ID

15378

Beskrivning

Study of Ruxolitinib Plus Decitabine in Patients With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT02257138

Länk

https://clinicaltrials.gov/show/NCT02257138

Nyckelord

Versioner (1)
  1. 2016-05-28 2016-05-28 -
Uppladdad den

28 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT02257138

Engelsk

Eligibility Leukemia NCT02257138

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02257138
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of aml (who classification definition of > or = to 20% blasts)
Beskrivning

Leukemia, Myelocytic, Acute | WHO tumor classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C1301142
2. in the phase i portion of the study all patients with relapsed or refractory aml are eligible. for the phase ii portion of the study, patients must have aml progressing from prior mpn (mpn-bp) or have mds/mpn with more than 20% blasts. temporary prior measures to control blood counts, such as apheresis or hydrea are allowed. patients with newly diagnosed or previously treated disease are eligible as long as prior therapy does not include hypomethylating agents. prior therapy for ruxolitinib for mpn is allowed.
Beskrivning

recurrent adult acute myeloid leukemia | Leukemia, Myelocytic, Acute Unresponsive to Treatment | Leukemia, Myelocytic, Acute Progressive | Myeloproliferative disease | Myeloproliferative disease Blast Phase | MYELODYSPLASTIC SYNDROME | Apheresis | Hydrea | ruxolitinib

Datatyp

boolean

Alias
UMLS CUI [1]
C0278780
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C0205329
UMLS CUI [4]
C0027022
UMLS CUI [5,1]
C0027022
UMLS CUI [5,2]
C0005699
UMLS CUI [6]
C3463824
UMLS CUI [7]
C0005791
UMLS CUI [8]
C0591617
UMLS CUI [9]
C4054751
UMLS CUI [10]
C2931926
3. serum biochemical values with the following limits unless considered due to leukemia:--- creatinine < or= to 1.5mg/dl ---- total bilirubin < or = to 1.5 mg/dl, unless increase is due to hemolysis or congenital disorder ---- transaminases (sg pt) < or = to 2.5x uln
Beskrivning

leukemia | Creatinine measurement | Bilirubin, total measurement | Hemolysis | Congenital Disorders | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0023418
UMLS CUI [2]
C0201975
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0019054
UMLS CUI [5]
C0242354
UMLS CUI [6]
C0201836
4. ability to take oral medication.
Beskrivning

Able to swallow oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
5. ability to understand and provide signed informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. performance status < or = to 3, unless directly related to disease process as determined by the principal investigator.
Beskrivning

performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
7. age > or = 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results including uncontrolled severe infections, as well as uncontrolled cardiac disease, or other organ dysfunction. patients with history of tuberculosis, hiv or hepatitis b and c are excluded.
Beskrivning

Comorbidity Interferes with Study Protocol | Recurrent infections Uncontrolled | Heart Diseases Uncontrolled | Organ dysfunction syndrome | Tuberculosis | HIV | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0239998
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0342953
UMLS CUI [5]
C0041296
UMLS CUI [6]
C0019682
UMLS CUI [7]
C0019163
UMLS CUI [8]
C0019196
2. nursing women, women of childbearing potential with positive blood pregnancy test within 30 days of study start, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, iud, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
Beskrivning

Breast Feeding | Childbearing Potential Pregnant - blood test confirms | Childbearing Potential Contraceptive methods Unwilling | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Sexual Abstinence | Condom Partner in relationship

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0425986
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0009653
UMLS CUI [8,2]
C0682323
3. incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access.
Beskrivning

history of prior surgery | Recovery Incomplete | Vascular Access Device Placement

Datatyp

boolean

Alias
UMLS CUI [1]
C0744961
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0205257
UMLS CUI [3]
C1519955
4. active clinically serious and uncontrolled infection.
Beskrivning

Communicable Diseases Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
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Similar models

Eligibility Leukemia NCT02257138

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02257138
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute | WHO tumor classification
Item
1. diagnosis of aml (who classification definition of > or = to 20% blasts)
boolean
C0023467 (UMLS CUI [1])
C1301142 (UMLS CUI [2])
recurrent adult acute myeloid leukemia | Leukemia, Myelocytic, Acute Unresponsive to Treatment | Leukemia, Myelocytic, Acute Progressive | Myeloproliferative disease | Myeloproliferative disease Blast Phase | MYELODYSPLASTIC SYNDROME | Apheresis | Hydrea | ruxolitinib
Item
2. in the phase i portion of the study all patients with relapsed or refractory aml are eligible. for the phase ii portion of the study, patients must have aml progressing from prior mpn (mpn-bp) or have mds/mpn with more than 20% blasts. temporary prior measures to control blood counts, such as apheresis or hydrea are allowed. patients with newly diagnosed or previously treated disease are eligible as long as prior therapy does not include hypomethylating agents. prior therapy for ruxolitinib for mpn is allowed.
boolean
C0278780 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0023467 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
C0027022 (UMLS CUI [4])
C0027022 (UMLS CUI [5,1])
C0005699 (UMLS CUI [5,2])
C3463824 (UMLS CUI [6])
C0005791 (UMLS CUI [7])
C0591617 (UMLS CUI [8])
C4054751 (UMLS CUI [9])
C2931926 (UMLS CUI [10])
leukemia | Creatinine measurement | Bilirubin, total measurement | Hemolysis | Congenital Disorders | Alanine aminotransferase measurement
Item
3. serum biochemical values with the following limits unless considered due to leukemia:--- creatinine < or= to 1.5mg/dl ---- total bilirubin < or = to 1.5 mg/dl, unless increase is due to hemolysis or congenital disorder ---- transaminases (sg pt) < or = to 2.5x uln
boolean
C0023418 (UMLS CUI [1])
C0201975 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0019054 (UMLS CUI [4])
C0242354 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
Able to swallow oral medication
Item
4. ability to take oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Informed Consent
Item
5. ability to understand and provide signed informed consent.
boolean
C0021430 (UMLS CUI [1])
performance status
Item
6. performance status < or = to 3, unless directly related to disease process as determined by the principal investigator.
boolean
C1518965 (UMLS CUI [1])
Age
Item
7. age > or = 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Comorbidity Interferes with Study Protocol | Recurrent infections Uncontrolled | Heart Diseases Uncontrolled | Organ dysfunction syndrome | Tuberculosis | HIV | Hepatitis B | Hepatitis C
Item
1. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results including uncontrolled severe infections, as well as uncontrolled cardiac disease, or other organ dysfunction. patients with history of tuberculosis, hiv or hepatitis b and c are excluded.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0239998 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0342953 (UMLS CUI [4])
C0041296 (UMLS CUI [5])
C0019682 (UMLS CUI [6])
C0019163 (UMLS CUI [7])
C0019196 (UMLS CUI [8])
Breast Feeding | Childbearing Potential Pregnant - blood test confirms | Childbearing Potential Contraceptive methods Unwilling | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Sexual Abstinence | Condom Partner in relationship
Item
2. nursing women, women of childbearing potential with positive blood pregnancy test within 30 days of study start, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, iud, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
boolean
C0006147 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0425986 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0009653 (UMLS CUI [8,1])
C0682323 (UMLS CUI [8,2])
history of prior surgery | Recovery Incomplete | Vascular Access Device Placement
Item
3. incomplete recovery from any prior surgical procedures or had surgery within 4 weeks prior to study entry, excluding the placement of vascular access.
boolean
C0744961 (UMLS CUI [1])
C2004454 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C1519955 (UMLS CUI [3])
Communicable Diseases Serious Uncontrolled
Item
4. active clinically serious and uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
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