ID

13754

Beskrivning

Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01149408

Länk

https://clinicaltrials.gov/show/NCT01149408

Nyckelord

Versioner (1)
  1. 2016-03-03 2016-03-03 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

3 mars 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01149408

Engelsk

Eligibility Acute Myeloid Leukemia NCT01149408

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with aml (excluding acute promyelocytic leukemia) according to the who classification, including de novo and secondary aml. patient must be in complete remission after 1 cycle of induction therapy consisting of cytarabine (100 mg/m2 as a 24 hour infusion for 7 consecutive days) and idarubicin (12 mg/m2 as a slow intravenous push daily for 3 days), and 2 cycles of consolidation therapy (each consisting of cytarabine at a dose of 1 g/m2 given intravenously over 3 hours every 12 hours on days 1,3,and 5).
Beskrivning

1. patients with aml (excluding acute promyelocytic leukemia) according to the who classification, including de novo and secondary aml. patient must be in complete remission after 1 cycle of induction therapy consisting of cytarabine (100 mg/m2 as a 24 hour infusion for 7 consecutive days) and idarubicin (12 mg/m2 as a slow intravenous push daily for 3 days), and 2 cycles of consolidation therapy (each consisting of cytarabine at a dose of 1 g/m2 given intravenously over 3 hours every 12 hours on days 1,3,and 5).

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0677874
UMLS CUI [2,1]
C0280449
UMLS CUI [2,2]
C0677874
UMLS CUI [3]
C0023487
UMLS CUI [4]
C0010711
UMLS CUI [5]
C0020789
2. patients who maintain morphologic complete remission as documented by a bone marrow aspirate/biopsy after consolidation therapy will be eligible to receive decitabine maintenance therapy. maintenance therapy should be started as soon as feasible after recovery from the last consolidation cycle but no sooner than 29 days after start of the last consolidation cycle and no later than 60 days after recovery from the last cycle of consolidation therapy.
Beskrivning

2. patients who maintain morphologic complete remission as documented by a bone marrow aspirate/biopsy after consolidation therapy will be eligible to receive decitabine maintenance therapy. maintenance therapy should be started as soon as feasible after recovery from the last consolidation cycle but no sooner than 29 days after start of the last consolidation cycle and no later than 60 days after recovery from the last cycle of consolidation therapy.

Datatyp

boolean

Alias
UMLS CUI [1]
C0049065
UMLS CUI [2]
C0677874
3. age ≥ 60 years
Beskrivning

3. age ≥ 60 years

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. eastern cooperative oncology group (ecog) performance status 0-1
Beskrivning

4. eastern cooperative oncology group (ecog) performance status 0-1

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. informed consent, personally signed and dated to participate in the study
Beskrivning

5. informed consent, personally signed and dated to participate in the study

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. be able to comply with study procedures and follow-up examinations
Beskrivning

6. be able to comply with study procedures and follow-up examinations

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
7. be non-fertile or agree to use birth control during the study through the end of last treatment visit
Beskrivning

7. be non-fertile or agree to use birth control during the study through the end of last treatment visit

Datatyp

boolean

Alias
UMLS CUI [1]
C0021359
UMLS CUI [2]
C0700589
8. adequate renal and hepatic function as indicated by all of the following: total bilirubin ≤ 1.5 institutional upper limit of normal (uln); and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 uln; and serum creatinine ≤ 1.5 mg/dl
Beskrivning

8. adequate renal and hepatic function as indicated by all of the following: total bilirubin ≤ 1.5 institutional upper limit of normal (uln); and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 uln; and serum creatinine ≤ 1.5 mg/dl

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
9. adequate cardiac function as measured by at least 1 of the following: left ventricular ejection fraction (lvef) ≥ 50% on multigated acquisition (muga) scan, similar radionuclide angiographic scan, or echocardiogram
Beskrivning

9. adequate cardiac function as measured by at least 1 of the following: left ventricular ejection fraction (lvef) ≥ 50% on multigated acquisition (muga) scan, similar radionuclide angiographic scan, or echocardiogram

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. diagnosis of acute promyelocytic leukemia (apl, who classification of apl with t(15;17)(q22;q12)
Beskrivning

1. diagnosis of acute promyelocytic leukemia (apl, who classification of apl with t(15;17)(q22;q12)

