Leukemia, Myelocytic, Acute | Salvage second | Therapeutic procedure Quantity Refractory | Therapeutic procedure Quantity leukemia | Unresponsive to Treatment Primary
Item
confirmed diagnosis of acute myeloid leukemia (aml) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
boolean
C0023467 (UMLS CUI [1])
C0442967 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0205269 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0023418 (UMLS CUI [4,3])
C0205269 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
Induction Chemotherapy Quantity | Salvage second
Item
patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
boolean
C3179010 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0442967 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Relapse second | Complete remission second Duration | Complete Response with Incomplete Platelet Recovery second Duration
Item
patients who are in second relapse, must have had a duration of their second cr or crp of less than six months.
boolean
C0277556 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0677874 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C3890735 (UMLS CUI [3,1])
C0205436 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
Organ function | Immune function | Laboratory Results
Item
subjects must have adequate organ and immune function as indicated by the following laboratory values:
boolean
C0678852 (UMLS CUI [1])
C1817756 (UMLS CUI [2])
C1254595 (UMLS CUI [3])
Creatinine measurement, serum
Item
creatinine clearance ≥ 45 ml/min and ≤ 125 ml/min;
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin ≤ 2.0 mg/dl (≤ 34.2 µmol/l);
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast (sgot) and alt (sgpt) ≤ 3 x upper limit of normal (uln).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
ECOG performance status | Life Expectancy
Item
subjects must have an eastern cooperative oncology group (ecog) performance status of < 2, and an estimated life expectancy of at least eight weeks.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Central Nervous System Involvement Leukemia Evidence
Item
clinical evidence of active central nervous system (cns) leukemic involvement
boolean
C4050309 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
Communicable Disease Uncontrolled
Item
active and uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Patient Problem Uncontrolled | Informed Consent Limited | Therapeutic procedure Safety Limited
Item
uncontrolled medical problems unrelated to the malignancy that impair patient ability to give informed consent or unacceptably reduce the safety of the proposed treatment
boolean
C1254481 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0036043 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
nervous system disorder Interferes with Informed Consent | nervous system disorder Interferes with Clinical Study Follow-up | Mental disorders Interfere with Informed Consent | Mental disorders Interfere with Clinical Study Follow-up
Item
neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
boolean
C0027765 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
intolerance to Troxatyl | Hypersensitivity Troxatyl | intolerance to Troxatyl Suspected | Hypersensitivity Suspected Troxatyl | intolerance to Troxatyl Compound Related | Hypersensitivity Troxatyl Compound Related | intolerance to Lamivudine | Hypersensitivity Lamivudine | intolerance to Troxatyl Ingredients | Hypersensitivity Troxatyl Ingredients
Item
known or suspected intolerance or hypersensitivity to troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
boolean
C1744706 (UMLS CUI [1,1])
C0935960 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0935960 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0935960 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0935960 (UMLS CUI [4,3])
C1744706 (UMLS CUI [5,1])
C0935960 (UMLS CUI [5,2])
C1706082 (UMLS CUI [5,3])
C0439849 (UMLS CUI [5,4])
C0020517 (UMLS CUI [6,1])
C0935960 (UMLS CUI [6,2])
C1706082 (UMLS CUI [6,3])
C0439849 (UMLS CUI [6,4])
C1744706 (UMLS CUI [7,1])
C0209738 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0209738 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C0935960 (UMLS CUI [9,2])
C0085993 (UMLS CUI [9,3])
C0020517 (UMLS CUI [10,1])
C0935960 (UMLS CUI [10,2])
C0085993 (UMLS CUI [10,3])
Substance Use Disorders
Item
a recent history of alcohol or other substance abuse
boolean
C0038586 (UMLS CUI [1])
Investigational New Drugs | Study Subject Participation Status
Item
subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Pregnancy test positive
Item
females with a positive pregnancy test at screening
boolean
C0240802 (UMLS CUI [1])
Study Subject Participation Status | Patient withdrawn from trial
Item
subjects who have previously been enrolled into this study and subsequently withdrew
boolean
C2348568 (UMLS CUI [1])
C0422727 (UMLS CUI [2])