Informações:
Falhas:
ID
12754
Descrição
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
Palavras-chave
Versões (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, in Relapse NCT01518517
Eligibility Acute Lymphoblastic Leukemia, in Relapse NCT01518517
- StudyEvent: Eligibility
Similar models
Eligibility Acute Lymphoblastic Leukemia, in Relapse NCT01518517
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])