ID

25958

Beschreibung

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

Stichworte

Versionen (2)
  1. 02.10.17 02.10.17 -
  2. 04.10.17 04.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. Oktober 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

Keine Kommentare

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility B-Cell Lymphoma NCT00434629

Englisch

Eligibility B-Cell Lymphoma NCT00434629

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
cd20 positive b-cell lymphoma
Beschreibung

B-Cell Lymphoma CD20 antigen positive

Datentyp

boolean

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

Autologous hematopoietic stem cell transplant | Recurrent disease | Refractory Disease

Datentyp

boolean

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

Age

Datentyp

boolean

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

Performance status

Datentyp

boolean

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

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

CNS disorder Absent

Datentyp

boolean

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

Lymphoma involves bone marrow Undetectable Bone Marrow Examination

Datentyp

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
Beschreibung

Bone marrow cellularity Percentage Bone Marrow Examination

Datentyp

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+
Beschreibung

Stem cell product Autologous CD34 positive Availability

Datentyp

boolean

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

ID.11

Datentyp

boolean

Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Beschreibung

Communicable Disease

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Contraceptive methods Lacking

Datentyp

boolean

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

Absolute neutrophil count | Platelet Count measurement

Datentyp

boolean

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

Life Expectancy

Datentyp

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.]
Beschreibung

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

Datentyp

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
Beschreibung

Total body radiation therapy

Datentyp

boolean

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

Human anti-mouse antibody test Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868744
UMLS CUI [1,2]
C1514241
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility B-Cell Lymphoma NCT00434629

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video