ID

31534

Description

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

Keywords

Versions (2)
  1. 9/1/18 9/1/18 -
  2. 9/1/18 9/1/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 1, 2018

DOI

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License

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

English

Eligibility Primary Non Hodgkin Lymphoma of the Central Nervous System NCT00989352

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Primary central nervous system lymphoma

Data type

boolean

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

Age

Data type

boolean

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

Informed Consent Patient Representative | Informed Consent

Data type

boolean

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

Exclusion Criteria

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

Manifestation of Lymphoma Additional | Exception Central Nervous System

Data type

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
Description

HIV Seropositivity

Data type

boolean

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

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

Data type

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
Description

Communicable Disease Uncontrolled

Data type

boolean

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

Neutrophil count | Platelet Count measurement

Data type

boolean

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

Lung disease | Inspiratory Vital Capacity Test | DLCO

Data type

boolean

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

Cardiac ejection fraction | Cardiac Arrhythmia Malignant Uncontrolled

Data type

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
Description

Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

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

Serum total bilirubin measurement

Data type

boolean

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

Ascites | Pleural effusion

Data type

boolean

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

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

Data type

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
Description

Study Subject Participation Status

Data type

boolean

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

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Primary Non Hodgkin Lymphoma of the Central Nervous System NCT00989352

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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