ID

13605

Beschreibung

Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00590187

Link

https://clinicaltrials.gov/show/NCT00590187

Stichworte

Versionen (1)
  1. 19.02.16 19.02.16 -
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19. Februar 2016

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Eligibility Acute Myeloid Leukemia NCT00590187

Englisch

Eligibility Acute Myeloid Leukemia NCT00590187

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
a histologically or pathologically confirmed diagnosis of aml based on who classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or mds with ipss scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
Beschreibung

a histologically or pathologically confirmed diagnosis of aml based on who classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or mds with ipss scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
age 70 years or older for aml and 60 years or older for mds
Beschreibung

age 70 years or older for aml and 60 years or older for mds

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0-2
Beschreibung

eastern cooperative oncology group (ecog) performance status 0-2

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (uln)
Beschreibung

adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (uln)

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x uln; alanine aminotransferase (alt or sgpt) equal to or less than 2.5 x uln (5 x uln if tumor has affected the liver)
Beschreibung

adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x uln; alanine aminotransferase (alt or sgpt) equal to or less than 2.5 x uln (5 x uln if tumor has affected the liver)

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201836
life expectancy reasonably adequate for evaluating the treatment effect
Beschreibung

life expectancy reasonably adequate for evaluating the treatment effect

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
patient must be able to swallow capsules
Beschreibung

patient must be able to swallow capsules

Datentyp

boolean

Alias
UMLS CUI [1]
C0006935
patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
Beschreibung

patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332152
UMLS CUI [3,1]
C0679637
UMLS CUI [3,2]
C0332152
UMLS CUI [4,1]
C0949266
UMLS CUI [4,2]
C0332152
UMLS CUI [5]
C2004454
all men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
Beschreibung

all men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
ability to understand and willingness to sign the informed consent form
Beschreibung

ability to understand and willingness to sign the informed consent form

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
aml is of the sub-type of acute promyelocytic leukemia
Beschreibung

aml is of the sub-type of acute promyelocytic leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023487
having received more than one induction systemic therapy for aml or having received a standard dose or high dose ara-c containing regimen for mds
Beschreibung

having received more than one induction systemic therapy for aml or having received a standard dose or high dose ara-c containing regimen for mds

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C0023467
UMLS CUI [2,1]
C0010711
UMLS CUI [2,2]
C3463824
patients with known central nervous system (cns) involvement by leukemia
Beschreibung

patients with known central nervous system (cns) involvement by leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0449389
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than aml, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. patients receiving intravenous antibiotics for infections that are under control may be included in this study
Beschreibung

uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than aml, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. patients receiving intravenous antibiotics for infections that are under control may be included in this study

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0009488
known to be hiv-positive
Beschreibung

known to be hiv-positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
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Ähnliche Modelle

Eligibility Acute Myeloid Leukemia NCT00590187

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
AML or MDS
Item
a histologically or pathologically confirmed diagnosis of aml based on who classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or mds with ipss scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
age
Item
age 70 years or older for aml and 60 years or older for mds
boolean
C0001779 (UMLS CUI [1])
ecog
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
renal function
Item
adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (uln)
boolean
C0201976 (UMLS CUI [1])
liver function
Item
adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x uln; alanine aminotransferase (alt or sgpt) equal to or less than 2.5 x uln (5 x uln if tumor has affected the liver)
boolean
C1278039 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
life expectancy
Item
life expectancy reasonably adequate for evaluating the treatment effect
boolean
C0023671 (UMLS CUI [1])
capsules
Item
patient must be able to swallow capsules
boolean
C0006935 (UMLS CUI [1])
prior chemotherapy
Item
patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
boolean
C1514457 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0679637 (UMLS CUI [3,1])
C0332152 (UMLS CUI [3,2])
C0949266 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
C2004454 (UMLS CUI [5])
contraception
Item
all men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
boolean
C0700589 (UMLS CUI [1])
informed consent form
Item
ability to understand and willingness to sign the informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
apl
Item
aml is of the sub-type of acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1])
induction systemic therapy for aml or having received a standard dose or high dose ara-c containing regimen for mds
Item
having received more than one induction systemic therapy for aml or having received a standard dose or high dose ara-c containing regimen for mds
boolean
C3179010 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0010711 (UMLS CUI [2,1])
C3463824 (UMLS CUI [2,2])
cns involvement by leukemia
Item
patients with known central nervous system (cns) involvement by leukemia
boolean
C0449389 (UMLS CUI [1])
comorbidity
Item
uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than aml, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. patients receiving intravenous antibiotics for infections that are under control may be included in this study
boolean
C0009488 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
hiv
Item
known to be hiv-positive
boolean
C0019682 (UMLS CUI [1])
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