ID

22021

Description

Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00414310

Link

https://clinicaltrials.gov/show/NCT00414310

Keywords

Versions (1)
  1. 5/15/17 5/15/17 -
Uploaded on

May 15, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Myelodysplastic Syndrome NCT00414310

English

Eligibility Myelodysplastic Syndrome NCT00414310

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with mds and > 5% blasts or ipss risk intermediate or high; patients with cmml; patients with aml who are age 60 or older. no prior intensive chemotherapy or high-dose ara-c (> 1g/m2). no prior azacytidine for 3 cycles or more or prior decitabine for 2 cycles or more. prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
Description

MYELODYSPLASTIC SYNDROME | Blast Cell Percentage | Intermediate Risk IPSS | High risk IPSS | Leukemia, Myelomonocytic, Chronic | Leukemia, Myelocytic, Acute | Age | Chemotherapy With intensity | Ara-C High dose | Azacitidine Therapeutic procedure Quantity | decitabine Therapeutic procedure Quantity | Biological treatment | Targeted Therapy | Chemotherapy, single agent | Chemotherapy Discontinued | Toxic effect Patient recovered | Rapidly progressive disorder Evidence of

Data type

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2,1]
C0368761
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C3640764
UMLS CUI [3,2]
C2827405
UMLS CUI [4,1]
C0332167
UMLS CUI [4,2]
C2827405
UMLS CUI [5]
C0023480
UMLS CUI [6]
C0023467
UMLS CUI [7]
C0001779
UMLS CUI [8,1]
C0392920
UMLS CUI [8,2]
C0522510
UMLS CUI [9,1]
C0733521
UMLS CUI [9,2]
C0444956
UMLS CUI [10,1]
C0004475
UMLS CUI [10,2]
C0087111
UMLS CUI [10,3]
C1265611
UMLS CUI [11,1]
C0049065
UMLS CUI [11,2]
C0087111
UMLS CUI [11,3]
C1265611
UMLS CUI [12]
C1531518
UMLS CUI [13]
C2985566
UMLS CUI [14]
C3846440
UMLS CUI [15,1]
C0392920
UMLS CUI [15,2]
C1444662
UMLS CUI [16,1]
C0600688
UMLS CUI [16,2]
C1115804
UMLS CUI [17,1]
C1850776
UMLS CUI [17,2]
C0332120
2. continued from #1: hydroxyurea is permitted for control of counts prior to treatment. procrit, granulocyte colony-stimulating factor (gcsf) are allowed before therapy. procrit, gcsf or other growth factors are permitted on therapy. use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy.
Description

hydroxyurea | Procrit | Granulocyte Colony-Stimulating Factor | Growth Factor | Disease Proliferative Rapidly

Data type

boolean

Alias
UMLS CUI [1]
C0020402
UMLS CUI [2]
C0733467
UMLS CUI [3]
C0079459
UMLS CUI [4]
C0018284
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0334094
UMLS CUI [5,3]
C0456962
3. performance 0-2 (ecog). adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). adequate cardiac functions (nyha cardiac iii-iv excluded). alt < 2.5x institutional upper limit of normal.
Description

ECOG performance status | Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Cardiac function | Heart Disease New York Heart Association Classification | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0232741
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0232804
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0232164
UMLS CUI [7,1]
C0018799
UMLS CUI [7,2]
C1275491
UMLS CUI [8]
C0201836
4. signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nursing and pregnant females. patients of childbearing potential should practice effective methods of contraception. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
2. active and uncontrolled infections.
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
3. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Mental disorder Protocol Compliance Limited | social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C0439801
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
4. known ornithine transcarbamylase disorder.
Description

Ornithine carbamoyltransferase deficiency

Data type

boolean

Alias
UMLS CUI [1]
C0268542
5. patients requiring continuous valproic acid treatment for the control of seizure disorders.
Description

Valproic Acid Patient need for | Epilepsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0042291
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C0014544
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Similar models

