acute myeloid leukemia; allogeneic hematopoietic stem cell transplant; HLA Antigens
Item
subject has a diagnosis of acute myeloid leukemia (aml) according to who classification (2008) and has received a high dose or a reduced intensity conditioning allogeneic hematopoietic stem cell transplant (hsct) during first or second remission and within 30 to 60 days prior to first dose of ac220. donors may be human leukocyte antigen (hla)-matched for hla-a, b, c, drb1, and dqb1 by high resolution typing, related or unrelated (only a single allele disparity will be allowed for hla-a, b, or c as defined by high resolution typing) note: more than one hsct is allowed
boolean
C0023467 (UMLS CUI [1])
C1456094 (UMLS CUI [2])
C0019721 (UMLS CUI [3])
Cancer Remission; marrow blasts; Central nervous system leukaemia
Item
subject must be in morphologic remission (< 5% marrow blasts) and without active central nervous system (cns) aml within 14 days prior to first dose of ac220
boolean
C0687702 (UMLS CUI [1])
C1982687 (UMLS CUI [2])
C1332884 (UMLS CUI [3])
chimerism; screening
Item
subject must have cd3 donor chimerism > 50 % at screening
boolean
C0333678 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
karnofsky performance status
Item
subject has a karnofsky performance status (kps) of ≥ 60
boolean
C0206065 (UMLS CUI [1])
absolute neutrophil count; platelet count; platelet transfusion
Item
subject must have absolute neutrophil count (anc) > 1000/mm3 and platelet count > 50,000/mm3 without platelet transfusion support within 2 weeks prior to first dose
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0086818 (UMLS CUI [3])
laboratory renal hepatic coagulation
Item
subject must have adequate renal, hepatic, and coagulation parameters
boolean
C0681902 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0205054 (UMLS CUI [1,3])
C0005778 (UMLS CUI [1,4])
pregnancy; lactating
Item
female subjects must not be lactating and must not be breastfeeding at screening or during the study period and for 28 days [or five half lives of the study drug whichever is longer] after final study drug administration.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
compliance
Item
subject is able to comply with study procedures and follow-up examinations
boolean
C1321605 (UMLS CUI [1])
therapy ac220; Cancer Relapse
Item
subject received ac220 and relapsed during treatment with ac220
boolean
C0087111 (UMLS CUI [1,1])
C2348498 (UMLS CUI [1,2])
C0699753 (UMLS CUI [2])
graft versus host disease
Item
subject has active ≥ grade 2 graft versus host disease (gvhd)
boolean
C0018133 (UMLS CUI [1])
concurrent therapy chemotherapy immunotherapy radiotherapy
Item
subject has received concurrent chemotherapy, immunotherapy, or radio-therapy within 21 days prior to the first dose of ac220, or any antineoplastic therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation) within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
boolean
C0009429 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0021083 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
concomitant medication; Prolonged QT interval; immunosuppressants; antibiotics; antifungals
Item
subject requires treatment with concomitant drugs that prolong qt/qtc interval or strong cytochrome p-3a4 (cyp3a4) inhibitors or inducers with the exception of immunosuppressants, antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject
boolean
C2347852 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0003232 (UMLS CUI [4])
C0003308 (UMLS CUI [5])
anticoagulant therapy
Item
subject requires treatment with anticoagulant therapy
boolean
C0150457 (UMLS CUI [1])
hiv positive; Hepatitis B Surface Antigens
Item
subject has a known positive test for human immunodeficiency virus, hepatitis c, or hepatitis b surface antigen
boolean
C0019699 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
major surgery; dosage ac220
Item
subject had major surgery within 4 weeks prior to first dose of ac220
boolean
C0679637 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C2348498 (UMLS CUI [2,2])
cardiovascular disease
Item
subject has uncontrolled or significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
infection; Unresponsive to Treatment
Item
subject has an active acute fungal, bacterial, or other infection that is unresponsive to therapy
boolean
C3714514 (UMLS CUI [1])
C0205269 (UMLS CUI [2])
Study Subject Participation Status
Item
subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of screening.
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
subject has any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])