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
2. prior diagnosis and treatment for aml, including hematopoietic stem cell transplant (hsct)
Beskrivning

2. prior diagnosis and treatment for aml, including hematopoietic stem cell transplant (hsct)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C0472699
UMLS CUI [2,2]
C1514463
3. previous therapy with a hypomethylating agent including decitabine or azacitidine (i.e. for an antecedent myelodysplastic syndrome)
Beskrivning

3. previous therapy with a hypomethylating agent including decitabine or azacitidine (i.e. for an antecedent myelodysplastic syndrome)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2613367
UMLS CUI [1,2]
C0013227
4. any prior therapy for aml except for hydroxyurea for the control of blood counts
Beskrivning

4. any prior therapy for aml except for hydroxyurea for the control of blood counts

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1514463
UMLS CUI [2]
C0020402
5. psychiatric disorders that would interfere with consent, study participation, or follow-up
Beskrivning

5. psychiatric disorders that would interfere with consent, study participation, or follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
6. cardiac disease: heart failure nyha class 3 or 4; unstable coronary artery disease (mi more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Beskrivning

6. cardiac disease: heart failure nyha class 3 or 4; unstable coronary artery disease (mi more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0010068
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0085612
UMLS CUI [4]
C1979623
UMLS CUI [5,1]
C0027051
UMLS CUI [5,2]
C0011008
UMLS CUI [6]
C0001645
UMLS CUI [7]
C0012265
7. chronically impaired renal function (creatinine clearance < 30 ml / min)
Beskrivning

7. chronically impaired renal function (creatinine clearance < 30 ml / min)

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
8. inadequate liver function (alt and ast ≥ 2.5 x uln) if not caused by leukemic infiltration
Beskrivning

8. inadequate liver function (alt and ast ≥ 2.5 x uln) if not caused by leukemic infiltration

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
9. total bilirubin ≥ 1.5 x uln if not caused by leukemic infiltration
Beskrivning

9. total bilirubin ≥ 1.5 x uln if not caused by leukemic infiltration

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
10. known hiv and/or hepatitis c infection
Beskrivning

10. known hiv and/or hepatitis c infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019196
11. evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
Beskrivning

11. evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0005779
12. evidence or recent history of cns disease, including primary or metastatic brain tumors, seizure disorders
Beskrivning

12. evidence or recent history of cns disease, including primary or metastatic brain tumors, seizure disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
13. clinical evidence suggestive of central nervous system (cns) involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (csf)
Beskrivning

13. clinical evidence suggestive of central nervous system (cns) involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (csf)

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
UMLS CUI [2,1]
C0368761
UMLS CUI [2,2]
C0007806
14. any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo therapy on this protocol
Beskrivning

14. any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo therapy on this protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
15. systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Beskrivning

15. systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
16. diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (psa) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
Beskrivning

16. diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (psa) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007099
UMLS CUI [3]
C0699893
UMLS CUI [4]
C0206708
UMLS CUI [5]
C0600139
17. history of organ allograft
Beskrivning

17. history of organ allograft

Datatyp

boolean

Alias
UMLS CUI [1]
C0178784
18. any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
Beskrivning

18. any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
19. patients who have an indication for and can undergo a non-myeloablative transplant procedure
Beskrivning

19. patients who have an indication for and can undergo a non-myeloablative transplant procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1831742
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Similar models

