ID

21760

Beschreibung

A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00413036

Link

https://clinicaltrials.gov/show/NCT00413036

Stichworte

Versionen (1)
  1. 28.04.17 28.04.17 -
Hochgeladen am

28. April 2017

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin's NCT00413036

Englisch

Eligibility Lymphoma, Non-Hodgkin's NCT00413036

1 Formulare  
Criteria
Beschreibung

Criteria

biopsy proven aggressive non-hodgkin's lymphoma
Beschreibung

Aggressive Non-Hodgkin Lymphoma Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1332225
UMLS CUI [1,2]
C0005558
follicular center lymphoma grade 3.
Beschreibung

Follicular Lymphoma Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
diffuse large b-cell lymphoma.
Beschreibung

Diffuse Large B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0079744
mantle cell lymphoma.
Beschreibung

mantle cell lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0334634
transformed lymphoma.
Beschreibung

Lymphoma Transformed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0457344
relapsed or refractory to previous therapy for lymphoma
Beschreibung

Therapeutic procedure Lymphoma Relapse | Therapeutic procedure Lymphoma refractory

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0024299
UMLS CUI [2,3]
C0205269
at least one prior combination chemotherapy regime
Beschreibung

Combination Chemotherapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521750
UMLS CUI [1,2]
C1265611
measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
Beschreibung

Measurable Disease Diameter Cross-sectional imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C3824793
eastern cooperative oncology group (ecog) performance score of 0, 1 or 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
willing to follow the pregnancy precautions
Beschreibung

Contraceptive methods Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
key exclusion criteria
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any of the following laboratory abnormalities.
Beschreibung

LABORATORY ABNORMALITIES

Datentyp

boolean

Alias
UMLS CUI [1]
C1853129
absolute neutrophil count (anc) < 1,500 cells/mm^3 (1.5*10^9/l).
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 60,000/mm^3 (60*10^9/l).
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
calculated creatinine clearance of <50ml/min
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
serum glutamic oxaloacetic transaminase/aspartate aminotransferase (sgot/ast) or serum glutamic pyruvic transaminase/alanine transaminase (sgpt/alt) 5.0 times upper limit of normal (uln).
Beschreibung

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
serum total bilirubin > 2.0 mg/dl (34 µmol/l)/conjugated bilirubin >0.8mg/dl.
Beschreibung

Serum total bilirubin measurement | Conjugated bilirubin level

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0428439
subjects who are candidates for and willing to undergo an autologous stem cell transplant.
Beschreibung

Autologous hematopoietic stem cell transplant Receive Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2193200
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0600109
history of active central nervous system (cns) lymphoma within the previous 6 months
Beschreibung

Central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0742472
history of other malignancies within the past year
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
positive human immunodeficiency virus (hiv) or active hepatitis b or c
Beschreibung

HIV Seropositivity | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Ähnliche Modelle

Eligibility Lymphoma, Non-Hodgkin's NCT00413036

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Aggressive Non-Hodgkin Lymphoma Biopsy
Item
biopsy proven aggressive non-hodgkin's lymphoma
boolean
C1332225 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
follicular center lymphoma grade 3.
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Diffuse Large B-Cell Lymphoma
Item
diffuse large b-cell lymphoma.
boolean
C0079744 (UMLS CUI [1])
mantle cell lymphoma
Item
mantle cell lymphoma.
boolean
C0334634 (UMLS CUI [1])
Lymphoma Transformed
Item
transformed lymphoma.
boolean
C0024299 (UMLS CUI [1,1])
C0457344 (UMLS CUI [1,2])
Therapeutic procedure Lymphoma Relapse | Therapeutic procedure Lymphoma refractory
Item
relapsed or refractory to previous therapy for lymphoma
boolean
C0087111 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
Combination Chemotherapy Quantity
Item
at least one prior combination chemotherapy regime
boolean
C1521750 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Measurable Disease Diameter Cross-sectional imaging
Item
measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
boolean
C1513041 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C3824793 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance score of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods Willing
Item
willing to follow the pregnancy precautions
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
key exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
LABORATORY ABNORMALITIES
Item
any of the following laboratory abnormalities.
boolean
C1853129 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) < 1,500 cells/mm^3 (1.5*10^9/l).
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 60,000/mm^3 (60*10^9/l).
boolean
C0032181 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance of <50ml/min
boolean
C2711451 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
serum glutamic oxaloacetic transaminase/aspartate aminotransferase (sgot/ast) or serum glutamic pyruvic transaminase/alanine transaminase (sgpt/alt) 5.0 times upper limit of normal (uln).
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum total bilirubin measurement | Conjugated bilirubin level
Item
serum total bilirubin > 2.0 mg/dl (34 µmol/l)/conjugated bilirubin >0.8mg/dl.
boolean
C1278039 (UMLS CUI [1])
C0428439 (UMLS CUI [2])
Autologous hematopoietic stem cell transplant Receive Willing
Item
subjects who are candidates for and willing to undergo an autologous stem cell transplant.
boolean
C2193200 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Central nervous system lymphoma
Item
history of active central nervous system (cns) lymphoma within the previous 6 months
boolean
C0742472 (UMLS CUI [1])
Malignant Neoplasms
Item
history of other malignancies within the past year
boolean
C0006826 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
positive human immunodeficiency virus (hiv) or active hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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