Age
Item
male or female patients aged ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Leukemia, Myelocytic, Acute | Standard of Care AML recurrent | Standard of Care Refractory AML | Standard of Care Unavailable | Standard of Care Refused
Item
documented definitive diagnosis of aml (according to who criteria, 2008) that is relapsed/refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy.
boolean
C0023467 (UMLS CUI [1])
C2936643 (UMLS CUI [2,1])
C1142169 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C4528668 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C2936643 (UMLS CUI [5,1])
C1705116 (UMLS CUI [5,2])
White Blood Cell Count procedure | Hydroxyurea allowed | Hydroxyurea Lowering White Blood Cell Count
Item
wbc count ≤ 10 x 109/l at visit 1 (day 1); hydroyxurea is allowed to lower wbc count up to one day prior the first study drug administration.
boolean
C0023508 (UMLS CUI [1])
C0020402 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0020402 (UMLS CUI [3,1])
C2003888 (UMLS CUI [3,2])
C0023508 (UMLS CUI [3,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 to 2 at visit 1 (day 1).
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 2 months.
boolean
C0023671 (UMLS CUI [1])
Laboratory test renal | Laboratory test hepatic | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Exception Organ Involvement with Leukemia | Serum total bilirubin measurement | Creatinine measurement, serum
Item
adequate renal and hepatic laboratory assessments: aspartate aminotransferase (ast), alanine aminotransferase (alt) and alkaline phosphatase (alp) ≤3.0 × uln, unless considered due to leukemic organ involvement, total bilirubin ≤2.0 × uln, serum creatinine ≤2.0 × uln.
boolean
C0022885 (UMLS CUI [1,1])
C0022646 (UMLS CUI [1,2])
C0022885 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0178784 (UMLS CUI [6,2])
C1314939 (UMLS CUI [6,3])
C0023418 (UMLS CUI [6,4])
C1278039 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
Informed Consent
Item
able to give written informed consent before any study related procedure
boolean
C0021430 (UMLS CUI [1])
Acute Promyelocytic Leukemia French-American-British Classification
Item
acute promyelocytic leukaemia (french-american-british m3 classification).
boolean
C0023487 (UMLS CUI [1,1])
C2984084 (UMLS CUI [1,2])
Central Nervous System Involvement
Item
active central nervous system involvement.
boolean
C4050309 (UMLS CUI [1])
Hemopoietic stem cell transplant
Item
haematopoietic stem cell transplantation (hsct) performed within 3 months prior to screening visit.
boolean
C0472699 (UMLS CUI [1])
Communicable Disease Requirement Antibiotics Intravenous
Item
active infection requiring intravenous antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003232 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
Life threatening illness compromises Patient safety | Life threatening illness Interferes with Protocol Compliance | Exception AML | Medical condition Uncontrolled | Organ system Dysfunction
Item
life-threatening illnesses other than aml, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the patient's ability to comply with the study activities.
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3846017 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0023467 (UMLS CUI [3,2])
C3843040 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0682591 (UMLS CUI [5,1])
C3887504 (UMLS CUI [5,2])
Cancer treatment | Exception Hydroxyurea
Item
anti-tumour therapy within 14 days of study visit 1 (day 1, excluding hydroxyurea).
boolean
C0920425 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020402 (UMLS CUI [2,2])
Study Subject Participation Status | Procedure Investigational | Investigational Medical Device
Item
prior participation in an investigational study (procedure or device) within 21 days of study visit 1 (day 1).
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3])
Therapeutic radiology procedure | Therapeutic radiology procedure Scheduled
Item
radiotherapy within 28 days prior to study visit 1 (day 1) or scheduled along the study conduct.
boolean
C1522449 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
HIV Infection | Hepatitis C | Hepatitis B
Item
known history of human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv).
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Breast Carcinoma | Exception Skin carcinoma
Item
other active malignancies. history of malignancy in the last 12 months (except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast or non-melanoma skin cancer).
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0699893 (UMLS CUI [6,2])