Adult | AML WHO tumor classification | Exception Acute Promyelocytic Leukemia | High risk MYELODYSPLASTIC SYNDROME IPSS | Patient Inappropriate Chemotherapy With intensity | Age | Comorbidity | Disease Newly Diagnosed
Item
adults with aml (except acute promyelocytic leukaemia (apl)) as defined by the world health organisation (who) classification or patients with high risk mds categorised as int-2 or high risk according to the international prognostic scoring system (ipss) who are deemed ineligible for intensive chemotherapy on the grounds of age or co-morbidities with one of the following disease status:- i) newly diagnosed or
boolean
C0001675 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C1301142 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023487 (UMLS CUI [3,2])
C4319571 (UMLS CUI [4,1])
C3463824 (UMLS CUI [4,2])
C2827405 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
C0522510 (UMLS CUI [5,4])
C0001779 (UMLS CUI [6])
C0009488 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C1518321 (UMLS CUI [8,2])
Recurrent disease | Morphologic Complete Response Previous
Item
ii) relapsed disease: patients must have achieved a previous morphological cr and show evidence of recurrent disease or
boolean
C0277556 (UMLS CUI [1])
C4054467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Refractory Disease | Morphologic Complete Response Failed
Item
iii) refractory disease: patients who have failed to achieve a morphological cr with previous therapy
boolean
C1514815 (UMLS CUI [1])
C4054467 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Ability Outpatient Treatment
Item
patients are able to receive treatment as out-patient
boolean
C0085732 (UMLS CUI [1,1])
C0029921 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Renal function | Liver function
Item
adequate renal and hepatic function as defined in the protocol
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Informed Consent
Item
patients have given written informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Impairment cardiac New York Heart Association Classification
Item
patients with greater than class iii nyha cardiac impairment
boolean
C0221099 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Blast Phase
Item
blastic transformation of chronic myeloid leukaemia
boolean
C0005699 (UMLS CUI [1])
Allogeneic hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant
Item
prior allogeneic/autologous haematopoietic stem cell transplant
boolean
C4255274 (UMLS CUI [1])
C2193200 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
adults of reproductive potential not willing to use appropriate, effective, contraception during the trial and for specified amount of time afterwards
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Histone deacetylase inhibitor | Cancer treatment
Item
patients who have received prior histone deacetylase inhibitor (hdaci) treatment as anti-tumour therapy. (patients who have received hdaci treatment for other indications e.g valproic acid for epilepsy may enrol after a 30-day washout period)
boolean
C1512474 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Cancer treatment | Investigational New Drugs | Small Molecule Against Neoplasm | Biological agents
Item
previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 30 days before the start of protocol treatment. (patients receiving anti-tumour therapies to control blood counts may enrol into the trial)
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0027651 (UMLS CUI [3,3])
C0005515 (UMLS CUI [4])
Demethylating Agent | azacitidine | decitabine
Item
patients who have received prior treatment with demethylating agents such as 5-azacitidine or decitabine
boolean
C4329713 (UMLS CUI [1])
C0004475 (UMLS CUI [2])
C0049065 (UMLS CUI [3])
Medical contraindication azacitidine | Medical contraindication vorinostat | Hypersensitivity azacitidine | Hypersensitivity vorinostat | Subcutaneous Injections Receive Unable | Lacking Able to swallow Capsule
Item
patients with contraindications to receiving azacitidine or vorinostat such as hypersensitivity, patients unable to have a subcutaneous injection or swallow oral capsules
boolean
C1301624 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0672708 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0004475 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0672708 (UMLS CUI [4,2])
C0021499 (UMLS CUI [5,1])
C1514756 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0332268 (UMLS CUI [6,1])
C2712086 (UMLS CUI [6,2])
C0006935 (UMLS CUI [6,3])
Mycoses Symptomatic | Bacterial Infections Symptomatic | Virus Diseases Symptomatic | HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C
Item
active symptomatic fungal, bacterial, and/or viral infection including known active hiv or known viral (a, b, or c) hepatitis
boolean
C0026946 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0004623 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4])
C0019159 (UMLS CUI [5])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
Comorbidity Limiting Protocol Compliance
Item
any co-morbidity that could limit compliance with the trial
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])