Leukemia TdT Positive | TdT Positive Acute Lymphoblastic Leukemia | AML TdT Positive | Blastic Phase CML TdT Positive | Standard therapy Quantity failed | Standard therapy Unexpected Resulting in Remission | Blast cells present Percentage Bone Marrow | Blast cells present Percentage Peripheral blood | Blast cells present Percentage
Item
tdt-positive leukemia (all, aml, or blastic cml) that has failed at least one standard treatment regimen and for which no standard therapies are expected to result in durable remission. leukemia is minimally defined as at least 20% blast cells present in marrow or peripheral blood. tdt must be expressed in at least 20% of blast cells present and documented either immunologically or biochemically;
boolean
C0023418 (UMLS CUI [1,1])
C0012881 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C2348656 (UMLS CUI [2])
C0023467 (UMLS CUI [3,1])
C0012881 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0005699 (UMLS CUI [4,1])
C0012881 (UMLS CUI [4,2])
C1514241 (UMLS CUI [4,3])
C2936643 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
C2936643 (UMLS CUI [6,1])
C4055646 (UMLS CUI [6,2])
C0332294 (UMLS CUI [6,3])
C0544452 (UMLS CUI [6,4])
C0427540 (UMLS CUI [7,1])
C0439165 (UMLS CUI [7,2])
C0005953 (UMLS CUI [7,3])
C0427540 (UMLS CUI [8,1])
C0439165 (UMLS CUI [8,2])
C0229664 (UMLS CUI [8,3])
C0427540 (UMLS CUI [9,1])
C0439165 (UMLS CUI [9,2])
Age
Item
age ≥18 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
must understand and voluntarily sign informed consent;
boolean
C0021430 (UMLS CUI [1])
Organ function | Exception Hematologic function
Item
adequate non-hematologic organ system function, defined by:
boolean
C0678852 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0221130 (UMLS CUI [2,2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine ≤1.5 times the upper limit of normal (uln) and/or creatinine clearance ≥60 ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and/or alt ≤2.5 times upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Bilirubin total normal
Item
total bilirubin within institutional normal range
boolean
C0860928 (UMLS CUI [1])
ECG normal | LVEF Electrocardiography | LVEF MUGA scan | LVEF Radionuclide Ventriculography | LVEF Echocardiography
Item
normal ekg and lvef >40%, measured by ekg and muga scan, radionuclide ventriculogram, or echocardiogram
boolean
C0522054 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0521317 (UMLS CUI [3,2])
C0428772 (UMLS CUI [4,1])
C0034610 (UMLS CUI [4,2])
C0428772 (UMLS CUI [5,1])
C0013516 (UMLS CUI [5,2])
Life Expectancy
Item
life expectancy >3 months;
boolean
C0023671 (UMLS CUI [1])
Karnofsky Performance Status | ECOG performance status
Item
performance status (ps) >70% karnofsky or ecog ≤2;
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Childbearing Potential Serum pregnancy test negative | Hysterectomy Absent | Postmenopausal state Absent | Normal menstruation
Item
women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study drug. a woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months);
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0020699 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0559892 (UMLS CUI [4])
Females & males of reproductive potential Contraceptive methods
Item
male or female of child-bearing potential must agree to use adequate contraceptive methods
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Inclusion criteria Fulfill failed
Item
failure to meet inclusion criteria;
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Communicable Disease Uncontrolled
Item
uncontrolled active infection;
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Disease Extramedullary | CNS disorder
Item
extramedullary (cns) disease;
boolean
C0012634 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
C0007682 (UMLS CUI [2])
Comorbidity Serious | Communicable Disease | Congestive heart failure Uncontrolled | Diabetic - poor control | Metabolic Disease Uncontrolled | Mental disorders
Item
serious concomitant medical illness, such as active infection, uncontrolled congestive heart failure, or uncontrolled diabetes or other metabolic disorder, or psychiatric illness;
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0421258 (UMLS CUI [4])
C0025517 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0004936 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
pregnancy or lactation; females of child bearing potential must use adequate contraceptive methods;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Prior Chemotherapy | Prior radiation therapy | Prior Immunotherapy | Hydroxyurea allowed
Item
less than 3 weeks since prior chemotherapy, radiation therapy, or immunotherapy. however, hydroxyurea is permitted up to 24 hours before the study is initiated;
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C1514461 (UMLS CUI [3])
C0020402 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Bone Marrow Transplantation | Peripheral Stem Cell Transplantation | Donor Lymphocyte Infusion
Item
less than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (dli).
boolean
C0005961 (UMLS CUI [1])
C0242602 (UMLS CUI [2])
C1512034 (UMLS CUI [3])