AML or ALL
Item
diagnosis of aml or all, relapsed or refractory after at least 1 prior treatment regimen. newly-diagnosed patients ≥ 60 years old who have refused or are considered unfit for standard chemotherapy regimens or stem cell transplantation are also eligible.
boolean
C0023467 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
no available approved therapies that confer clinical benefit
Item
patients must have no available approved therapies that confer clinical benefit
boolean
C0470187 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0814225 (UMLS CUI [1,3])
bone marrow involvement of their tumor
Item
all patients must have bone marrow involvement of their tumor, with documented blast percentage of > 5%.
boolean
C1517677 (UMLS CUI [1])
C0368761 (UMLS CUI [2])
peripheral blood blast count
Item
peripheral blood blast count must be ≤ 30,000 cells/µl.
boolean
C0368761 (UMLS CUI [1])
ECOG
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
hepatic, renal and cardiac function
Item
adequate hepatic, renal, and cardiac function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232164 (UMLS CUI [3])
current malignancy
Item
any other current malignancy
boolean
C0006826 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
APL
Item
patients with acute promyelocytic leukemia (apl)
boolean
C0023487 (UMLS CUI [1])
treatment with an unapproved, investigational agent
Item
treatment with an unapproved, investigational agent within 21 days of the first dose of study drug
boolean
C1875319 (UMLS CUI [1])
stem cell transplant
Item
allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 90 days prior to to the first dose of study drug
boolean
C1504389 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
C1512034 (UMLS CUI [2])
active GvHD
Item
active gvhd
boolean
C0018133 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
unable to receive medications by mouth
Item
unable to receive medications by mouth
boolean
C0175795 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
major surgery
Item
major surgery within 28 days before cycle 1 day 1
boolean
C0679637 (UMLS CUI [1])
uncontrolled, active infection
Item
uncontrolled, active infection; patients who are known to have hiv infection/seropositivity, hepatitis a, b, or c, or cmv reactivation
boolean
C0009450 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0582172 (UMLS CUI [4])
neurotoxicity/neuropathy
Item
significant neurotoxicity/neuropathy (grade 3 or higher) within 14 days prior to day 1
boolean
C0235032 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
nausea and vomiting
Item
refractory nausea and vomiting or other situation that may preclude adequate absorption
boolean
C0027497 (UMLS CUI [1])
C0042963 (UMLS CUI [2])
C0000854 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
conditions that could interfere with treatment and procedures
Item
conditions that could interfere with treatment and procedures
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])