ID

13718

Description

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

Keywords

Versions (1)
  1. 3/1/16 3/1/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 1, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Acute Myeloid Leukemia NCT00778375

English

Eligibility Acute Myeloid Leukemia NCT00778375

1 forms  
Inclusion Criteria
Description

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.
Description

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.

Data type

boolean

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

2. age >/= 60 years.

Data type

boolean

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

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

Data type

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).
Description

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).

Data type

boolean

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

5. sign written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

1. cardiac ejection fraction < 40%.

Data type

boolean

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

2. prior therapy with clofarabine or decitabine.

Data type

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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0009488
4. pregnancy
Description

4. pregnancy

Data type

boolean

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

5. acute promyelocytic leukemia (apl).

Data type

boolean

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

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

Data type

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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Back to the top of the page

Similar models

Eligibility Acute Myeloid Leukemia NCT00778375

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial