ID

41037

Beskrivning

Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00948064

Länk

https://clinicaltrials.gov/show/NCT00948064

Nyckelord

Versioner (1)
  1. 2020-06-16 2020-06-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT00948064

Engelsk

Eligibility Leukemia NCT00948064

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00948064
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with newly diagnosed aml or mds (intermediate 1 or higher risk)
Beskrivning

AML | MYELODYSPLASTIC SYNDROME Risk Intermediate-1

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C4528416
2. patient must have at least one of the following: a. creatinine >/= 2 mg/dl; b. total bilirubin >/= 2 mg/dl; c.ecog performance status equal to 3 or 4; and d. is ineligible for participation on a protocol of higher priority
Beskrivning

Creatinine measurement, serum | Serum total bilirubin measurement | ECOG performance status | Participation Study Protocol High priority Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C1520224
UMLS CUI [4,1]
C0679823
UMLS CUI [4,2]
C2348563
UMLS CUI [4,3]
C1273516
UMLS CUI [4,4]
C1299582
3. patients must provide written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
4. patients must be age > 18 years due to lack of safety information with these agents in children.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. patient agrees to: 1) use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method) or 2) abstain from heterosexual activity throughout the study starting with visit 1.
Beskrivning

Contraceptive methods Quantity | Barrier Contraception Quantity | Hormonal contraception | Avoidance Heterosexual activity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C2985296
UMLS CUI [4,1]
C0870186
UMLS CUI [4,2]
C4272228
6. female patients of childbearing potential should have a negative pregnancy test (serum) within 72 hrs. of study enrollment.
Beskrivning

Childbearing Potential Serum pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients must not have the favorable cytogenetic abnormalities of inv (16), t (16;16), t (8;21), or t (15;17).
Beskrivning

inv(16) Absent | t(16;16) Absent | t(8;21) Absent | t(15;17) Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3897144
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C4287945
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3897139
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C4287946
UMLS CUI [4,2]
C0332197
2. patients receiving any anti-leukemic therapy with the exception of hydroxyurea prior to study enrollment. prior growth factor therapy is acceptable. hydroxyurea could be used at the discretion of the treating physician. a single or a two day dose of cytarabine (up to 3 g/m^2) for emergency use is allowed as prior therapy.
Beskrivning

Antileukemic Agent | Exception Hydroxyurea | Growth Factor Receptors Acceptable | Cytarabine Dose allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0596112
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020402
UMLS CUI [3,1]
C0206454
UMLS CUI [3,2]
C1879533
UMLS CUI [4,1]
C0010711
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0683607
3. patient has a prior history of treatment with hdac inhibitors. patients who have received valproic acid (vpa) for the treatment of seizures may be enrolled on this study, but must not have received vpa within 30 days of study enrollment.
Beskrivning

Histone deacetylase inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C1512474
4. patient is unable to take and/or tolerate oral medications on a continuous basis, examples include patients on a ventilator, or have altered mental status that precludes safe oral route of administration.
Beskrivning

Lacking Able to swallow Oral medication | Intolerance to Oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0175795
5. patient has active hepatitis a, b, or c infection.
Beskrivning

Hepatitis A | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
6. patient is pregnant or breast-feeding.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patient has a known allergy or hypersensitivity to any component of vorinostat or azacitidine.
Beskrivning

Hypersensitivity Component Vorinostat | Hypersensitivity Component Azacitidine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0672708
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0004475
8. history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
Beskrivning

Mental condition Impairing Comprehension Study Protocol | Mental condition Impairing Protocol Compliance | Mental condition Impairing Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C0021430
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Similar models

Eligibility Leukemia NCT00948064

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00948064
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
AML | MYELODYSPLASTIC SYNDROME Risk Intermediate-1
Item
1. patients with newly diagnosed aml or mds (intermediate 1 or higher risk)
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2,1])
C4528416 (UMLS CUI [2,2])
Creatinine measurement, serum | Serum total bilirubin measurement | ECOG performance status | Participation Study Protocol High priority Unable
Item
2. patient must have at least one of the following: a. creatinine >/= 2 mg/dl; b. total bilirubin >/= 2 mg/dl; c.ecog performance status equal to 3 or 4; and d. is ineligible for participation on a protocol of higher priority
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C1520224 (UMLS CUI [3])
C0679823 (UMLS CUI [4,1])
C2348563 (UMLS CUI [4,2])
C1273516 (UMLS CUI [4,3])
C1299582 (UMLS CUI [4,4])
Informed Consent
Item
3. patients must provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
4. patients must be age > 18 years due to lack of safety information with these agents in children.
boolean
C0001779 (UMLS CUI [1])
Contraceptive methods Quantity | Barrier Contraception Quantity | Hormonal contraception | Avoidance Heterosexual activity
Item
5. patient agrees to: 1) use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method) or 2) abstain from heterosexual activity throughout the study starting with visit 1.
boolean
C0700589 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0004764 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0870186 (UMLS CUI [4,1])
C4272228 (UMLS CUI [4,2])
Childbearing Potential Serum pregnancy test negative
Item
6. female patients of childbearing potential should have a negative pregnancy test (serum) within 72 hrs. of study enrollment.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
inv(16) Absent | t(16;16) Absent | t(8;21) Absent | t(15;17) Absent
Item
1. patients must not have the favorable cytogenetic abnormalities of inv (16), t (16;16), t (8;21), or t (15;17).
boolean
C3897144 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4287945 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3897139 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C4287946 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Antileukemic Agent | Exception Hydroxyurea | Growth Factor Receptors Acceptable | Cytarabine Dose allowed
Item
2. patients receiving any anti-leukemic therapy with the exception of hydroxyurea prior to study enrollment. prior growth factor therapy is acceptable. hydroxyurea could be used at the discretion of the treating physician. a single or a two day dose of cytarabine (up to 3 g/m^2) for emergency use is allowed as prior therapy.
boolean
C0596112 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020402 (UMLS CUI [2,2])
C0206454 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
C0010711 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Histone deacetylase inhibitor
Item
3. patient has a prior history of treatment with hdac inhibitors. patients who have received valproic acid (vpa) for the treatment of seizures may be enrolled on this study, but must not have received vpa within 30 days of study enrollment.
boolean
C1512474 (UMLS CUI [1])
Lacking Able to swallow Oral medication | Intolerance to Oral medication
Item
4. patient is unable to take and/or tolerate oral medications on a continuous basis, examples include patients on a ventilator, or have altered mental status that precludes safe oral route of administration.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0175795 (UMLS CUI [2,2])
Hepatitis A | Hepatitis B | Hepatitis C
Item
5. patient has active hepatitis a, b, or c infection.
boolean
C0019159 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
6. patient is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Component Vorinostat | Hypersensitivity Component Azacitidine
Item
7. patient has a known allergy or hypersensitivity to any component of vorinostat or azacitidine.
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0672708 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0004475 (UMLS CUI [2,3])
Mental condition Impairing Comprehension Study Protocol | Mental condition Impairing Protocol Compliance | Mental condition Impairing Informed Consent
Item
8. history of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
boolean
C3840291 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
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