ID

21404

Description

Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00422591

Link

https://clinicaltrials.gov/show/NCT00422591

Keywords

Versions (1)
  1. 4/19/17 4/19/17 -
Uploaded on

April 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00422591

English

Eligibility Leukemia NCT00422591

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00422591
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of 1) aml (who classification definition of >/= 20% blasts). patients with m6 aml with less than 20% blasts are eligible.
Description

Acute Myelocytic Leukemia WHO classification | Acute Myelocytic Leukemia French-American-British Classification | Blast count

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1301142
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C2984084
UMLS CUI [3]
C0523113
2. patients aged 15 to 75 years are eligible. patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for aml. they could have received transfusions, hematopoietic growth factors or vitamins. temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
Description

Age | Chemotherapy naive | Acute Myelocytic Leukemia | Hydrea | Blood Transfusion | Hematopoietic Growth Factors | Vitamins | Pheresis

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0919936
UMLS CUI [3]
C0023467
UMLS CUI [4]
C0591617
UMLS CUI [5]
C0005841
UMLS CUI [6]
C0079490
UMLS CUI [7]
C0042890
UMLS CUI [8]
C0005791
3. ecog ps of 0, 1, 2, or 3 at screening.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl -
Description

Biochemical finding | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0428132
UMLS CUI [2]
C0201976
total bilirubin </= 2.0 mg/dl, unless increase is due to hemolysis - transaminases (sg pt) </= 3x uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
5. ability to understand and provide signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with acute promyelocytic leukemia (apl).
Description

Acute Promyelocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
2. presence of active systemic infection.
Description

Sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0243026
3. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
Description

Comorbidity Interferes with Protocol Compliance | Comorbidity Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
4. nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, iud, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
Description

Breast Feeding | Urine pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Sexual Abstinence | Condoms Partner

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0430059
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0677582
UMLS CUI [8,2]
C0682323
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Similar models

Eligibility Leukemia NCT00422591

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00422591
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute Myelocytic Leukemia WHO classification | Acute Myelocytic Leukemia French-American-British Classification | Blast count
Item
1. diagnosis of 1) aml (who classification definition of >/= 20% blasts). patients with m6 aml with less than 20% blasts are eligible.
boolean
C0023467 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C2984084 (UMLS CUI [2,2])
C0523113 (UMLS CUI [3])
Age | Chemotherapy naive | Acute Myelocytic Leukemia | Hydrea | Blood Transfusion | Hematopoietic Growth Factors | Vitamins | Pheresis
Item
2. patients aged 15 to 75 years are eligible. patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for aml. they could have received transfusions, hematopoietic growth factors or vitamins. temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
boolean
C0001779 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C0023467 (UMLS CUI [3])
C0591617 (UMLS CUI [4])
C0005841 (UMLS CUI [5])
C0079490 (UMLS CUI [6])
C0042890 (UMLS CUI [7])
C0005791 (UMLS CUI [8])
ECOG performance status
Item
3. ecog ps of 0, 1, 2, or 3 at screening.
boolean
C1520224 (UMLS CUI [1])
Biochemical finding | Creatinine measurement, serum
Item
4. serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl -
boolean
C0428132 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin </= 2.0 mg/dl, unless increase is due to hemolysis - transaminases (sg pt) </= 3x uln
boolean
C1278039 (UMLS CUI [1])
Informed Consent
Item
5. ability to understand and provide signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
1. subjects with acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
Sepsis
Item
2. presence of active systemic infection.
boolean
C0243026 (UMLS CUI [1])
Comorbidity Interferes with Protocol Compliance | Comorbidity Interferes with Research results
Item
3. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Breast Feeding | Urine pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Sexual Abstinence | Condoms Partner
Item
4. nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, iud, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
boolean
C0006147 (UMLS CUI [1])
C0430059 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0677582 (UMLS CUI [8,1])
C0682323 (UMLS CUI [8,2])
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