ID

17912

Description

Clofarabine Plus Cytarabine in Patients With Previously Untreated Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00065143

Link

https://clinicaltrials.gov/show/NCT00065143

Keywords

Versions (1)
  1. 10/8/16 10/8/16 -
Uploaded on

October 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid NCT00065143

English

Eligibility Leukemia, Myeloid NCT00065143

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously untreated acute myeloid leukemia (aml) or high-risk myelodysplastic syndrome (mds) (> 10% blasts). prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
Description

Acute Myelocytic Leukemia untreated | MYELODYSPLASTIC SYNDROME High risk | Blast count procedure | Prior Therapy | hydroxyurea | Chemotherapy, single agent | decitabine | Hematopoietic Cell Growth Factors | Biological treatment | Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0332167
UMLS CUI [3]
C0523113
UMLS CUI [4]
C1514463
UMLS CUI [5]
C0020402
UMLS CUI [6]
C3846440
UMLS CUI [7]
C0049065
UMLS CUI [8]
C0079490
UMLS CUI [9]
C1531518
UMLS CUI [10]
C2985566
age > 50 years to < 74 years (diploid cytogenetics) and < 69 years (abnormal cytogenetics).
Description

Age | Cytogenetic Analysis Diploidy | Cytogenetic Analysis Abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0752095
UMLS CUI [2,2]
C0012568
UMLS CUI [3,1]
C0752095
UMLS CUI [3,2]
C0205161
ecog performance status </= 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
sign a written informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
adequate liver function (total bilirubin < 2mg/dl, sgpt or sgot < x 4 uln) and renal function (serum creatinine < 2mg/dl).
Description

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

Data type

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
male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient is of childbearing potential. non-childbearing is defined as >= 1 year postmenopausal or surgically sterilized).
Description

Fertility Contraceptive methods | Contraception, Barrier | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0004764
UMLS CUI [3]
C3873750
UMLS CUI [4]
C0042241
UMLS CUI [5]
C0493327
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430061
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430057
UMLS CUI [8]
C0232970
UMLS CUI [9]
C0015787
patients who are considered to require immediate induction (rapidly rising wbc >/= 50,000 and/or organ involvement as per the assessment of the treating physician) can be treated without final cytogenetic results and pretreatment assessment of cardiac ejection fraction (muga or echocardiogram) if by history and physical examination patients have </= nyha class ii disease.
Description

Neoadjuvant Therapy Immediate Patient need for | WBC RISING Rapid | organ involvement | Cytogenetic Analysis | Cardiac ejection fraction | Multiple gated acquisition scanning | Echocardiogram | Physical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0205253
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C0750397
UMLS CUI [2,2]
C0456962
UMLS CUI [3]
C0457576
UMLS CUI [4]
C0752095
UMLS CUI [5]
C0232174
UMLS CUI [6]
C0521317
UMLS CUI [7]
C2243117
UMLS CUI [8]
C0031809
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
aml with the following cytogenetic abnormalities: t(15;17), t(8;21), inv(16). cytogenetic results do not need to be available if immediate induction is required (see inclusion #7).
Description

Leukemia, Myelocytic, Acute | Chromosome Aberrations | t(15;17)(PML,RARA) | t(8;21) | inv(16)

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0008625
UMLS CUI [3]
C1979990
UMLS CUI [4]
C3897139
UMLS CUI [5]
C3897144
cardiac ejection fraction < 30%. pretreatment assessment of ejection fraction is not necessary if immediate induction is required as long as by history and physical examination patients have </= nyha class ii disease (see inclusion #7).
Description

Cardiac ejection fraction | Physical Examination

Data type

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0031809
active and uncontrolled infection or any other severe concurrent disease considered life-threatening, or which, in the judgement of the investigator and after discussion with the principal investigator, would make the patient inappropriate for entry into the study.
Description

Communicable Disease Uncontrolled | Comorbidity Severe Life Threatening | Comorbidity Severe Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C2826244
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C2348568
UMLS CUI [3,4]
C1548788
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Similar models

