ID

13747

Beschrijving

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

Trefwoorden

Versies (1)
  1. 02-03-16 02-03-16 -
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CC BY-NC 3.0

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2 maart 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01065545

Engels

Eligibility Acute Myeloid Leukemia NCT01065545

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

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
Beschrijving

age 55 or older

Datatype

boolean

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

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

Datatype

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.
Beschrijving

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

Datatype

boolean

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

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

Datatype

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.
Beschrijving

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

Datatype

boolean

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

Exclusion Criteria

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

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

Datatype

boolean

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

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

Datatype

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.
Beschrijving

patients must not be receiving any other investigational agents.

Datatype

boolean

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

participants cannot have hepatitis b or c or hiv.

Datatype

boolean

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

patients must not have an uncontrolled infection

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Eligibility Acute Myeloid Leukemia NCT01065545

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