ID

12804

Descrição

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

Palavras-chave

  1. 21/12/2015 21/12/2015 -
Transferido a

21 de dezembro de 2015

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT01354457

Eligibility Acute Lymphoblastic Leukemia NCT01354457

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-70 years
Descrição

age

Tipo de dados

boolean

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

b-cell acute leukemia

Tipo de dados

boolean

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

cd22+ expression

Tipo de dados

boolean

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

all patients who have experienced relapse or treatment failure

Tipo de dados

boolean

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

at least 15 days since previous treatment

Tipo de dados

boolean

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

ecog performance status

Tipo de dados

boolean

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

creatinine clearance

Tipo de dados

boolean

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

serum bilirubin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
written informed consent
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
t-all
Descrição

t-all

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023493
meningeal involvement
Descrição

meningeal involvement

Tipo de dados

boolean

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

cd22 expression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3815865
hiv positive
Descrição

hiv positive

Tipo de dados

boolean

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

Hepatitis

Tipo de dados

boolean

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

active infection

Tipo de dados

boolean

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

left ventricular ejection fraction

Tipo de dados

boolean

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

contra-indication

Tipo de dados

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
Descrição

malignancy

Tipo de dados

boolean

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

psychological, familial, sociological or geographical condition potentially hampering compliance

Tipo de dados

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
Descrição

study subject participation status

Tipo de dados

boolean

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

informed consent denied

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT01354457

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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