ID

14004

Description

Idarubicin Overcomes MDR1 Induced Chemoresistance With Higher Induction Remission Rate and Quality Than Daunorubicin in Acute Myeloid Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01889407

Link

https://clinicaltrials.gov/show/NCT01889407

Keywords

  1. 3/21/16 3/21/16 -
Uploaded on

March 21, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT01889407

Eligibility Acute Myeloid Leukemia NCT01889407

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Diagnosis of aml (who classification definition of >/= 20% blasts).
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
Patients aged 16 to 60 years are eligible. patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for aml. they could have received transfusion, 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

Data type

boolean

Alias
UMLS CUI [1]
C0001779
the relative expression level of mdr1 mrna (mdr1/gapdh ratio using the quantitative real-time pcr) in pre-treated bone marrow samples should over 0.016 (cut-off point from our results of preliminary experiment data)
Description

ABCB1 gene

Data type

boolean

Alias
UMLS CUI [1]
C0376622
ECOG performance status of 0, 1, 2 at screening
Description

ECOG performance status

Data type

boolean

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

Creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0010294
Total bilirubin </= 2.0 mg/dl, unless increase is due to hemolysis -
Description

Bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0005437
Transaminases (sg pt) </= 3x uln
Description

Transaminases

Data type

boolean

Alias
UMLS CUI [1]
C0002594
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
Subjects with acute promyelocytic leukemia (apl)
Description

Acute Promyelocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
Presence of active systemic infection
Description

Systemic infection

Data type

boolean

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

Medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0009488
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

Positive urine pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0430059

Similar models

Eligibility Acute Myeloid Leukemia NCT01889407

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
Diagnosis of aml (who classification definition of >/= 20% blasts).
boolean
C0023467 (UMLS CUI [1])
Age
Item
Patients aged 16 to 60 years are eligible. patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for aml. they could have received transfusion, 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])
ABCB1 gene
Item
the relative expression level of mdr1 mrna (mdr1/gapdh ratio using the quantitative real-time pcr) in pre-treated bone marrow samples should over 0.016 (cut-off point from our results of preliminary experiment data)
boolean
C0376622 (UMLS CUI [1])
ECOG performance status
Item
ECOG performance status of 0, 1, 2 at screening
boolean
C1520224 (UMLS CUI [1])
Creatinine
Item
Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl -
boolean
C0010294 (UMLS CUI [1])
Bilirubin
Item
Total bilirubin </= 2.0 mg/dl, unless increase is due to hemolysis -
boolean
C0005437 (UMLS CUI [1])
Transaminases
Item
Transaminases (sg pt) </= 3x uln
boolean
C0002594 (UMLS CUI [1])
Informed Consent
Item
Ability to understand and provide signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
Subjects with acute promyelocytic leukemia (apl)
boolean
C0023487 (UMLS CUI [1])
Systemic infection
Item
Presence of active systemic infection
boolean
C0243026 (UMLS CUI [1])
Medical condition
Item
Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
boolean
C0525058 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Positive urine pregnancy test
Item
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
C0430059 (UMLS CUI [1])

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