ID

26002

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00434629

Trefwoorden

Versies (2)
  1. 02-10-17 02-10-17 -
  2. 04-10-17 04-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility B-Cell Lymphoma NCT00434629

Engels

Eligibility B-Cell Lymphoma NCT00434629

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
cd20 positive b-cell lymphoma
Beschrijving

B-Cell Lymphoma CD20 antigen positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C3888518
confirmed relapsed/refractory disease following autologous transplant
Beschrijving

Autologous hematopoietic stem cell transplant | Recurrent disease | Refractory Disease

Datatype

boolean

Alias
UMLS CUI [1]
C2193200
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
age ≤ 75 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
performance status 0 or 1
Beschrijving

Performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
total bilirubin, ast, and alt ≤ 1.5 x upper limit of normal (unless bilirubin due to gilbert's)
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0005437
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0017551
no active cns disease
Beschrijving

CNS disorder Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0332197
no detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination
Beschrijving

Lymphoma involves bone marrow Undetectable Bone Marrow Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301440
UMLS CUI [1,2]
C3827727
UMLS CUI [1,3]
C0005957
bone marrow cellularity ≥ 15% on histopathologic bone marrow examination
Beschrijving

Bone marrow cellularity Percentage Bone Marrow Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C1561532
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0005957
availability of adequate stored autologous stem cell product (≥ 2 x 106 cd34+
Beschrijving

Stem cell product Autologous CD34 positive Availability

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706452
UMLS CUI [1,2]
C0439859
UMLS CUI [1,3]
C0882849
UMLS CUI [1,4]
C0470187
cells/kg)
Beschrijving

ID.11

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Beschrijving

Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
pregnant woman are excluded from the study
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
subjects not using contraceptives are excluded from the study
Beschrijving

Contraceptive methods Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332268
anc ≤ 1,500/μl and/or platelet count ≤ 100,000/μl
Beschrijving

Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
life expectancy of ≤ 2 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
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.]
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085101
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0004561
UMLS CUI [2]
C0919274
UMLS CUI [3]
C0919272
UMLS CUI [4,1]
C0279694
UMLS CUI [4,2]
C0521124
UMLS CUI [4,3]
C0004561
UMLS CUI [4,4]
C0683607
UMLS CUI [5,1]
C0393022
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C1120776
UMLS CUI [6,2]
C0683607
prior total body radiation therapy
Beschrijving

Total body radiation therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0948732
positive human anti-mouse antibody (hama) testing
Beschrijving

Human anti-mouse antibody test Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C1868744
UMLS CUI [1,2]
C1514241
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Similar models

Eligibility B-Cell Lymphoma NCT00434629

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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