Acute myeloid leukaemia recurrent | Refractory Acute Myeloid Leukemia | Exception Acute Promyelocytic Leukemia | High Risk Myelodysplastic Syndrome IPSS | Blasts Percentage Bone Marrow
Item
1. all patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (aml) [except acute promyelocytic leukemia], or high-risk myelodysplastic syndrome (hrmds) (int-2 high risk by ipss or >10% blasts in marrow).
boolean
C1142169 (UMLS CUI [1])
C4528668 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0023487 (UMLS CUI [3,2])
C4528176 (UMLS CUI [4,1])
C2827405 (UMLS CUI [4,2])
C0368761 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C0005953 (UMLS CUI [5,3])
Age
Item
2. patients must be 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
3. patients must have a performance status of 0-2 (zubrod scale).
boolean
C3714786 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
4. patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dl and/or creatinine clearance > 40 ml/min). patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the principal investigator (pi) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Due to Leukemia | Exception Due to Hemolytic disorder | Exception Due to Bilirubin
Item
5. patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; sgot or sgpt less than or equal to 3x the uln for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). patients with hepatic dysfunction (sgot/sgpt up to less than or equal to 5 x uln) due to organ infiltration by disease may be eligible after discussion with the pi, and appropriate dose adjustments will be considered.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0023418 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C1263988 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0005437 (UMLS CUI [7,3])
Normal cardiac ejection fraction
Item
6. patients must have normal cardiac ejection fraction
boolean
C3661818 (UMLS CUI [1])
QTc interval
Item
7. qtc interval </= 480 msecs.
boolean
C0489625 (UMLS CUI [1])
Informed Consent
Item
8. patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
9. female patients must not be pregnant or lactating. female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Life-threatening infection Untreated | Life-threatening infection Uncontrolled
Item
1. patients must not have untreated or uncontrolled life-threatening infection.
boolean
C1859430 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Chemotherapy | Therapeutic radiology procedure | Hydroxyurea allowed Rapid disease progression | Hydroxyurea Dose U/day | Hydroxyurea To be stopped
Item
2. patients must not have received chemotherapy and/or radiation therapy within 2 weeks. hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of rapidly proliferating disease. use of hydroxyurea to control proliferative disease will be allowed starting from day 2 until day 7 cycle 1. maximum dose of hydroxyurea allowed daily is 5 gram and hydroxyurea must be discontinued once administration of idarubicin and cytarabine is started.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0020402 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C1834700 (UMLS CUI [3,3])
C0020402 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
C0020402 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Other medical condition Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Substance Use Disorder Interferes with Informed Consent | Other medical condition Interferes with Protocol Compliance | Mental disorder Interferes with Protocol Compliance | Substance Use Disorder Interferes with Protocol Compliance | Other medical condition Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status | Substance Use Disorder Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results | Substance Use Disorder Interferes with Interpretation Research results
Item
3. any other medical condition, including mental illness or substance abuse, deemed by the pi to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0038586 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0038586 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C0038586 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C3843040 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0459471 (UMLS CUI [10,3])
C0683954 (UMLS CUI [10,4])
C0004936 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0038586 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
Antineoplastic Agent Investigational
Item
4. patients must not have received an investigational anti-cancer drug within two weeks of e7070 administration.
boolean
C0003392 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])