ID

13725

Beskrivning

A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable; ODM derived from: https://clinicaltrials.gov/show/NCT00924443

Länk

https://clinicaltrials.gov/show/NCT00924443

Nyckelord

  1. 2016-03-01 2016-03-01 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

1 mars 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Acute Myeloid Leukemia NCT00924443

Eligibility Acute Myeloid Leukemia NCT00924443

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
provide signed, written informed consent
Beskrivning

provide signed, written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
have untreated aml according to world health organization (who) classification
Beskrivning

have untreated aml according to world health organization (who) classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
male or post-menopausal female ≥ 65 years of age
Beskrivning

male or post-menopausal female ≥ 65 years of age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
unsuitable for intensive chemotherapy
Beskrivning

unsuitable for intensive chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
be able to comply with study procedures and follow-up examination
Beskrivning

be able to comply with study procedures and follow-up examination

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
Beskrivning

male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0015895
have adequate liver and renal function as indicated by certain laboratory values
Beskrivning

have adequate liver and renal function as indicated by certain laboratory values

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0232804
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous treatment with clofarabine
Beskrivning

received previous treatment with clofarabine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0092777
UMLS CUI [1,2]
C1514463
are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
Beskrivning

are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0001617
have received prior treatment for leukemia. growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
Beskrivning

have received prior treatment for leukemia. growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
have a psychiatric disorder that would interfere with consent, study participation, or follow-up
Beskrivning

have a psychiatric disorder that would interfere with consent, study participation, or follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
have an active, uncontrolled systemic infection
Beskrivning

have an active, uncontrolled systemic infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
Beskrivning

are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
have symptomatic central nervous system (cns) involvement
Beskrivning

have symptomatic central nervous system (cns) involvement

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
Beskrivning

blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0005699
UMLS CUI [2]
C0023487

Similar models

Eligibility Acute Myeloid Leukemia NCT00924443

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
written informed consent
Item
provide signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
untreated aml
Item
have untreated aml according to world health organization (who) classification
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
age, post-menopausal
Item
male or post-menopausal female ≥ 65 years of age
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
unsuitable for intensive chemotherapy
Item
unsuitable for intensive chemotherapy
boolean
C0392920 (UMLS CUI [1])
compliance behavior
Item
be able to comply with study procedures and follow-up examination
boolean
C1321605 (UMLS CUI [1])
contraception
Item
male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
boolean
C0700589 (UMLS CUI [1])
C0015895 (UMLS CUI [2])
liver and renal function
Item
have adequate liver and renal function as indicated by certain laboratory values
boolean
C0232741 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
previous treatment with clofarabine
Item
received previous treatment with clofarabine
boolean
C0092777 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
other chemotherapy or corticosteroids
Item
are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
boolean
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])
prior treatment
Item
have received prior treatment for leukemia. growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
boolean
C1514463 (UMLS CUI [1])
have a psychiatric disorder that would interfere with consent, study participation, or follow-up
Item
have a psychiatric disorder that would interfere with consent, study participation, or follow-up
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
active, uncontrolled systemic infection
Item
have an active, uncontrolled systemic infection
boolean
C0009488 (UMLS CUI [1])
participation status
Item
are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
boolean
C2348568 (UMLS CUI [1])
cns leukemia
Item
have symptomatic central nervous system (cns) involvement
boolean
C1332884 (UMLS CUI [1])
blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
Item
blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
boolean
C0005699 (UMLS CUI [1])
C0023487 (UMLS CUI [2])

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