ID

18014

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00210366

Nyckelord

Versioner (1)
  1. 2016-10-14 2016-10-14 -
Uppladdad den

14 oktober 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell NCT00210366

Engelsk

Eligibility Lymphoma, B-Cell NCT00210366

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Lymphoma, Non-Hodgkin

Datatyp

boolean

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

Disease Localized Central Nervous System | treatment failure

Datatyp

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
Beskrivning

Progressive Disease | Recurrent disease

Datatyp

boolean

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

Methotrexate High dose | Chemotherapy | Therapeutic radiology procedure

Datatyp

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
Beskrivning

Target Lesion Quantity | Measurable Disease 2-Dimensional

Datatyp

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
Beskrivning

Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

HIV | Immunologic Deficiency Syndromes

Datatyp

boolean

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

Hepatitis B surface antigen negative | Hepatitis C Antibodies Negative

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

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)
Beskrivning

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

Datatyp

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%)
Beskrivning

Cardiac function Ventricular Ejection Fraction

Datatyp

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
Beskrivning

Condition Affecting Protocol Compliance

Datatyp

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.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Sex Behavior Contraceptive methods

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Investigational New Drugs

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Lymphoma, B-Cell NCT00210366

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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