ID

18014

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00210366

Stichworte

Versionen (1)
  1. 14.10.16 14.10.16 -
Hochgeladen am

14. Oktober 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Lymphoma, B-Cell NCT00210366

Englisch

Eligibility Lymphoma, B-Cell NCT00210366

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Lymphoma, Non-Hodgkin

Datentyp

boolean

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

Disease Localized Central Nervous System | treatment failure

Datentyp

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
Beschreibung

Progressive Disease | Recurrent disease

Datentyp

boolean

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

Methotrexate High dose | Chemotherapy | Therapeutic radiology procedure

Datentyp

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
Beschreibung

Target Lesion Quantity | Measurable Disease 2-Dimensional

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

HIV | Immunologic Deficiency Syndromes

Datentyp

boolean

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

Hepatitis B surface antigen negative | Hepatitis C Antibodies Negative

Datentyp

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)
Beschreibung

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

Datentyp

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)
Beschreibung

Renal function | Creatinine measurement, serum

Datentyp

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)
Beschreibung

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

Datentyp

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%)
Beschreibung

Cardiac function Ventricular Ejection Fraction

Datentyp

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
Beschreibung

Condition Affecting Protocol Compliance

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Investigational New Drugs

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Lymphoma, B-Cell NCT00210366

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video