ID

13747

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01065545

Nyckelord

Versioner (1)
  1. 2016-03-02 2016-03-02 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

2 mars 2016

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01065545

Engelsk

Eligibility Acute Myeloid Leukemia NCT01065545

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

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
Beskrivning

age 55 or older

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Exclusion Criteria

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

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

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

patients must not be receiving any other investigational agents.

Datatyp

boolean

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

participants cannot have hepatitis b or c or hiv.

Datatyp

boolean

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

patients must not have an uncontrolled infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Acute Myeloid Leukemia NCT01065545

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