Eligibility Acute Myeloid Leukemia NCT01149408

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
1. patients with aml (excluding acute promyelocytic leukemia) according to the who classification, including de novo and secondary aml. patient must be in complete remission after 1 cycle of induction therapy consisting of cytarabine (100 mg/m2 as a 24 hour infusion for 7 consecutive days) and idarubicin (12 mg/m2 as a slow intravenous push daily for 3 days), and 2 cycles of consolidation therapy (each consisting of cytarabine at a dose of 1 g/m2 given intravenously over 3 hours every 12 hours on days 1,3,and 5).
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0677874 (UMLS CUI [1,3])
C0280449 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C0023487 (UMLS CUI [3])
C0010711 (UMLS CUI [4])
C0020789 (UMLS CUI [5])
Decitabine maintenance therapy
Item
2. patients who maintain morphologic complete remission as documented by a bone marrow aspirate/biopsy after consolidation therapy will be eligible to receive decitabine maintenance therapy. maintenance therapy should be started as soon as feasible after recovery from the last consolidation cycle but no sooner than 29 days after start of the last consolidation cycle and no later than 60 days after recovery from the last cycle of consolidation therapy.
boolean
C0049065 (UMLS CUI [1])
C0677874 (UMLS CUI [2])
age
Item
3. age ≥ 60 years
boolean
C0001779 (UMLS CUI [1])
ECOG
Item
4. eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
informed consent
Item
5. informed consent, personally signed and dated to participate in the study
boolean
C0021430 (UMLS CUI [1])
compliance
Item
6. be able to comply with study procedures and follow-up examinations
boolean
C1321605 (UMLS CUI [1])
non-fertility or contraception
Item
7. be non-fertile or agree to use birth control during the study through the end of last treatment visit
boolean
C0021359 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
hepatic and renal function
Item
8. adequate renal and hepatic function as indicated by all of the following: total bilirubin ≤ 1.5 institutional upper limit of normal (uln); and aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 uln; and serum creatinine ≤ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
LVEF
Item
9. adequate cardiac function as measured by at least 1 of the following: left ventricular ejection fraction (lvef) ≥ 50% on multigated acquisition (muga) scan, similar radionuclide angiographic scan, or echocardiogram
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
APL
Item
1. diagnosis of acute promyelocytic leukemia (apl, who classification of apl with t(15;17)(q22;q12)
boolean
C0023487 (UMLS CUI [1])
prior therapy for aml
Item
2. prior diagnosis and treatment for aml, including hematopoietic stem cell transplant (hsct)
boolean
C0023467 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0472699 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
hypomethylating agents
Item
3. previous therapy with a hypomethylating agent including decitabine or azacitidine (i.e. for an antecedent myelodysplastic syndrome)
boolean
C2613367 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
any prior therapy for aml except for hydroxyurea
Item
4. any prior therapy for aml except for hydroxyurea for the control of blood counts
boolean
C0023467 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0020402 (UMLS CUI [2])
psychiatric disorders that would interfere with consent, study participation, or follow-up
Item
5. psychiatric disorders that would interfere with consent, study participation, or follow-up
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
cardiac disease
Item
6. cardiac disease: heart failure nyha class 3 or 4; unstable coronary artery disease (mi more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
boolean
C1275491 (UMLS CUI [1])
C0010068 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0085612 (UMLS CUI [3])
C1979623 (UMLS CUI [4])
C0027051 (UMLS CUI [5,1])
C0011008 (UMLS CUI [5,2])
C0001645 (UMLS CUI [6])
C0012265 (UMLS CUI [7])
creatinine clearance
Item
7. chronically impaired renal function (creatinine clearance < 30 ml / min)
boolean
C0373595 (UMLS CUI [1])
ALT and AST
Item
8. inadequate liver function (alt and ast ≥ 2.5 x uln) if not caused by leukemic infiltration
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
bilirubin
Item
9. total bilirubin ≥ 1.5 x uln if not caused by leukemic infiltration
boolean
C1278039 (UMLS CUI [1])
hiv and/or hepatitis c
Item
10. known hiv and/or hepatitis c infection
boolean
C0019682 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
bleeding diathesis or coagulopathy
Item
11. evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
boolean
C0005779 (UMLS CUI [1])
cns disease
Item
12. evidence or recent history of cns disease, including primary or metastatic brain tumors, seizure disorders
boolean
C0007682 (UMLS CUI [1])
cns leukemia
Item
13. clinical evidence suggestive of central nervous system (cns) involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (csf)
boolean
C1332884 (UMLS CUI [1])
C0368761 (UMLS CUI [2,1])
C0007806 (UMLS CUI [2,2])
comorbidity limiting study protocol
Item
14. any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo therapy on this protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
systemic infection
Item
15. systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
boolean
C0009450 (UMLS CUI [1])
malignancy
Item
16. diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (psa) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
boolean
C0006826 (UMLS CUI [1])
C0007099 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
C0206708 (UMLS CUI [4])
C0600139 (UMLS CUI [5])
organ allograft
Item
17. history of organ allograft
boolean
C0178784 (UMLS CUI [1])
condition limiting study protocol
Item
18. any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
non-myeloablative transplant procedure
Item
19. patients who have an indication for and can undergo a non-myeloablative transplant procedure
boolean
C1831742 (UMLS CUI [1])
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