ID

12754

Beskrivning

GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01518517

Länk

https://clinicaltrials.gov/show/NCT01518517

Nyckelord

Versioner (1)
  1. 2015-12-21 2015-12-21 -
Uppladdad den

21 december 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia, in Relapse NCT01518517

Engelsk

Eligibility Acute Lymphoblastic Leukemia, in Relapse NCT01518517

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient from 1 to 55 years old (children and adolescents from 1 to 17 years/ adults from 18 to 55 years)
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients with 1st all relapse, which could be either isolated bone marrow relapse, or combined (medullary and extra-medullary) relapse, or extra-medullary isolated relapse; or lymphoblastic lymphoma (excepted burkitt lymphoma) or failure to all first line treatment (no complete remission obtained)
Beskrivning

ALL relapse first

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2367454
UMLS CUI [1,2]
C0205435
patient previously treated with free e.coli l-asparaginase form or pegylated one
Beskrivning

Therapy l-asparaginase (E.Coli)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3255308
performance status ≤ 2 (who score)
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
patient informed and consent provided (the 2 parents need to consent when children are below 18)
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
all t(9;22) and/or bcr-abl positive (philadelphia chromosome positive)
Beskrivning

philadelphia chromosome positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0856536
patient with 2nd relapse and over
Beskrivning

Leukaemia recurrent second

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920028
UMLS CUI [1,2]
C0205436
women of childbearing potential without effective contraception as well as pregnant or breast feeding women
Beskrivning

Lactating; Patient currently pregnant; Contraception status

Datatyp

boolean

Alias
UMLS CUI [1]
C2828358
UMLS CUI [2]
C0549206
UMLS CUI [3]
C0420837
patient unable to receive treatments used in global chemotherapy protocols, due to general or visceral conditions such as:severe cardiac impairment (nyha grade 3 or 4 cardiomyopathy)/serum creatinine 2 x uln unless related to all /alt or ast 5 x uln unless related to all /pancreatitis history /other malignancy that all / severe infection, hiv positive, active hepatitis related to b or c virus infection / trisomy 21 / other serious conditions according to investigator's opinion
Beskrivning

chemotherapy limited Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
known grade 4 allergic reaction to e.coli l-asparaginase (according nci-ctcae, version 3.0)
Beskrivning

allergy e.coli l-asparaginase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3255308
history of grade 3 transfusional incident
Beskrivning

Transfusion Grade three rank

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0450094
presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient
Beskrivning

Antierythrocyte Antibody

Datatyp

boolean

Alias
UMLS CUI [1]
C0236506
patient under concomitant treatment likely to cause hemolysis
Beskrivning

hemolysis; Concomitant Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0019054
UMLS CUI [2]
C1707479
patient undergoing yellow fever vaccination
Beskrivning

yellow fever vaccination

Datatyp

boolean

Alias
UMLS CUI [1]
C0199823
patient under phenytoin treatment
Beskrivning

phenytoin treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0747579
patient included in previous clinical study less than 6 weeks ago
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Acute Lymphoblastic Leukemia, in Relapse NCT01518517

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient from 1 to 55 years old (children and adolescents from 1 to 17 years/ adults from 18 to 55 years)
boolean
C0001779 (UMLS CUI [1])
ALL relapse first
Item
patients with 1st all relapse, which could be either isolated bone marrow relapse, or combined (medullary and extra-medullary) relapse, or extra-medullary isolated relapse; or lymphoblastic lymphoma (excepted burkitt lymphoma) or failure to all first line treatment (no complete remission obtained)
boolean
C2367454 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
Therapy l-asparaginase (E.Coli)
Item
patient previously treated with free e.coli l-asparaginase form or pegylated one
boolean
C0087111 (UMLS CUI [1,1])
C3255308 (UMLS CUI [1,2])
WHO performance status scale
Item
performance status ≤ 2 (who score)
boolean
C1298650 (UMLS CUI [1])
informed consent
Item
patient informed and consent provided (the 2 parents need to consent when children are below 18)
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
philadelphia chromosome positive
Item
all t(9;22) and/or bcr-abl positive (philadelphia chromosome positive)
boolean
C0856536 (UMLS CUI [1])
Leukaemia recurrent second
Item
patient with 2nd relapse and over
boolean
C0920028 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
Lactating; Patient currently pregnant; Contraception status
Item
women of childbearing potential without effective contraception as well as pregnant or breast feeding women
boolean
C2828358 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
C0420837 (UMLS CUI [3])
chemotherapy limited Comorbidity
Item
patient unable to receive treatments used in global chemotherapy protocols, due to general or visceral conditions such as:severe cardiac impairment (nyha grade 3 or 4 cardiomyopathy)/serum creatinine 2 x uln unless related to all /alt or ast 5 x uln unless related to all /pancreatitis history /other malignancy that all / severe infection, hiv positive, active hepatitis related to b or c virus infection / trisomy 21 / other serious conditions according to investigator's opinion
boolean
C3665472 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
allergy e.coli l-asparaginase
Item
known grade 4 allergic reaction to e.coli l-asparaginase (according nci-ctcae, version 3.0)
boolean
C0020517 (UMLS CUI [1,1])
C3255308 (UMLS CUI [1,2])
Transfusion Grade three rank
Item
history of grade 3 transfusional incident
boolean
C1879316 (UMLS CUI [1,1])
C0450094 (UMLS CUI [1,2])
Antierythrocyte Antibody
Item
presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient
boolean
C0236506 (UMLS CUI [1])
hemolysis; Concomitant Therapy
Item
patient under concomitant treatment likely to cause hemolysis
boolean
C0019054 (UMLS CUI [1])
C1707479 (UMLS CUI [2])
yellow fever vaccination
Item
patient undergoing yellow fever vaccination
boolean
C0199823 (UMLS CUI [1])
phenytoin treatment
Item
patient under phenytoin treatment
boolean
C0747579 (UMLS CUI [1])
Study Subject Participation Status
Item
patient included in previous clinical study less than 6 weeks ago
boolean
C2348568 (UMLS CUI [1])
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