ID

13154

Description

A Study of Ribavirin to Treat M4 and M5 Acute Myelocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00559091

Link

https://clinicaltrials.gov/show/NCT00559091

Keywords

  1. 1/20/16 1/20/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 20, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Acute Myelocytic Leukemia NCT00559091

Eligibility Acute Myelocytic Leukemia NCT00559091

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
a diagnosis of acute myeloid leukemia (aml), either m4 or m5 subtype de novo or resulting from a transformation from mds or a myeloproliferative disorder.
Description

AML diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0023467
patients with aml who (a) have failed primary therapy -defined as failing two induction chemotherapies, (b) have relapsed or (c) are not suitable for intensive induction chemotherapy will be eligible. or
Description

patients with aml who (a) have failed primary therapy -defined as failing two induction chemotherapies, (b) have relapsed or (c) are not suitable for intensive induction chemotherapy will be eligible. or

Data type

boolean

Alias
UMLS CUI [1]
C0023467
patients with aml blast crisis from cml if they are not suitable candidates for intensive induction chemotherapy or have failed imatinib mesylate or
Description

AML blast crisis from CML

Data type

boolean

Alias
UMLS CUI [1]
C0023474
patients with secondary aml after mds if they are not suitable candidates for intensive induction chemotherapy.
Description

secondary aml after mds

Data type

boolean

Alias
UMLS CUI [1]
C3463824
ecog 0,1,2, or 3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 12 weeks.
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate renal and hepatic function
Description

renal and hepatic function

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled central nervous system involvement by aml
Description

uncontrolled central nervous system involvement by aml

Data type

boolean

Alias
UMLS CUI [1]
C3714787
active cardiovascular disease as defined by nyha class iii-iv categorization.
Description

NYHA

Data type

boolean

Alias
UMLS CUI [1]
C1275491
intercurrent illness or medical condition precluding safe administration of ribavirin.
Description

intercurrent illness or medical condition precluding safe administration of ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0035525
received any previous therapy within 28 days prior to study entry.hydrea is permitted but must be stopped 7 days prior to starting study drug.
Description

received any previous therapy within 28 days prior to study entry.hydrea is permitted but must be stopped 7 days prior to starting study drug

Data type

boolean

Alias
UMLS CUI [1]
C0020402
known infection with hiv.
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019682

Similar models

Eligibility Acute Myelocytic Leukemia NCT00559091

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML diagnosis
Item
a diagnosis of acute myeloid leukemia (aml), either m4 or m5 subtype de novo or resulting from a transformation from mds or a myeloproliferative disorder.
boolean
C0023467 (UMLS CUI [1])
patients with aml who (a) have failed primary therapy -defined as failing two induction chemotherapies, (b) have relapsed or (c) are not suitable for intensive induction chemotherapy will be eligible. or
Item
patients with aml who (a) have failed primary therapy -defined as failing two induction chemotherapies, (b) have relapsed or (c) are not suitable for intensive induction chemotherapy will be eligible. or
boolean
C0023467 (UMLS CUI [1])
AML blast crisis from CML
Item
patients with aml blast crisis from cml if they are not suitable candidates for intensive induction chemotherapy or have failed imatinib mesylate or
boolean
C0023474 (UMLS CUI [1])
secondary aml after mds
Item
patients with secondary aml after mds if they are not suitable candidates for intensive induction chemotherapy.
boolean
C3463824 (UMLS CUI [1])
ECOG performance status
Item
ecog 0,1,2, or 3
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy > 12 weeks.
boolean
C0023671 (UMLS CUI [1])
renal and hepatic function
Item
adequate renal and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
uncontrolled central nervous system involvement by aml
Item
uncontrolled central nervous system involvement by aml
boolean
C3714787 (UMLS CUI [1])
NYHA
Item
active cardiovascular disease as defined by nyha class iii-iv categorization.
boolean
C1275491 (UMLS CUI [1])
intercurrent illness or medical condition precluding safe administration of ribavirin
Item
intercurrent illness or medical condition precluding safe administration of ribavirin.
boolean
C0035525 (UMLS CUI [1])
received any previous therapy within 28 days prior to study entry.hydrea is permitted but must be stopped 7 days prior to starting study drug
Item
received any previous therapy within 28 days prior to study entry.hydrea is permitted but must be stopped 7 days prior to starting study drug.
boolean
C0020402 (UMLS CUI [1])
HIV
Item
known infection with hiv.
boolean
C0019682 (UMLS CUI [1])

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