ID

39084

Beskrivning

R-ESHAP Followed by Autologous Transplantation for Refractory or Relapsed Diffused Large B-cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01278602

Länk

https://clinicaltrials.gov/show/NCT01278602

Nyckelord

Versioner (1)
  1. 2019-11-29 2019-11-29 -
Rättsinnehavare

See clinicaltrials.gov

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29 november 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma NCT01278602

Engelsk

Eligibility Diffuse Large B-cell Lymphoma NCT01278602

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age range: 18-65 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histological confirmed diffuse large b-cell lymphoma
Beskrivning

Diffuse Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079744
refractory or first relapsed disease
Beskrivning

Refractory Disease | First Relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2]
C4054953
prior anthracycline exposure
Beskrivning

Exposure to Anthracyclines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0282564
measurable disease
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status 0-1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of more than 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
bone marrow function: anc≧1.5×109/l, plt≧100×109/l, hb≧90g/l
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
liver function: total bilirubin, alt and ast <1.5×unl
Beskrivning

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
renal function: cr<1.5×unl, ccr≧50ml/min
Beskrivning

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
no contraindication for transplantation
Beskrivning

Medical contraindication Absent Transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0040732
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of cns and bone marrow involvement
Beskrivning

Central Nervous System Involvement | Bone Marrow Involvement

Datatyp

boolean

Alias
UMLS CUI [1]
C4050309
UMLS CUI [2]
C1517677
more than 1 type of chemotherapy regimens exposure
Beskrivning

Chemotherapy Type Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1265611
high level of hbv dna
Beskrivning

HBV DNA increased

Datatyp

boolean

Alias
UMLS CUI [1]
C1262159
contraindication of high-dose methylprednisolone
Beskrivning

Medical contraindication Methylprednisolone High dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025815
UMLS CUI [1,3]
C0444956
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Beskrivning

Cancer Other | Exception Basal cell carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1880198
history of allergic reaction/hypersensitivity to rituximab
Beskrivning

Allergic Reaction Rituximab | Hypersensitivity Rituximab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0393022
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0393022
significant active infection
Beskrivning

Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT01278602

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age range: 18-65 years old
boolean
C0001779 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma
Item
histological confirmed diffuse large b-cell lymphoma
boolean
C0079744 (UMLS CUI [1])
Refractory Disease | First Relapse
Item
refractory or first relapsed disease
boolean
C1514815 (UMLS CUI [1])
C4054953 (UMLS CUI [2])
Exposure to Anthracyclines
Item
prior anthracycline exposure
boolean
C0332157 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
bone marrow function: anc≧1.5×109/l, plt≧100×109/l, hb≧90g/l
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
liver function: total bilirubin, alt and ast <1.5×unl
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
renal function: cr<1.5×unl, ccr≧50ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Medical contraindication Absent Transplantation
Item
no contraindication for transplantation
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0040732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Central Nervous System Involvement | Bone Marrow Involvement
Item
evidence of cns and bone marrow involvement
boolean
C4050309 (UMLS CUI [1])
C1517677 (UMLS CUI [2])
Chemotherapy Type Quantity
Item
more than 1 type of chemotherapy regimens exposure
boolean
C0392920 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
HBV DNA increased
Item
high level of hbv dna
boolean
C1262159 (UMLS CUI [1])
Medical contraindication Methylprednisolone High dose
Item
contraindication of high-dose methylprednisolone
boolean
C1301624 (UMLS CUI [1,1])
C0025815 (UMLS CUI [1,2])
C0444956 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer Other | Exception Basal cell carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured
Item
history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
Allergic Reaction Rituximab | Hypersensitivity Rituximab
Item
history of allergic reaction/hypersensitivity to rituximab
boolean
C1527304 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
Communicable Disease
Item
significant active infection
boolean
C0009450 (UMLS CUI [1])
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