ID

17837

Description

Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes; ODM derived from: https://clinicaltrials.gov/show/NCT00075010

Link

https://clinicaltrials.gov/show/NCT00075010

Keywords

Versions (1)
  1. 10/4/16 10/4/16 -
Uploaded on

October 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00075010

English

Eligibility Leukemia NCT00075010

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00075010
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. for phase i component of the study: patients with refractory or relapsed: acute myelogenous leukemia (aml), acute lymphocytic leukemia (all), and myelodysplastic syndrome (mds) are eligible. patients with chronic lymphocytic leukemia (cll) are eligible if fludarabine based therapy has failed. patients with chronic myeloid leukemia (cml) are eligible if they have documented hematologic resistance to imatinib mesylate or have not achieved or lost any cytogenetic response to imatinib mesylate after 12 months of therapy.
Description

Acute Myelocytic Leukemia refractory | Acute Myelocytic Leukemia Relapsed | Acute lymphocytic leukaemia refractory | Acute lymphocytic leukemia Relapsed | MYELODYSPLASTIC SYNDROME refractory | MYELODYSPLASTIC SYNDROME Relapsed | Chronic Lymphocytic Leukemia | fludarabine failed | Myeloid Leukemia, Chronic | Resistance Hematologic Imatinib mesylate | Cytogenetic No Response Imatinib mesylate

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0205336
UMLS CUI [3]
C4049242
UMLS CUI [4,1]
C0023449
UMLS CUI [4,2]
C0205336
UMLS CUI [5,1]
C3463824
UMLS CUI [5,2]
C0205269
UMLS CUI [6,1]
C3463824
UMLS CUI [6,2]
C0205336
UMLS CUI [7]
C0023434
UMLS CUI [8,1]
C0059985
UMLS CUI [8,2]
C0231175
UMLS CUI [9]
C0023473
UMLS CUI [10,1]
C1514892
UMLS CUI [10,2]
C0205488
UMLS CUI [10,3]
C0939537
UMLS CUI [11,1]
C4055170
UMLS CUI [11,2]
C0939537
2. untreated patients older than 60 years of age with aml or mds who refuse or are not eligible for frontline chemotherapy, are eligible.
Description

Patients untreated | Age | Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME | Chemotherapy Primary Refused | Chemotherapy Primary Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0023467
UMLS CUI [4]
C3463824
UMLS CUI [5,1]
C3665472
UMLS CUI [5,2]
C0205225
UMLS CUI [5,3]
C1705116
UMLS CUI [6,1]
C3665472
UMLS CUI [6,2]
C0205225
UMLS CUI [6,3]
C1512714
3. performance status of =/< 2 by the ecog scale.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of utmdacc.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
5. age > 2 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
6. 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. use of hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy. imatinib mesylate (gleevec) and anagrelide must also be stopped 2 weeks prior to entering this study.
Description

Chemotherapy To be stopped | Toxic effect Due to Chemotherapy | Patient Recovered | Rapidly progressive disorder Evidence of | hydroxyurea | Disease Proliferative Rapid | Imatinib mesylate | Gleevec | anagrelide

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C1272691
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C3665472
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0521108
UMLS CUI [4,1]
C1850776
UMLS CUI [4,2]
C0332120
UMLS CUI [5]
C0020402
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0334094
UMLS CUI [6,3]
C0456962
UMLS CUI [7]
C0939537
UMLS CUI [8]
C0935987
UMLS CUI [9]
C0051809
7. adequate liver function (bilirubin of < 2mg%, sgpt < 3 x uln) and renal function (creatinine < 2mg%).
Description

Liver function | Serum total bilirubin measurement | Alanine 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]
C0232804
UMLS CUI [5]
C0201976
8. women of childbearing potential must practice contraception. men and women must continue birth control for the duration of the trial.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
9. inclusion of phase ii portion of the study: as in the phase i portion but only patients with aml or high-risk mds (blasts > or = 10%), including untreated patients older than 60 years of age with aml or mds who refuse or are not eligible for frontline chemotherapy, will be eligible in this portion of the study.
Description

Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME High risk of | Blast count procedure | Patients untreated | Age | Chemotherapy Primary Refused | Chemotherapy Primary Ineligible

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0332167
UMLS CUI [3]
C0523113
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0332155
UMLS CUI [5]
C0001779
UMLS CUI [6,1]
C3665472
UMLS CUI [6,2]
C0205225
UMLS CUI [6,3]
C1705116
UMLS CUI [7,1]
C3665472
UMLS CUI [7,2]
C0205225
UMLS CUI [7,3]
C1512714
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nursing and pregnant females are excluded.
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
2. patients with active and uncontrolled infections are excluded.
Description

Communicable Diseases | Communicable Diseases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
3. patients with a known ornithine transcarbamylase disorder, history of unexplained coma or a family history of ornithine transcarbamylase disorder are excluded from this study.
Description

Ornithine carbamoyltransferase deficiency | Coma Cause Unknown | Ornithine carbamoyltransferase deficiency Family history

Data type

boolean

Alias
UMLS CUI [1]
C0268542
UMLS CUI [2,1]
C0009421
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0439673
UMLS CUI [3,1]
C0268542
UMLS CUI [3,2]
C0241889
4. uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, pancreatitis, psychiatric illness that would limit compliance with study requirements.
Description

Illness Uncontrolled Protocol Compliance Limited | Symptomatic congestive heart failure | Angina, Unstable | Pancreatitis | Mental disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C0439801
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0030305
UMLS CUI [5]
C0004936
5. patients with history of hepatitis b, c, alcoholic liver disease or evidence of hepatopathy will be excluded.
Description

Hepatitis B | Hepatitis C | Alcoholic Liver Diseases | Liver disease Evidence of

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0023896
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0332120
6. patients already receiving valproic acid or receiving other anticonvulsivants will be excluded.
Description

