ID

12100

Description

Omacetaxine and Decitabine in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT02141477

Link

https://clinicaltrials.gov/show/NCT02141477

Keywords

Versions (1)
  1. 9/22/15 9/22/15 - Julian Varghese
Uploaded on

September 22, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT02141477

English

Eligibility Leukemia NCT02141477

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02141477
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. previously untreated aml (>/= 20% blasts) or aml m6. patients with high-risk (intermediate-2 or high by ipss or >/= 10% blasts) mds will also be eligible. prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. no prior chemotherapy is allowed except for a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
Description

Acute Erythroblastic Leukemia | Leukemia, Myelocytic, Acute; Did not receive therapy or drug for | Myelodysplastic-Myeloproliferative Diseases | Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0023440
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C1301355
UMLS CUI [4]
C1514457
2. age >/= 70 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. ecog performance status </= 2.
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. adequate hepatic (serum total bilirubin </= 1.5 x uln, sgpt and/or sgot </= 2.5 x uln) and renal function (creatinine </= 2.0 mg/dl).
Description

Serum total bilirubin measurement | SGOT - Glutamate oxaloacetate transaminase | SGPT - Glutamate pyruvate transaminase | SGPT - Glutamate pyruvate transaminase | Creatinine measurement, serum (procedure)

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0242192
UMLS CUI [3]
C0376147
UMLS CUI [4]
C0376147
UMLS CUI [5]
C0201976
5. patients must be willing and able to review, understand, and provide written consent before starting therapy.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
6. men of childbearing potential who agree to use contraception prior to study entry and for the duration of participation.
Description

Childbearing Potential | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nyha class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus, or congestive heart failure.
Description

New York Heart Association Classification | Cardiac Arrhythmia | Uncontrolled hypertension | Diabetic - poor control | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0003811
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0421258
UMLS CUI [5]
C0018802
2. myocardial infarction in the previous 12 weeks (from the start of treatment).
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
3. active and uncontrolled disease/infection as judged by the treating physician.
Description

Disease condition determination, uncontrolled | Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0184774
UMLS CUI [2]
C0009450
4. acute promyelocytic leukemia (apl).
Description

acute promyelocytic leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023487
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Similar models

Eligibility Leukemia NCT02141477

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02141477
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute Erythroblastic Leukemia | Leukemia, Myelocytic, Acute; Did not receive therapy or drug for | Myelodysplastic-Myeloproliferative Diseases | Prior Chemotherapy
Item
1. previously untreated aml (>/= 20% blasts) or aml m6. patients with high-risk (intermediate-2 or high by ipss or >/= 10% blasts) mds will also be eligible. prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. no prior chemotherapy is allowed except for a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
boolean
C0023440 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C1301355 (UMLS CUI [3])
C1514457 (UMLS CUI [4])
age
Item
2. age >/= 70 years.
boolean
C0001779 (UMLS CUI [1])
ecog performance status
Item
3. ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Serum total bilirubin measurement | SGOT - Glutamate oxaloacetate transaminase | SGPT - Glutamate pyruvate transaminase | SGPT - Glutamate pyruvate transaminase | Creatinine measurement, serum (procedure)
Item
4. adequate hepatic (serum total bilirubin </= 1.5 x uln, sgpt and/or sgot </= 2.5 x uln) and renal function (creatinine </= 2.0 mg/dl).
boolean
C1278039 (UMLS CUI [1])
C0242192 (UMLS CUI [2])
C0376147 (UMLS CUI [3])
C0376147 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Informed Consent
Item
5. patients must be willing and able to review, understand, and provide written consent before starting therapy.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential | Contraceptive methods
Item
6. men of childbearing potential who agree to use contraception prior to study entry and for the duration of participation.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
New York Heart Association Classification | Cardiac Arrhythmia | Uncontrolled hypertension | Diabetic - poor control | Congestive heart failure
Item
1. nyha class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus, or congestive heart failure.
boolean
C1275491 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
Myocardial Infarction
Item
2. myocardial infarction in the previous 12 weeks (from the start of treatment).
boolean
C0027051 (UMLS CUI [1])
Disease condition determination, uncontrolled | Communicable Diseases
Item
3. active and uncontrolled disease/infection as judged by the treating physician.
boolean
C0184774 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
acute promyelocytic leukemia
Item
4. acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
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