Informações:
Falhas:
ID
13718
Descrição
Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00778375
Link
https://clinicaltrials.gov/show/NCT00778375
Palavras-chave
Versões (1)
- 01/03/2016 01/03/2016 -
Titular dos direitos
CC BY-NC 3.0
Transferido a
1 de março de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00778375
Eligibility Acute Myeloid Leukemia NCT00778375
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myeloid Leukemia NCT00778375
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
previously untreated aml and high-risk mds
Item
1. previously untreated aml and high-risk mds (>/= 10% blasts or >/= ipss intermediate-2). prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2])
C1514463 (UMLS CUI [3])
C0332155 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2])
C1514463 (UMLS CUI [3])
age
Item
2. age >/= 60 years.
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
3. eastern cooperative oncology group (ecog) performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
hepatic and renal function
Item
4. adequate hepatic (serum total bilirubin </= 1.5 x uln, serum glutamate pyruvate transaminase (sgpt) and/or serum glutamate oxaloacetate transaminase (sgot) </= 2.5 x uln) and renal function (creatinine </= 1.5 mg/dl).
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
written informed consent
Item
5. sign written informed consent
boolean
C0021430 (UMLS CUI [1])
cardiac ejection fraction
Item
1. cardiac ejection fraction < 40%.
boolean
C0232174 (UMLS CUI [1])
prior therapy with clofarabine or decitabine
Item
2. prior therapy with clofarabine or decitabine.
boolean
C0092777 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0049065 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1514463 (UMLS CUI [1,2])
C0049065 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
active and uncontrolled disease/infection
Item
3. active and uncontrolled disease/infection as judged by the treating physician.
boolean
C0009488 (UMLS CUI [1])
pregnancy
Item
4. pregnancy
boolean
C0032961 (UMLS CUI [1])
APL
Item
5. acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
women of childbearing potential and men who do not practice contraception
Item
6. women of childbearing potential and men who do not practice contraception.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
Item
7. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])