ID

13747

Description

The Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01065545

Link

https://clinicaltrials.gov/show/NCT01065545

Keywords

Versions (1)
  1. 3/2/16 3/2/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 2, 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 NCT01065545

English

Eligibility Acute Myeloid Leukemia NCT01065545

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of acute myeloid leukemia, in first or second remission.
Description

diagnosis of acute myeloid leukemia, in first or second remission.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0544452
UMLS CUI [1,3]
C0205435
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0544452
UMLS CUI [2,3]
C0205436
age 55 or older
Description

age 55 or older

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have given signed, informed consent prior to registration on study.
Description

patients must have given signed, informed consent prior to registration on study.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
participants must have attained a complete remission (cr) to induction chemotherapy and are not good candidates for further intensive chemotherapy or a transplant.
Description

participants must have attained a complete remission (cr) to induction chemotherapy and are not good candidates for further intensive chemotherapy or a transplant.

Data type

boolean

Alias
UMLS CUI [1]
C0677874
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Description

female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032976
male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Description

male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Data type

boolean

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0032976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a diagnosis of acute promyelocytic leukemia are not eligible.
Description

patients with a diagnosis of acute promyelocytic leukemia are not eligible.

Data type

boolean

Alias
UMLS CUI [1]
C0023487
participants cannot be currently receiving chemotherapy, radiation therapy, or immunotherapy.
Description

participants cannot be currently receiving chemotherapy, radiation therapy, or immunotherapy.

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205420
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205420
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0205420
patients must not be receiving any other investigational agents.
Description

patients must not be receiving any other investigational agents.

Data type

boolean

Alias
UMLS CUI [1]
C1875319
participants cannot have hepatitis b or c or hiv.
Description

participants cannot have hepatitis b or c or hiv.

Data type

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196
patients must not have an uncontrolled infection
Description

patients must not have an uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Back to the top of the page

Similar models

Eligibility Acute Myeloid Leukemia NCT01065545

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML in first or second remission
Item
diagnosis of acute myeloid leukemia, in first or second remission.
boolean
C0023467 (UMLS CUI [1,1])
C0544452 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0023467 (UMLS CUI [2,1])
C0544452 (UMLS CUI [2,2])
C0205436 (UMLS CUI [2,3])
age
Item
age 55 or older
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
patients must have given signed, informed consent prior to registration on study.
boolean
C0021430 (UMLS CUI [1])
complete remission
Item
participants must have attained a complete remission (cr) to induction chemotherapy and are not good candidates for further intensive chemotherapy or a transplant.
boolean
C0677874 (UMLS CUI [1])
childbearing potential negative pregnancy test
Item
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
boolean
C3831118 (UMLS CUI [1])
C0032976 (UMLS CUI [2])
contraception duration
Item
male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
boolean
C0449238 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
APL
Item
patients with a diagnosis of acute promyelocytic leukemia are not eligible.
boolean
C0023487 (UMLS CUI [1])
concurrent therapy
Item
participants cannot be currently receiving chemotherapy, radiation therapy, or immunotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0205420 (UMLS CUI [3,2])
investigational agents
Item
patients must not be receiving any other investigational agents.
boolean
C1875319 (UMLS CUI [1])
hiv, hepatitis b or c
Item
participants cannot have hepatitis b or c or hiv.
boolean
C0019682 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
infection
Item
patients must not have an uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
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