ID

31534

Beschreibung

Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00989352

Link

https://clinicaltrials.gov/show/NCT00989352

Stichworte

Versionen (2)
  1. 01.09.18 01.09.18 -
  2. 01.09.18 01.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. September 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Primary Non Hodgkin Lymphoma of the Central Nervous System NCT00989352

Englisch

Eligibility Primary Non Hodgkin Lymphoma of the Central Nervous System NCT00989352

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
first diagnosis of pcnsl, histologically confirmed
Beschreibung

Primary central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0280803
age > 65 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
written signed and dated informed consent of the legal representative and - if possible - of the patient
Beschreibung

Informed Consent Patient Representative | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030701
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
manifestations of further lymphoma outside the cns
Beschreibung

Manifestation of Lymphoma Additional | Exception Central Nervous System

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1280464
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3714787
sero-positive for hiv
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
severe pulmonary, cardiac, hepatic, renal impairment
Beschreibung

Pulmonary function impairment Severe | Impairment cardiac Severe | Hepatic impairment Severe | Renal Insufficiency Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858943
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0221099
UMLS CUI [2,2]
C0018787
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0948807
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C1565489
UMLS CUI [4,2]
C0205082
uncontrolled infection
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
neutrophil count < 1.500/µl, platelet count < 100.000/µl
Beschreibung

Neutrophil count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
pulmonary disease with ivc < 55%, dlco < 40%
Beschreibung

Lung disease | Inspiratory Vital Capacity Test | DLCO

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C4085887
UMLS CUI [3]
C1516251
cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
Beschreibung

Cardiac ejection fraction | Cardiac Arrhythmia Malignant Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205282
UMLS CUI [2,3]
C0205318
creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
bilirubin > 2mg/dl
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
ascites or pleural effusion (> 500ml)
Beschreibung

Ascites | Pleural effusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0032227
known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
Beschreibung

Methotrexate allergy | Lomustine allergy | Procarbazine allergy | Hypersensitivity Rituximab | Hypersensitivity Leucovorin | Dexamethasone allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0570693
UMLS CUI [2]
C0570678
UMLS CUI [3]
C0570704
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0393022
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0023413
UMLS CUI [6]
C0571611
participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
known or current drug or alcohol abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Primary Non Hodgkin Lymphoma of the Central Nervous System NCT00989352

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Primary central nervous system lymphoma
Item
first diagnosis of pcnsl, histologically confirmed
boolean
C0280803 (UMLS CUI [1])
Age
Item
age > 65 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent Patient Representative | Informed Consent
Item
written signed and dated informed consent of the legal representative and - if possible - of the patient
boolean
C0021430 (UMLS CUI [1,1])
C0030701 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Manifestation of Lymphoma Additional | Exception Central Nervous System
Item
manifestations of further lymphoma outside the cns
boolean
C1280464 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C3714787 (UMLS CUI [2,2])
HIV Seropositivity
Item
sero-positive for hiv
boolean
C0019699 (UMLS CUI [1])
Pulmonary function impairment Severe | Impairment cardiac Severe | Hepatic impairment Severe | Renal Insufficiency Severe
Item
severe pulmonary, cardiac, hepatic, renal impairment
boolean
C0858943 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0221099 (UMLS CUI [2,1])
C0018787 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0948807 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1565489 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Communicable Disease Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Neutrophil count | Platelet Count measurement
Item
neutrophil count < 1.500/µl, platelet count < 100.000/µl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Lung disease | Inspiratory Vital Capacity Test | DLCO
Item
pulmonary disease with ivc < 55%, dlco < 40%
boolean
C0024115 (UMLS CUI [1])
C4085887 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
Cardiac ejection fraction | Cardiac Arrhythmia Malignant Uncontrolled
Item
cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
boolean
C0232174 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Serum total bilirubin measurement
Item
bilirubin > 2mg/dl
boolean
C1278039 (UMLS CUI [1])
Ascites | Pleural effusion
Item
ascites or pleural effusion (> 500ml)
boolean
C0003962 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
Methotrexate allergy | Lomustine allergy | Procarbazine allergy | Hypersensitivity Rituximab | Hypersensitivity Leucovorin | Dexamethasone allergy
Item
known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
boolean
C0570693 (UMLS CUI [1])
C0570678 (UMLS CUI [2])
C0570704 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0393022 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0023413 (UMLS CUI [5,2])
C0571611 (UMLS CUI [6])
Study Subject Participation Status
Item
participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
boolean
C2348568 (UMLS CUI [1])
Substance Use Disorders
Item
known or current drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
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