Eligibility Leukemia, Myeloid NCT00065143

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute Myelocytic Leukemia untreated | MYELODYSPLASTIC SYNDROME High risk | Blast count procedure | Prior Therapy | hydroxyurea | Chemotherapy, single agent | decitabine | Hematopoietic Cell Growth Factors | Biological treatment | Targeted Therapy
Item
previously untreated acute myeloid leukemia (aml) or high-risk myelodysplastic syndrome (mds) (> 10% blasts). prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0523113 (UMLS CUI [3])
C1514463 (UMLS CUI [4])
C0020402 (UMLS CUI [5])
C3846440 (UMLS CUI [6])
C0049065 (UMLS CUI [7])
C0079490 (UMLS CUI [8])
C1531518 (UMLS CUI [9])
C2985566 (UMLS CUI [10])
Age | Cytogenetic Analysis Diploidy | Cytogenetic Analysis Abnormal
Item
age > 50 years to < 74 years (diploid cytogenetics) and < 69 years (abnormal cytogenetics).
boolean
C0001779 (UMLS CUI [1])
C0752095 (UMLS CUI [2,1])
C0012568 (UMLS CUI [2,2])
C0752095 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
sign a written informed consent form.
boolean
C0021430 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver function (total bilirubin < 2mg/dl, sgpt or sgot < x 4 uln) and renal function (serum creatinine < 2mg/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])
Fertility Contraceptive methods | Contraception, Barrier | Latex condom | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Postmenopausal state | Female Sterilization
Item
male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient is of childbearing potential. non-childbearing is defined as >= 1 year postmenopausal or surgically sterilized).
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2])
C3873750 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0493327 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
C0232970 (UMLS CUI [8])
C0015787 (UMLS CUI [9])
Neoadjuvant Therapy Immediate Patient need for | WBC RISING Rapid | organ involvement | Cytogenetic Analysis | Cardiac ejection fraction | Multiple gated acquisition scanning | Echocardiogram | Physical Examination
Item
patients who are considered to require immediate induction (rapidly rising wbc >/= 50,000 and/or organ involvement as per the assessment of the treating physician) can be treated without final cytogenetic results and pretreatment assessment of cardiac ejection fraction (muga or echocardiogram) if by history and physical examination patients have </= nyha class ii disease.
boolean
C0600558 (UMLS CUI [1,1])
C0205253 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0750397 (UMLS CUI [2,1])
C0456962 (UMLS CUI [2,2])
C0457576 (UMLS CUI [3])
C0752095 (UMLS CUI [4])
C0232174 (UMLS CUI [5])
C0521317 (UMLS CUI [6])
C2243117 (UMLS CUI [7])
C0031809 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Leukemia, Myelocytic, Acute | Chromosome Aberrations | t(15;17)(PML,RARA) | t(8;21) | inv(16)
Item
aml with the following cytogenetic abnormalities: t(15;17), t(8;21), inv(16). cytogenetic results do not need to be available if immediate induction is required (see inclusion #7).
boolean
C0023467 (UMLS CUI [1])
C0008625 (UMLS CUI [2])
C1979990 (UMLS CUI [3])
C3897139 (UMLS CUI [4])
C3897144 (UMLS CUI [5])
Cardiac ejection fraction | Physical Examination
Item
cardiac ejection fraction < 30%. pretreatment assessment of ejection fraction is not necessary if immediate induction is required as long as by history and physical examination patients have </= nyha class ii disease (see inclusion #7).
boolean
C0232174 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
Communicable Disease Uncontrolled | Comorbidity Severe Life Threatening | Comorbidity Severe Study Subject Participation Status Inappropriate
Item
active and uncontrolled infection or any other severe concurrent disease considered life-threatening, or which, in the judgement of the investigator and after discussion with the principal investigator, would make the patient inappropriate for entry into the study.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2826244 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1548788 (UMLS CUI [3,4])
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