Eligibility Myelodysplastic Syndrome NCT00414310

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
MYELODYSPLASTIC SYNDROME | Blast Cell Percentage | Intermediate Risk IPSS | High risk IPSS | Leukemia, Myelomonocytic, Chronic | Leukemia, Myelocytic, Acute | Age | Chemotherapy With intensity | Ara-C High dose | Azacitidine Therapeutic procedure Quantity | decitabine Therapeutic procedure Quantity | Biological treatment | Targeted Therapy | Chemotherapy, single agent | Chemotherapy Discontinued | Toxic effect Patient recovered | Rapidly progressive disorder Evidence of
Item
1. patients with mds and > 5% blasts or ipss risk intermediate or high; patients with cmml; patients with aml who are age 60 or older. no prior intensive chemotherapy or high-dose ara-c (> 1g/m2). no prior azacytidine for 3 cycles or more or prior decitabine for 2 cycles or more. prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
boolean
C3463824 (UMLS CUI [1])
C0368761 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C3640764 (UMLS CUI [3,1])
C2827405 (UMLS CUI [3,2])
C0332167 (UMLS CUI [4,1])
C2827405 (UMLS CUI [4,2])
C0023480 (UMLS CUI [5])
C0023467 (UMLS CUI [6])
C0001779 (UMLS CUI [7])
C0392920 (UMLS CUI [8,1])
C0522510 (UMLS CUI [8,2])
C0733521 (UMLS CUI [9,1])
C0444956 (UMLS CUI [9,2])
C0004475 (UMLS CUI [10,1])
C0087111 (UMLS CUI [10,2])
C1265611 (UMLS CUI [10,3])
C0049065 (UMLS CUI [11,1])
C0087111 (UMLS CUI [11,2])
C1265611 (UMLS CUI [11,3])
C1531518 (UMLS CUI [12])
C2985566 (UMLS CUI [13])
C3846440 (UMLS CUI [14])
C0392920 (UMLS CUI [15,1])
C1444662 (UMLS CUI [15,2])
C0600688 (UMLS CUI [16,1])
C1115804 (UMLS CUI [16,2])
C1850776 (UMLS CUI [17,1])
C0332120 (UMLS CUI [17,2])
hydroxyurea | Procrit | Granulocyte Colony-Stimulating Factor | Growth Factor | Disease Proliferative Rapidly
Item
2. continued from #1: hydroxyurea is permitted for control of counts prior to treatment. procrit, granulocyte colony-stimulating factor (gcsf) are allowed before therapy. procrit, gcsf or other growth factors are permitted on therapy. use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy.
boolean
C0020402 (UMLS CUI [1])
C0733467 (UMLS CUI [2])
C0079459 (UMLS CUI [3])
C0018284 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0334094 (UMLS CUI [5,2])
C0456962 (UMLS CUI [5,3])
ECOG performance status | Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Cardiac function | Heart Disease New York Heart Association Classification | Alanine aminotransferase measurement
Item
3. performance 0-2 (ecog). adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). adequate cardiac functions (nyha cardiac iii-iv excluded). alt < 2.5x institutional upper limit of normal.
boolean
C1520224 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0232164 (UMLS CUI [6])
C0018799 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
C0201836 (UMLS CUI [8])
Informed Consent
Item
4. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods
Item
1. nursing and pregnant females. patients of childbearing potential should practice effective methods of contraception. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Communicable Disease Uncontrolled
Item
2. active and uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Mental disorder Protocol Compliance Limited | social situation Protocol Compliance Limited
Item
3. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
Ornithine carbamoyltransferase deficiency
Item
4. known ornithine transcarbamylase disorder.
boolean
C0268542 (UMLS CUI [1])
Valproic Acid Patient need for | Epilepsy
Item
5. patients requiring continuous valproic acid treatment for the control of seizure disorders.
boolean
C0042291 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2])
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