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])
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])