ID

26002

Beskrivning

Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00434629

Länk

https://clinicaltrials.gov/show/NCT00434629

Nyckelord

Versioner (2)
  1. 2017-10-02 2017-10-02 -
  2. 2017-10-04 2017-10-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 oktober 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility B-Cell Lymphoma NCT00434629

Engelsk

Eligibility B-Cell Lymphoma NCT00434629

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693 (Inclusion)
cd20 positive b-cell lymphoma
Beskrivning

B-Cell Lymphoma CD20 antigen positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079731 (B-Cell Lymphomas)
SNOMED
109979007
UMLS CUI [1,2]
C3888518 (CD20 antigen positive)
confirmed relapsed/refractory disease following autologous transplant
Beskrivning

Autologous hematopoietic stem cell transplant | Recurrent disease | Refractory Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C2193200 (Autologous haematopoietic stem cell transplant)
UMLS CUI [2]
C0277556 (Recurrent disease)
SNOMED
58184002
UMLS CUI [3]
C1514815 (Refractory Disease)
age ≤ 75 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779 (Age)
SNOMED
424144002
LOINC
LP28815-6
performance status 0 or 1
Beskrivning

Performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965 (Performance Status)
creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976 (Creatinine measurement, serum (procedure))
SNOMED
113075003
UMLS CUI [2]
C2711451 (Estimation of creatinine clearance by Cockcroft-Gault formula)
SNOMED
442407001
total bilirubin, ast, and alt ≤ 1.5 x upper limit of normal (unless bilirubin due to gilbert's)
Beskrivning

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Bilirubin Due to Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039 (Serum total bilirubin measurement)
SNOMED
313840000
UMLS CUI [2]
C0201899 (Aspartate aminotransferase measurement)
SNOMED
45896001
UMLS CUI [3]
C0201836 (Alanine aminotransferase measurement)
SNOMED
34608000
UMLS CUI [4,1]
C1705847 (Exception - Property or Attribute)
UMLS CUI [4,2]
C0005437 (Bilirubin)
SNOMED
79706000
LOINC
LP15448-1
UMLS CUI [4,3]
C0678226 (Due to)
SNOMED
42752001
UMLS CUI [4,4]
C0017551 (Gilbert Disease (disorder))
SNOMED
27503000
no active cns disease
Beskrivning

CNS disorder Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007682 (CNS disorder)
SNOMED
23853001
UMLS CUI [1,2]
C0332197 (Absent)
SNOMED
2667000
LOINC
LA9634-2
no detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination
Beskrivning

Lymphoma involves bone marrow Undetectable Bone Marrow Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301440 (Lymphoma involves bone marrow)
SNOMED
397452007
UMLS CUI [1,2]
C3827727 (Undetectable)
UMLS CUI [1,3]
C0005957 (Bone Marrow Examination)
SNOMED
167907006
bone marrow cellularity ≥ 15% on histopathologic bone marrow examination
Beskrivning

Bone marrow cellularity Percentage Bone Marrow Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1561532 (Bone marrow cellularity finding)
UMLS CUI [1,2]
C0439165 (Percent (qualifier value))
SNOMED
118582008
UMLS CUI [1,3]
C0005957 (Bone Marrow Examination)
SNOMED
167907006
availability of adequate stored autologous stem cell product (≥ 2 x 106 cd34+
Beskrivning

Stem cell product Autologous CD34 positive Availability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1706452 (Stem cell product)
LOINC
LP36490-8
UMLS CUI [1,2]
C0439859 (Autologous (qualifier value))
SNOMED
255379001
LOINC
LP21353-5
UMLS CUI [1,3]
C0882849 (Cell positive for CD34 antigen)
SNOMED
116826008
UMLS CUI [1,4]
C0470187 (Availability of)
SNOMED
103328004
cells/kg)
Beskrivning

ID.11

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251 (Exclusion Criteria)
active infection
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450 (Communicable Diseases)
SNOMED
189822004
pregnant woman are excluded from the study
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961 (Pregnancy)
SNOMED
289908002
LOINC
LP75920-6
subjects not using contraceptives are excluded from the study
Beskrivning

Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589 (Contraceptive methods)
SNOMED
13197004
UMLS CUI [1,2]
C0332268 (Lacking)
SNOMED
41277001
anc ≤ 1,500/μl and/or platelet count ≤ 100,000/μl
Beskrivning

Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762 (Absolute neutrophil count)
UMLS CUI [2]
C0032181 (Platelet Count measurement)
SNOMED
61928009
life expectancy of ≤ 2 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671 (Life Expectancy)
prior anti-b-cell radioimmunotherapy (e.g., zevalin or bexxar) [patients who have received prior anti-b-cell monoclonal antibody therapy (e.g., rituximab or epratuzumab) will not be excluded.]
Beskrivning

