ID

24087

Description

A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00474188

Link

https://clinicaltrials.gov/show/NCT00474188

Keywords

  1. 7/25/17 7/25/17 -
Uploaded on

July 25, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Diffuse Large B-cell Lymphoma NCT00474188

Eligibility Diffuse Large B-cell Lymphoma NCT00474188

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy-proven diffuse large b-cell non-hodgkin's lymphoma
Description

Diffuse Large B-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079744
relapsed or refractory to previous therapy for non-hodgkin's lymphoma
Description

Therapeutic procedure Non-Hodgkin Lymphoma | Non-Hodgkin's lymphoma recurrent | Non-Hodgkin Lymphoma Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0024305
UMLS CUI [2]
C0854866
UMLS CUI [3,1]
C0024305
UMLS CUI [3,2]
C0205269
measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
Description

Measurable Disease Cross-sectional imaging | Measurable Disease Diameter Size

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C3824793
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0456389
ecog performance score of 0,1 or 2
Description

ECOG performance status

Data type

boolean

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

Pregnancy Precaution Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1882442
UMLS CUI [1,3]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following laboratory abnormalities.
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l).
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 60,000/mm3 (60 x 109/l).
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum sgot/ast or sgpt/alt 5.0 x upper limit of normal (uln).
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

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

Serum total bilirubin measurement

Data type

boolean

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

Indication Transplantation of autologous hematopoietic stem cell

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1831743
history of active cns lymphoma within the previous 3 months
Description

Central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0742472
subjects not willing or unable to take dvt prophylaxis
Description

Deep Vein Thrombosis Prophylaxis Unwilling | Deep Vein Thrombosis Prophylaxis Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0149871
UMLS CUI [1,2]
C0199176
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0149871
UMLS CUI [2,2]
C0199176
UMLS CUI [2,3]
C1299582
history of other malignancies within the past year
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
positive hiv or active hepatitis b or c
Description

HIV Seropositivity | Hepatitis B | Hepatitis C

Data type

boolean

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

Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT00474188

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma
Item
biopsy-proven diffuse large b-cell non-hodgkin's lymphoma
boolean
C0079744 (UMLS CUI [1])
Therapeutic procedure Non-Hodgkin Lymphoma | Non-Hodgkin's lymphoma recurrent | Non-Hodgkin Lymphoma Unresponsive to Treatment
Item
relapsed or refractory to previous therapy for non-hodgkin's lymphoma
boolean
C0087111 (UMLS CUI [1,1])
C0024305 (UMLS CUI [1,2])
C0854866 (UMLS CUI [2])
C0024305 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
Measurable Disease Cross-sectional imaging | Measurable Disease Diameter Size
Item
measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
boolean
C1513041 (UMLS CUI [1,1])
C3824793 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
ECOG performance status
Item
ecog performance score of 0,1 or 2
boolean
C1520224 (UMLS CUI [1])
Pregnancy Precaution Compliance behavior
Item
willing to follow the pregnancy precautions
boolean
C0032961 (UMLS CUI [1,1])
C1882442 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Laboratory test result abnormal
Item
any of the following laboratory abnormalities.
boolean
C0438215 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l).
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 60,000/mm3 (60 x 109/l).
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
serum sgot/ast or sgpt/alt 5.0 x upper limit of normal (uln).
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum total bilirubin > 2.0 mg/dl (34 µmol/l).
boolean
C1278039 (UMLS CUI [1])
Indication Transplantation of autologous hematopoietic stem cell
Item
subjects who are candidates for and willing to undergo an autologous stem cell transplant.
boolean
C3146298 (UMLS CUI [1,1])
C1831743 (UMLS CUI [1,2])
Central nervous system lymphoma
Item
history of active cns lymphoma within the previous 3 months
boolean
C0742472 (UMLS CUI [1])
Deep Vein Thrombosis Prophylaxis Unwilling | Deep Vein Thrombosis Prophylaxis Unable
Item
subjects not willing or unable to take dvt prophylaxis
boolean
C0149871 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0149871 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Malignant Neoplasms
Item
history of other malignancies within the past year
boolean
C0006826 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
positive hiv or active hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])

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