ID

18014

Description

Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00210366

Link

https://clinicaltrials.gov/show/NCT00210366

Keywords

Versions (1)
  1. 10/14/16 10/14/16 -
Uploaded on

October 14, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Lymphoma, B-Cell NCT00210366

English

Eligibility Lymphoma, B-Cell NCT00210366

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological diagnosis of non-hodgkin's lymphoma
Description

Lymphoma, Non-Hodgkin

Data type

boolean

Alias
UMLS CUI [1]
C0024305
disease exclusively localised into the cns at first diagnosis and failure
Description

Disease Localized Central Nervous System | treatment failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392752
UMLS CUI [1,3]
C3714787
UMLS CUI [2]
C0162643
progressive or recurrent disease
Description

Progressive Disease | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C0277556
previous treatment with hdmtx containing cht and/or rt
Description

Methotrexate High dose | Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
presence of at least one target lesion, bidimensionally measurable
Description

Target Lesion Quantity | Measurable Disease 2-Dimensional

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
age 18 - 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status < 3 (appendix 1).
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
no known hiv disease or immunodeficiency
Description

HIV | Immunologic Deficiency Syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0021051
hbsag-negative and ab anti-hcv-negative patients.
Description

Hepatitis B surface antigen negative | Hepatitis C Antibodies Negative

Data type

boolean

Alias
UMLS CUI [1]
C0919711
UMLS CUI [2,1]
C0166049
UMLS CUI [2,2]
C1513916
adequate bone marrow function (plt > 100000 mm3, hb > 9 g/dl, anc > 2.000 mm3)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0019046
UMLS CUI [4]
C0948762
adequate renal function (serum creatinine < 2 times unl)
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
adequate hepatic function (sgot/sgpt < 3 times unl, bilirubin and alkaline phosphatase < 2 times unl)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201850
adequate cardiac function (vef ≥ 50%)
Description

Cardiac function Ventricular Ejection Fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0042508
absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Description

Condition Affecting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
non-pregnant and non-lactating status for female patients. adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
Description

Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036864
UMLS CUI [3,3]
C0700589
no previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.
Description

Malignant Neoplasms | Carcinoma in situ of uterine cervix Cure of disease Surgical | Basal cell carcinoma | Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0851140
UMLS CUI [2,2]
C0679252
UMLS CUI [2,3]
C0543467
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0553723
no concurrent treatment with other experimental drugs.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
informed consent signed by the patient before registration
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Back to the top of the page

Similar models

Eligibility Lymphoma, B-Cell NCT00210366

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Non-Hodgkin
Item
histological or cytological diagnosis of non-hodgkin's lymphoma
boolean
C0024305 (UMLS CUI [1])
Disease Localized Central Nervous System | treatment failure
Item
disease exclusively localised into the cns at first diagnosis and failure
boolean
C0012634 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C3714787 (UMLS CUI [1,3])
C0162643 (UMLS CUI [2])
Progressive Disease | Recurrent disease
Item
progressive or recurrent disease
boolean
C1335499 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Methotrexate High dose | Chemotherapy | Therapeutic radiology procedure
Item
previous treatment with hdmtx containing cht and/or rt
boolean
C0025677 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Target Lesion Quantity | Measurable Disease 2-Dimensional
Item
presence of at least one target lesion, bidimensionally measurable
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
Age
Item
age 18 - 75 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status < 3 (appendix 1).
boolean
C1520224 (UMLS CUI [1])
HIV | Immunologic Deficiency Syndromes
Item
no known hiv disease or immunodeficiency
boolean
C0019682 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
Hepatitis B surface antigen negative | Hepatitis C Antibodies Negative
Item
hbsag-negative and ab anti-hcv-negative patients.
boolean
C0919711 (UMLS CUI [1])
C0166049 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Bone Marrow function | Platelet Count measurement | Hemoglobin | Absolute neutrophil count
Item
adequate bone marrow function (plt > 100000 mm3, hb > 9 g/dl, anc > 2.000 mm3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
adequate renal function (serum creatinine < 2 times unl)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement
Item
adequate hepatic function (sgot/sgpt < 3 times unl, bilirubin and alkaline phosphatase < 2 times unl)
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Cardiac function Ventricular Ejection Fraction
Item
adequate cardiac function (vef ≥ 50%)
boolean
C0232164 (UMLS CUI [1,1])
C0042508 (UMLS CUI [1,2])
Condition Affecting Protocol Compliance
Item
absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods
Item
non-pregnant and non-lactating status for female patients. adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0036864 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Malignant Neoplasms | Carcinoma in situ of uterine cervix Cure of disease Surgical | Basal cell carcinoma | Squamous cell carcinoma of skin
Item
no previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2,1])
C0679252 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0007117 (UMLS CUI [3])
C0553723 (UMLS CUI [4])
Investigational New Drugs
Item
no concurrent treatment with other experimental drugs.
boolean
C0013230 (UMLS CUI [1])
Informed Consent
Item
informed consent signed by the patient before registration
boolean
C0021430 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial