ID

41069

Descrição

Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT01272245

Link

https://clinicaltrials.gov/show/NCT01272245

Palavras-chave

Versões (1)
  1. 19/06/2020 19/06/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de junho de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Leukemia NCT01272245

Inglês

Eligibility Leukemia NCT01272245

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01272245
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. previously untreated aml (>/= 20% blasts). 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. a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
Descrição

AML Untreated | Blasts Percentage | High risk MYELODYSPLASTIC SYNDROME IPSS | hydroxyurea | Biological treatment | Targeted Therapy | FLT3 Inhibitor | kinase inhibitor | Azacitidine | Hematopoietic Cell Growth Factors | Cytarabine Dose U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0368761
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C4319571
UMLS CUI [3,2]
C3463824
UMLS CUI [3,3]
C2827405
UMLS CUI [4]
C0020402
UMLS CUI [5]
C1531518
UMLS CUI [6]
C2985566
UMLS CUI [7]
C4086297
UMLS CUI [8]
C3537035
UMLS CUI [9]
C0004475
UMLS CUI [10]
C0079490
UMLS CUI [11,1]
C0010711
UMLS CUI [11,2]
C0178602
UMLS CUI [11,3]
C0456683
2. age >/= 60 years.
Descrição

Age

Tipo de dados

boolean

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

ECOG performance status

Tipo de dados

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).
Descrição

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
5. patients must be willing and able to review, understand, and provide written consent before starting therapy.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

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), diabetes mellitus, or congestive heart failure.
Descrição

Heart Diseases New York Heart Association Classification | Ischemia | Condition cardiac Uncontrolled | Angina Pectoris | Cardiac Arrhythmia Treatment required for | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Independent of Antihypertensive Agents | Diabetes Mellitus | Congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0022116
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0018787
UMLS CUI [3,3]
C0205318
UMLS CUI [4]
C0002962
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0332121
UMLS CUI [6]
C1868885
UMLS CUI [7]
C0871470
UMLS CUI [8]
C0428883
UMLS CUI [9,1]
C0332291
UMLS CUI [9,2]
C0003364
UMLS CUI [10]
C0011849
UMLS CUI [11]
C0018802
2. myocardial infarction in the previous 12 weeks (from the start of treatment).
Descrição

Myocardial Infarction

Tipo de dados

boolean

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

Disease Uncontrolled | Communicable Disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
4. pregnancy.
Descrição

Pregnancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
5. acute promyelocytic leukemia (apl).
Descrição

Acute Promyelocytic Leukemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023487
6. women of childbearing potential and men who do not practice contraception. non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
Descrição

Childbearing Potential Contraceptive methods Absent | Gender Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
7. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Descrição

Childbearing Potential Contraceptive methods Willing | Gender Contraceptive methods Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0600109
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Similar models

Eligibility Leukemia NCT01272245

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01272245
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
AML Untreated | Blasts Percentage | High risk MYELODYSPLASTIC SYNDROME IPSS | hydroxyurea | Biological treatment | Targeted Therapy | FLT3 Inhibitor | kinase inhibitor | Azacitidine | Hematopoietic Cell Growth Factors | Cytarabine Dose U/day
Item
1. previously untreated aml (>/= 20% blasts). 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. a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0368761 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C4319571 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C2827405 (UMLS CUI [3,3])
C0020402 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C2985566 (UMLS CUI [6])
C4086297 (UMLS CUI [7])
C3537035 (UMLS CUI [8])
C0004475 (UMLS CUI [9])
C0079490 (UMLS CUI [10])
C0010711 (UMLS CUI [11,1])
C0178602 (UMLS CUI [11,2])
C0456683 (UMLS CUI [11,3])
Age
Item
2. age >/= 60 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum
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
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
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])
Item Group
C0680251 (UMLS CUI)
Heart Diseases New York Heart Association Classification | Ischemia | Condition cardiac Uncontrolled | Angina Pectoris | Cardiac Arrhythmia Treatment required for | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Independent of Antihypertensive Agents | Diabetes Mellitus | 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), diabetes mellitus, or congestive heart failure.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0022116 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0018787 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0002962 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0332121 (UMLS CUI [5,2])
C1868885 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
C0332291 (UMLS CUI [9,1])
C0003364 (UMLS CUI [9,2])
C0011849 (UMLS CUI [10])
C0018802 (UMLS CUI [11])
Myocardial Infarction
Item
2. myocardial infarction in the previous 12 weeks (from the start of treatment).
boolean
C0027051 (UMLS CUI [1])
Disease Uncontrolled | Communicable Disease Uncontrolled
Item
3. active and uncontrolled disease/infection as judged by the treating physician.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Pregnancy
Item
4. pregnancy.
boolean
C0032961 (UMLS CUI [1])
Acute Promyelocytic Leukemia
Item
5. acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Absent | Gender Contraceptive methods Absent
Item
6. women of childbearing potential and men who do not practice contraception. non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods Willing | Gender Contraceptive methods Willing
Item
7. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
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