ID

13725

Description

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

Link

https://clinicaltrials.gov/show/NCT00924443

Keywords

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

CC BY-NC 3.0

Uploaded on

March 1, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00924443

English

Eligibility Acute Myeloid Leukemia NCT00924443

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provide signed, written informed consent
Description

provide signed, written informed consent

Data type

boolean

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

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

Data type

boolean

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

male or post-menopausal female ≥ 65 years of age

Data type

boolean

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

unsuitable for intensive chemotherapy

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous treatment with clofarabine
Description

received previous treatment with clofarabine

Data type

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)
Description

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

Data type

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
Description

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

Data type

boolean

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

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

Data type

boolean

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

have an active, uncontrolled systemic infection

Data type

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
Description

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

Data type

boolean

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

have symptomatic central nervous system (cns) involvement

Data type

boolean

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

blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia

Data type

boolean

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

Eligibility Acute Myeloid Leukemia NCT00924443

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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