ID

13718

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00778375

Nyckelord

Versioner (1)
  1. 2016-03-01 2016-03-01 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

1 mars 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00778375

Engelsk

Eligibility Acute Myeloid Leukemia NCT00778375

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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.

Datatyp

boolean

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

2. age >/= 60 years.

Datatyp

boolean

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

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

Datatyp

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).
Beskrivning

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).

Datatyp

boolean

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

5. sign written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

1. cardiac ejection fraction < 40%.

Datatyp

boolean

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

2. prior therapy with clofarabine or decitabine.

Datatyp

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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
4. pregnancy
Beskrivning

4. pregnancy

Datatyp

boolean

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

5. acute promyelocytic leukemia (apl).

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Eligibility Acute Myeloid Leukemia NCT00778375

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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