ID

13718

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00778375

Keywords

versioni (1)
  1. 01/03/16 01/03/16 -
Titolare del copyright

CC BY-NC 3.0

Caricato su

1 marzo 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00778375

Inglese

Eligibility Acute Myeloid Leukemia NCT00778375

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Descrizione

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.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C3463824
UMLS CUI [3]
C1514463
2. age >/= 60 years.
Descrizione

2. age >/= 60 years.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
3. eastern cooperative oncology group (ecog) performance status </= 2.
Descrizione

3. eastern cooperative oncology group (ecog) performance status </= 2.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
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).
Descrizione

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).

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
5. sign written informed consent
Descrizione

5. sign written informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. cardiac ejection fraction < 40%.
Descrizione

1. cardiac ejection fraction < 40%.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232174
2. prior therapy with clofarabine or decitabine.
Descrizione

2. prior therapy with clofarabine or decitabine.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0092777
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C0049065
UMLS CUI [2,2]
C1514463
3. active and uncontrolled disease/infection as judged by the treating physician.
Descrizione

3. active and uncontrolled disease/infection as judged by the treating physician.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
4. pregnancy
Descrizione

4. pregnancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
5. acute promyelocytic leukemia (apl).
Descrizione

5. acute promyelocytic leukemia (apl).

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023487
6. women of childbearing potential and men who do not practice contraception.
Descrizione

6. women of childbearing potential and men who do not practice contraception.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
7. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Descrizione

7. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
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Similar models

Eligibility Acute Myeloid Leukemia NCT00778375

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
written informed consent
Item
5. sign written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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