ID

12804

Beschreibung

Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+; ODM derived from: https://clinicaltrials.gov/show/NCT01354457

Link

https://clinicaltrials.gov/show/NCT01354457

Stichworte

  1. 21.12.15 21.12.15 -
Hochgeladen am

21. Dezember 2015

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT01354457

Eligibility Acute Lymphoblastic Leukemia NCT01354457

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-70 years
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
b-all (oms) with >=20 percent of blasts in bone marrow
Beschreibung

b-cell acute leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0279593
cd22+ expression >=70 percent of the blast population
Beschreibung

cd22+ expression

Datentyp

boolean

Alias
UMLS CUI [1]
C3815865
all previously treated all patients who have experienced relapse or treatment failure
Beschreibung

all patients who have experienced relapse or treatment failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0277556
at least 15 days since previous treatment
Beschreibung

at least 15 days since previous treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332168
performance status 0 - 2
Beschreibung

ecog performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
creatinine clearance >= 50 ml/min (cockroft formula).
Beschreibung

creatinine clearance

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
serum bilirubin <= 30 mmol/l
Beschreibung

serum bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
written informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
t-all
Beschreibung

t-all

Datentyp

boolean

Alias
UMLS CUI [1]
C0023493
meningeal involvement
Beschreibung

meningeal involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948840
cd22 expression on tumor cells or < 70 percent
Beschreibung

cd22 expression

Datentyp

boolean

Alias
UMLS CUI [1]
C3815865
hiv positive
Beschreibung

hiv positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
active hepatitis b or c
Beschreibung

Hepatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0019163
active infection within 7 days of starting treatment
Beschreibung

active infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
left ventricular ejection fraction < 50 percent.
Beschreibung

left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
contra-indication to 90y-dota-hll2
Beschreibung

contra-indication

Datentyp

boolean

Alias
UMLS CUI [1]
C1301624
previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
Beschreibung

malignancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Beschreibung

psychological, familial, sociological or geographical condition potentially hampering compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
participation at the same time in another study in which investigational drugs are used
Beschreibung

study subject participation status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
absence of written informed consent
Beschreibung

informed consent denied

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430

Ähnliche Modelle

Eligibility Acute Lymphoblastic Leukemia NCT01354457

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age 18-70 years
boolean
C0001779 (UMLS CUI [1])
b-cell acute leukemia
Item
b-all (oms) with >=20 percent of blasts in bone marrow
boolean
C0279593 (UMLS CUI [1])
cd22+ expression
Item
cd22+ expression >=70 percent of the blast population
boolean
C3815865 (UMLS CUI [1])
all patients who have experienced relapse or treatment failure
Item
all previously treated all patients who have experienced relapse or treatment failure
boolean
C0023449 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
at least 15 days since previous treatment
Item
at least 15 days since previous treatment
boolean
C0920425 (UMLS CUI [1,1])
C0332168 (UMLS CUI [1,2])
ecog performance status
Item
performance status 0 - 2
boolean
C1520224 (UMLS CUI [1])
creatinine clearance
Item
creatinine clearance >= 50 ml/min (cockroft formula).
boolean
C0373595 (UMLS CUI [1])
serum bilirubin
Item
serum bilirubin <= 30 mmol/l
boolean
C1278039 (UMLS CUI [1])
informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
t-all
Item
t-all
boolean
C0023493 (UMLS CUI [1])
meningeal involvement
Item
meningeal involvement
boolean
C0948840 (UMLS CUI [1])
cd22 expression
Item
cd22 expression on tumor cells or < 70 percent
boolean
C3815865 (UMLS CUI [1])
hiv positive
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis
Item
active hepatitis b or c
boolean
C0019196 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
active infection
Item
active infection within 7 days of starting treatment
boolean
C0009450 (UMLS CUI [1])
left ventricular ejection fraction
Item
left ventricular ejection fraction < 50 percent.
boolean
C0428772 (UMLS CUI [1])
contra-indication
Item
contra-indication to 90y-dota-hll2
boolean
C1301624 (UMLS CUI [1])
malignancy
Item
previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
boolean
C0006826 (UMLS CUI [1])
psychological, familial, sociological or geographical condition potentially hampering compliance
Item
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
study subject participation status
Item
participation at the same time in another study in which investigational drugs are used
boolean
C2348568 (UMLS CUI [1])
informed consent denied
Item
absence of written informed consent
boolean
C0021430 (UMLS CUI [1])

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