ID

13718

Beschrijving

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

Trefwoorden

Versies (1)
  1. 01-03-16 01-03-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

1 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00778375

Engels

Eligibility Acute Myeloid Leukemia NCT00778375

1 Formulieren  
Inclusion Criteria
Beschrijving

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.
Beschrijving

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.

Datatype

boolean

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

2. age >/= 60 years.

Datatype

boolean

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

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

Datatype

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).
Beschrijving

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).

Datatype

boolean

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

5. sign written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

1. cardiac ejection fraction < 40%.

Datatype

boolean

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

2. prior therapy with clofarabine or decitabine.

Datatype

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.
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
4. pregnancy
Beschrijving

4. pregnancy

Datatype

boolean

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

5. acute promyelocytic leukemia (apl).

Datatype

boolean

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

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

Datatype

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.
Beschrijving

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

Datatype

boolean

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

Eligibility Acute Myeloid Leukemia NCT00778375

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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