ID

41094

Description

Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01786343

Link

https://clinicaltrials.gov/show/NCT01786343

Keywords

Versions (1)
  1. 6/23/20 6/23/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 23, 2020

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01786343

English

Eligibility Leukemia NCT01786343

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01786343
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with previously untreated aml (by the who criteria, i.e. >/= 20% blasts) prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine. patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment.
Description

AML Untreated | Blasts Percentage | Biological treatment MYELODYSPLASTIC SYNDROME | Growth Factor | Targeted Therapy MYELODYSPLASTIC SYNDROME | Exception Hypomethylation Therapy | Exception Azacitidine | Exception Decitabine | Therapeutic procedure Discontinued | Toxicity Due to Therapeutic procedure | Patient recovered | Exception Rapid disease progression | Hydroxyurea allowed | Cytarabine Dose allowed

Data type

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]
C1531518
UMLS CUI [3,2]
C3463824
UMLS CUI [4]
C0018284
UMLS CUI [5,1]
C2985566
UMLS CUI [5,2]
C3463824
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C4054751
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0004475
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0049065
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C1444662
UMLS CUI [10,1]
C0600688
UMLS CUI [10,2]
C0678226
UMLS CUI [10,3]
C0087111
UMLS CUI [11]
C1115804
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C1834700
UMLS CUI [13,1]
C0020402
UMLS CUI [13,2]
C0683607
UMLS CUI [14,1]
C0010711
UMLS CUI [14,2]
C0178602
UMLS CUI [14,3]
C0683607
2. patients >/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by kantarjian's score (appendix d) patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. performance 0-3 (ecog).
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. adequate liver function (total bilirubin of < 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or gilbert's syndrome and renal function (creatinine < 2.5 mg/dl).
Description

Liver function | Serum total bilirubin measurement | Exception Due to Hemolysis | Exception Due to Leukemia | Exception Due to Gilbert Disease | Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0019054
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0023418
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0017551
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
5. 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. female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. negative urine pregnancy test (women of childbearing potential)
Description

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430057
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, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cancer Other Requirement Chemotherapy | Cancer Other Requirement Therapeutic radiology procedure | Exception Skin carcinoma | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C1707251
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0392920
UMLS CUI [5,1]
C1707251
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C1522449
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0699893
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
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Similar models

Eligibility Leukemia NCT01786343

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01786343
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML Untreated | Blasts Percentage | Biological treatment MYELODYSPLASTIC SYNDROME | Growth Factor | Targeted Therapy MYELODYSPLASTIC SYNDROME | Exception Hypomethylation Therapy | Exception Azacitidine | Exception Decitabine | Therapeutic procedure Discontinued | Toxicity Due to Therapeutic procedure | Patient recovered | Exception Rapid disease progression | Hydroxyurea allowed | Cytarabine Dose allowed
Item
1. patients with previously untreated aml (by the who criteria, i.e. >/= 20% blasts) prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine. patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0368761 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C0018284 (UMLS CUI [4])
C2985566 (UMLS CUI [5,1])
C3463824 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C4054751 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0004475 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0049065 (UMLS CUI [8,2])
C0087111 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
C0600688 (UMLS CUI [10,1])
C0678226 (UMLS CUI [10,2])
C0087111 (UMLS CUI [10,3])
C1115804 (UMLS CUI [11])
C1705847 (UMLS CUI [12,1])
C1834700 (UMLS CUI [12,2])
C0020402 (UMLS CUI [13,1])
C0683607 (UMLS CUI [13,2])
C0010711 (UMLS CUI [14,1])
C0178602 (UMLS CUI [14,2])
C0683607 (UMLS CUI [14,3])
Age
Item
2. patients >/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by kantarjian's score (appendix d) patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. performance 0-3 (ecog).
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Exception Due to Hemolysis | Exception Due to Leukemia | Exception Due to Gilbert Disease | Renal function | Creatinine measurement, serum
Item
4. adequate liver function (total bilirubin of < 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or gilbert's syndrome and renal function (creatinine < 2.5 mg/dl).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0019054 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0023418 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0017551 (UMLS CUI [5,3])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Informed Consent
Item
5. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative
Item
1. nursing and pregnant females. female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. negative urine pregnancy test (women of childbearing potential)
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
Communicable Disease Uncontrolled
Item
2. active and uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cancer Other Requirement Chemotherapy | Cancer Other Requirement Therapeutic radiology procedure | Exception Skin carcinoma | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
3. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C1707251 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
C1707251 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0699893 (UMLS CUI [6,2])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
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