ID

13808

Description

Decitabine and Plerixafor in Elderly Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01352650

Link

https://clinicaltrials.gov/show/NCT01352650

Keywords

Versions (1)
  1. 3/7/16 3/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 7, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01352650

English

Eligibility Acute Myeloid Leukemia NCT01352650

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
unequivocal pathologic diagnosis of aml (≥ 20% blasts in the bone marrow based on who criteria) excluding: i) acute promyelocytic leukemia t(15;17)(q22;q12); pml-rara; ii)acute myeloid leukemia with t(8;21)(q22;q22); runx1-runxt1; iii) acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); cbfb-myh11.
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0023487
aml patients with an antecedent hematologic disorder or myelodysplastic syndrome (mds)are eligible for treatment on this trial provided that they have not received prior treatment with decitabine or prior cytotoxic treatment for aml.
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0332152
UMLS CUI [3]
C0049065
aml patients with therapy-related myeloid neoplasms (t-mn) are eligible if they have not received chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for >6 months.
Description

therapy-related myeloid neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C2939461
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2924519
UMLS CUI [2]
C0392920
age ≥ 60 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability to understand and willingness to sign a written informed consent document.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with decitabine
Description

prior treatment with decitabine

Data type

boolean

Alias
UMLS CUI [1,1]
C0049065
UMLS CUI [1,2]
C1514463
prior treatment with plerixafor
Description

prior treatment with plerixafor

Data type

boolean

Alias
UMLS CUI [1,1]
C1955474
UMLS CUI [1,2]
C1514463
ongoing treatment for another malignancy.
Description

concurrent therapy for another malignancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205420
patients with good-risk molecular or cytogenetics features
Description

molecular or cytogenetics features

Data type

boolean

Alias
UMLS CUI [1]
C0010802
UMLS CUI [2]
C1521991
patient has a medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational drug treatment.
Description

comorbidity limiting study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patient has a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
Description

comorbidity limiting consent and completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patient has an inability or unwillingness, in the opinion of the investigator, to comply with the protocol requirements.
Description

compliance behaviour

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Acute Myeloid Leukemia NCT01352650

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
unequivocal pathologic diagnosis of aml (≥ 20% blasts in the bone marrow based on who criteria) excluding: i) acute promyelocytic leukemia t(15;17)(q22;q12); pml-rara; ii)acute myeloid leukemia with t(8;21)(q22;q22); runx1-runxt1; iii) acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); cbfb-myh11.
boolean
C0023467 (UMLS CUI [1])
C0023487 (UMLS CUI [2])
AML
Item
aml patients with an antecedent hematologic disorder or myelodysplastic syndrome (mds)are eligible for treatment on this trial provided that they have not received prior treatment with decitabine or prior cytotoxic treatment for aml.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0049065 (UMLS CUI [3])
therapy-related myeloid neoplasms
Item
aml patients with therapy-related myeloid neoplasms (t-mn) are eligible if they have not received chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for >6 months.
boolean
C2939461 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2924519 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
age
Item
age ≥ 60 years.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
ability to understand and willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior treatment with decitabine
Item
prior treatment with decitabine
boolean
C0049065 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
prior treatment with plerixafor
Item
prior treatment with plerixafor
boolean
C1955474 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
concurrent therapy for another malignancy
Item
ongoing treatment for another malignancy.
boolean
C0006826 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
molecular or cytogenetics features
Item
patients with good-risk molecular or cytogenetics features
boolean
C0010802 (UMLS CUI [1])
C1521991 (UMLS CUI [2])
comorbidity limiting study protocol
Item
patient has a medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational drug treatment.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
comorbidity limiting consent and completion
Item
patient has a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
compliance behaviour
Item
patient has an inability or unwillingness, in the opinion of the investigator, to comply with the protocol requirements.
boolean
C1321605 (UMLS CUI [1])
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