UMLS CUI [5]
C1514815
no prior bortezomib therapy.
Beskrivning

Bortezomib Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1176309
UMLS CUI [1,2]
C0332197
voluntary written informed consent.
Beskrivning

Informed Consent

Datatyp

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.
Beskrivning

Postmenopausal state | Female Sterilization | Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
Beskrivning

Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
18 years of age or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
aspartate aminotransferase (ast),alanine aminotransferase (alt), total bilirubin < 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exclusion Measurement Secondary to Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4,1]
C2828389
UMLS CUI [4,2]
C0242485
UMLS CUI [4,3]
C0175668
UMLS CUI [4,4]
C0024299
eastern cooperative oncology group (ecog) performance status 0-2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
platelet count of < 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
Beskrivning

Platelet Count measurement | Exclusion Platelet count Due to Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C1287267
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0012634
absolute neutrophil count of < 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
Beskrivning

Absolute neutrophil count | Exclusion ANC Due to Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0948762
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0012634
estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0373595
≥grade 2 peripheral neuropathy within 14 days before enrollment.
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
myocardial infarction within 6 months prior to enrollment or has new york hospital association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
Beskrivning

Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Uncontrolled Severe | Ischemia Electrocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C0205082
UMLS CUI [5,1]
C0022116
UMLS CUI [5,2]
C1623258
patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
Beskrivning

Hypersensitivity Boron | Mannitol allergy | Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006030
UMLS CUI [2]
C0571922
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
female subject is pregnant or lactating.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
received other investigational drugs for this disease within 14 days of enrollment
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Beskrivning

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

Datatyp

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
known hiv+ status.
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
cardiac ejection fraction less than 35% at study entry measured by echocardiogram, multigated acquisition (muga) or cardiac mri.
Beskrivning

Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Multiple gated acquisition scanning | Cardiac ejection fraction MRI of Heart

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0521317
UMLS CUI [3,1]
C0232174
UMLS CUI [3,2]
C0412692
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Similar models

Eligibility Lymphoma, Follicular NCT00510887

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma Ann Arbor lymphoma staging system | Therapeutic procedure Quantity | Persistent Disease | Recurrent disease | Refractory Disease
Item
diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2983415 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C1514815 (UMLS CUI [5])
Bortezomib Absent
Item
no prior bortezomib therapy.
boolean
C1176309 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
voluntary written informed consent.
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods
Item
female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Gender Contraceptive methods
Item
male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Age
Item
18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exclusion Measurement Secondary to Lymphoma
Item
aspartate aminotransferase (ast),alanine aminotransferase (alt), total bilirubin < 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C2828389 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C0175668 (UMLS CUI [4,3])
C0024299 (UMLS CUI [4,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Platelet Count measurement | Exclusion Platelet count Due to Disease
Item
platelet count of < 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
boolean
C0032181 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C1287267 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0012634 (UMLS CUI [2,4])
Absolute neutrophil count | Exclusion ANC Due to Disease
Item
absolute neutrophil count of < 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
boolean
C0948762 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0948762 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0012634 (UMLS CUI [2,4])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
≥grade 2 peripheral neuropathy within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Uncontrolled Severe | Ischemia Electrocardiography
Item
myocardial infarction within 6 months prior to enrollment or has new york hospital association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
Hypersensitivity Boron | Mannitol allergy | Hypersensitivity Investigational New Drugs
Item
patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
boolean
C0020517 (UMLS CUI [1,1])
C0006030 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
female subject is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
received other investigational drugs for this disease within 14 days of enrollment
boolean
C0013230 (UMLS CUI [1])
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])
HIV Seropositivity
Item
known hiv+ status.
boolean
C0019699 (UMLS CUI [1])
Cardiac ejection fraction Echocardiography | Cardiac ejection fraction Multiple gated acquisition scanning | Cardiac ejection fraction MRI of Heart
Item
cardiac ejection fraction less than 35% at study entry measured by echocardiogram, multigated acquisition (muga) or cardiac mri.
boolean
C0232174 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0232174 (UMLS CUI [3,1])
C0412692 (UMLS CUI [3,2])
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