Radioimmunotherapy Against B cells | Zevalin | Bexxar | Monoclonal Antibody Therapy Against B cells allowed | Rituximab allowed | Epratuzumab allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085101 (Radioimmunotherapy)
SNOMED
118640001
UMLS CUI [1,2]
C0521124 (Against)
SNOMED
65897001
UMLS CUI [1,3]
C0004561 (B-Lymphocytes)
SNOMED
112130006
UMLS CUI [2]
C0919274 (Zevalin)
UMLS CUI [3]
C0919272 (Bexxar)
UMLS CUI [4,1]
C0279694 (Monoclonal Antibody Therapy)
UMLS CUI [4,2]
C0521124 (Against)
SNOMED
65897001
UMLS CUI [4,3]
C0004561 (B-Lymphocytes)
SNOMED
112130006
UMLS CUI [4,4]
C0683607 (allowing)
UMLS CUI [5,1]
C0393022 (rituximab)
SNOMED
108809004
UMLS CUI [5,2]
C0683607 (allowing)
UMLS CUI [6,1]
C1120776 (epratuzumab)
UMLS CUI [6,2]
C0683607 (allowing)
prior total body radiation therapy
Beskrivning

Total body radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0948732 (Total body radiation therapy)
positive human anti-mouse antibody (hama) testing
Beskrivning

Human anti-mouse antibody test Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868744 (Human anti-mouse antibody test)
UMLS CUI [1,2]
C1514241 (Positive Finding)
LOINC
LP21065-5
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Similar models

Eligibility B-Cell Lymphoma NCT00434629

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphoma CD20 antigen positive
Item
cd20 positive b-cell lymphoma
boolean
C0079731 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Autologous hematopoietic stem cell transplant | Recurrent disease | Refractory Disease
Item
confirmed relapsed/refractory disease following autologous transplant
boolean
C2193200 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
Age
Item
age ≤ 75 years
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
performance status 0 or 1
boolean
C1518965 (UMLS CUI [1])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Bilirubin Due to Gilbert Disease
Item
total bilirubin, ast, and alt ≤ 1.5 x upper limit of normal (unless bilirubin due to gilbert's)
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0005437 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0017551 (UMLS CUI [4,4])
CNS disorder Absent
Item
no active cns disease
boolean
C0007682 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Lymphoma involves bone marrow Undetectable Bone Marrow Examination
Item
no detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination
boolean
C1301440 (UMLS CUI [1,1])
C3827727 (UMLS CUI [1,2])
C0005957 (UMLS CUI [1,3])
Bone marrow cellularity Percentage Bone Marrow Examination
Item
bone marrow cellularity ≥ 15% on histopathologic bone marrow examination
boolean
C1561532 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0005957 (UMLS CUI [1,3])
Stem cell product Autologous CD34 positive Availability
Item
availability of adequate stored autologous stem cell product (≥ 2 x 106 cd34+
boolean
C1706452 (UMLS CUI [1,1])
C0439859 (UMLS CUI [1,2])
C0882849 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,4])
ID.11
Item
cells/kg)
boolean
Item Group
C0680251 (UMLS CUI)
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Pregnancy
Item
pregnant woman are excluded from the study
boolean
C0032961 (UMLS CUI [1])
Contraceptive methods Lacking
Item
subjects not using contraceptives are excluded from the study
boolean
C0700589 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Absolute neutrophil count | Platelet Count measurement
Item
anc ≤ 1,500/μl and/or platelet count ≤ 100,000/μl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of ≤ 2 months
boolean
C0023671 (UMLS CUI [1])
Radioimmunotherapy Against B cells | Zevalin | Bexxar | Monoclonal Antibody Therapy Against B cells allowed | Rituximab allowed | Epratuzumab allowed
Item
prior anti-b-cell radioimmunotherapy (e.g., zevalin or bexxar) [patients who have received prior anti-b-cell monoclonal antibody therapy (e.g., rituximab or epratuzumab) will not be excluded.]
boolean
C0085101 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0004561 (UMLS CUI [1,3])
C0919274 (UMLS CUI [2])
C0919272 (UMLS CUI [3])
C0279694 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0004561 (UMLS CUI [4,3])
C0683607 (UMLS CUI [4,4])
C0393022 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C1120776 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Total body radiation therapy
Item
prior total body radiation therapy
boolean
C0948732 (UMLS CUI [1])
Human anti-mouse antibody test Positive
Item
positive human anti-mouse antibody (hama) testing
boolean
C1868744 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
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