Valproic Acid | Anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0042291
UMLS CUI [2]
C0003286
7. untreated patients younger than 60 years will not be candidates for this study.
Description

Age | Patients untreated

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
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Similar models

Eligibility Leukemia NCT00075010

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00075010
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute Myelocytic Leukemia refractory | Acute Myelocytic Leukemia Relapsed | Acute lymphocytic leukaemia refractory | Acute lymphocytic leukemia Relapsed | MYELODYSPLASTIC SYNDROME refractory | MYELODYSPLASTIC SYNDROME Relapsed | Chronic Lymphocytic Leukemia | fludarabine failed | Myeloid Leukemia, Chronic | Resistance Hematologic Imatinib mesylate | Cytogenetic No Response Imatinib mesylate
Item
1. for phase i component of the study: patients with refractory or relapsed: acute myelogenous leukemia (aml), acute lymphocytic leukemia (all), and myelodysplastic syndrome (mds) are eligible. patients with chronic lymphocytic leukemia (cll) are eligible if fludarabine based therapy has failed. patients with chronic myeloid leukemia (cml) are eligible if they have documented hematologic resistance to imatinib mesylate or have not achieved or lost any cytogenetic response to imatinib mesylate after 12 months of therapy.
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0205336 (UMLS CUI [2,2])
C4049242 (UMLS CUI [3])
C0023449 (UMLS CUI [4,1])
C0205336 (UMLS CUI [4,2])
C3463824 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
C3463824 (UMLS CUI [6,1])
C0205336 (UMLS CUI [6,2])
C0023434 (UMLS CUI [7])
C0059985 (UMLS CUI [8,1])
C0231175 (UMLS CUI [8,2])
C0023473 (UMLS CUI [9])
C1514892 (UMLS CUI [10,1])
C0205488 (UMLS CUI [10,2])
C0939537 (UMLS CUI [10,3])
C4055170 (UMLS CUI [11,1])
C0939537 (UMLS CUI [11,2])
Patients untreated | Age | Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME | Chemotherapy Primary Refused | Chemotherapy Primary Ineligible
Item
2. untreated patients older than 60 years of age with aml or mds who refuse or are not eligible for frontline chemotherapy, are eligible.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
C3463824 (UMLS CUI [4])
C3665472 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C1705116 (UMLS CUI [5,3])
C3665472 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C1512714 (UMLS CUI [6,3])
ECOG performance status
Item
3. performance status of =/< 2 by the ecog scale.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
4. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of utmdacc.
boolean
C0021430 (UMLS CUI [1])
Age
Item
5. age > 2 years.
boolean
C0001779 (UMLS CUI [1])
Chemotherapy To be stopped | Toxic effect Due to Chemotherapy | Patient Recovered | Rapidly progressive disorder Evidence of | hydroxyurea | Disease Proliferative Rapid | Imatinib mesylate | Gleevec | anagrelide
Item
6. 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. use of hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy. imatinib mesylate (gleevec) and anagrelide must also be stopped 2 weeks prior to entering this study.
boolean
C3665472 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C3665472 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
C1850776 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
C0020402 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0334094 (UMLS CUI [6,2])
C0456962 (UMLS CUI [6,3])
C0939537 (UMLS CUI [7])
C0935987 (UMLS CUI [8])
C0051809 (UMLS CUI [9])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
7. adequate liver function (bilirubin of < 2mg%, sgpt < 3 x uln) and renal function (creatinine < 2mg%).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
8. women of childbearing potential must practice contraception. men and women must continue birth control for the duration of the trial.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME High risk of | Blast count procedure | Patients untreated | Age | Chemotherapy Primary Refused | Chemotherapy Primary Ineligible
Item
9. inclusion of phase ii portion of the study: as in the phase i portion but only patients with aml or high-risk mds (blasts > or = 10%), including untreated patients older than 60 years of age with aml or mds who refuse or are not eligible for frontline chemotherapy, will be eligible in this portion of the study.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0523113 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0001779 (UMLS CUI [5])
C3665472 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C1705116 (UMLS CUI [6,3])
C3665472 (UMLS CUI [7,1])
C0205225 (UMLS CUI [7,2])
C1512714 (UMLS CUI [7,3])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
1. nursing and pregnant females are excluded.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Communicable Diseases | Communicable Diseases Uncontrolled
Item
2. patients with active and uncontrolled infections are excluded.
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Ornithine carbamoyltransferase deficiency | Coma Cause Unknown | Ornithine carbamoyltransferase deficiency Family history
Item
3. patients with a known ornithine transcarbamylase disorder, history of unexplained coma or a family history of ornithine transcarbamylase disorder are excluded from this study.
boolean
C0268542 (UMLS CUI [1])
C0009421 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0439673 (UMLS CUI [2,3])
C0268542 (UMLS CUI [3,1])
C0241889 (UMLS CUI [3,2])
Illness Uncontrolled Protocol Compliance Limited | Symptomatic congestive heart failure | Angina, Unstable | Pancreatitis | Mental disorders
Item
4. uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, pancreatitis, psychiatric illness that would limit compliance with study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
Hepatitis B | Hepatitis C | Alcoholic Liver Diseases | Liver disease Evidence of
Item
5. patients with history of hepatitis b, c, alcoholic liver disease or evidence of hepatopathy will be excluded.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0023896 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
Valproic Acid | Anticonvulsants
Item
6. patients already receiving valproic acid or receiving other anticonvulsivants will be excluded.
boolean
C0042291 (UMLS CUI [1])
C0003286 (UMLS CUI [2])
Age | Patients untreated
Item
7. untreated patients younger than 60 years will not be candidates for this study.
boolean
C0001779 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
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