ID

12754

Description

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

Link

https://clinicaltrials.gov/show/NCT01518517

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

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

English

Eligibility Acute Lymphoblastic Leukemia, in Relapse NCT01518517

1 forms  
Inclusion Criteria
Description

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)
Description

Age

Data type

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)
Description

ALL relapse first

Data type

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
Description

Therapy l-asparaginase (E.Coli)

Data type

boolean

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

WHO performance status scale

Data type

boolean

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

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

philadelphia chromosome positive

Data type

boolean

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

Leukaemia recurrent second

Data type

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
Description

Lactating; Patient currently pregnant; Contraception status

Data type

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
Description

chemotherapy limited Comorbidity

Data type

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)
Description

allergy e.coli l-asparaginase

Data type

boolean

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

Transfusion Grade three rank

Data type

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
Description

Antierythrocyte Antibody

Data type

boolean

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

hemolysis; Concomitant Therapy

Data type

boolean

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

yellow fever vaccination

Data type

boolean

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

phenytoin treatment

Data type

boolean

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

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Acute Lymphoblastic Leukemia, in Relapse NCT01518517

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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