Informed Consent
Item
provide signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
are at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
AML WHO classification
Item
have a diagnosis of aml according to world health organization (who) classification
boolean
C0023467 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
AML First Relapse | AML Unresponsive to Induction Therapy
Item
first relapsed or refractory aml (refractory to initial induction therapy)
boolean
C0023467 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
ECOG performance status
Item
have an ecog score of 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function | Renal function | Laboratory Results
Item
have adequate liver and renal function as indicated by certain laboratory values
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C1254595 (UMLS CUI [3])
Fertility Absent | Use of Contraceptive methods
Item
are nonfertile or agree to use an adequate method of contraception until 30 days after the last treatment
boolean
C0015895 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Induction Therapy Quantity AML
Item
have received more than 2 cycles of induction therapy for aml
boolean
C0600558 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
Unresponsive to Treatment | Recurrent disease | Status post IDAC protocol | Status post Cytarabine High dose
Item
refractory to or relapsed within the previous 3 months after therapy with an idac- or hidac-containing regimen
boolean
C0205269 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1173669 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0010711 (UMLS CUI [4,2])
C0444956 (UMLS CUI [4,3])
Hemopoietic stem cell transplant
Item
have received a hematopoietic stem cell transplant (hsct) within the previous 3 months
boolean
C0472699 (UMLS CUI [1])
Therapeutic immunosuppression Graft-vs-Host Disease
Item
have received active immunosuppressive therapy for graft-versus-host disease (gvhd) within 2 weeks before study start
boolean
C0021079 (UMLS CUI [1,1])
C0018133 (UMLS CUI [1,2])
Comorbidity Severe | Disease Serious | Heart Disease | Kidney Disease | Liver disease | Disease Organ system
Item
have any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0460002 (UMLS CUI [6,2])
Central Nervous System Involvement AML
Item
have evidence of central nervous system involvement of active aml
boolean
C4050309 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Cancer Other | Exception Skin carcinoma | Exception Cervical Intraepithelial Neoplasia | Hematologic Neoplasms
Item
have other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0206708 (UMLS CUI [3,2])
C0376545 (UMLS CUI [4])
Communicable Disease Uncontrolled
Item
have an active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Therapy, Investigational
Item
are receiving any other investigational therapy
boolean
C0949266 (UMLS CUI [1])
vosaroxin
Item
have received previous treatment with vosaroxin
boolean
C1451341 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Other medical condition Interferes with Informed Consent | Other medical condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Follow-up | Mental condition Interferes with Informed Consent | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Follow-up | Social situation Interferes with Informed Consent | Social situation Interferes with Study Subject Participation Status | Social situation Interferes with Follow-up
Item
have any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0021430 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C0748872 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C3274571 (UMLS CUI [9,3])