Age
Item
male or female greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
Leukemia, Myelocytic, Acute; Unresponsive to Treatment | Leukemia, Myelocytic, Acute; Relapse | Age | chronic myelogenous leukemia in relapse; Treated with; fludarabine | Chronic Lymphocytic Leukemia; Treated with; Alkylating Agents
Item
have one of the following disease states: acute myeloid leukemia (aml) (age <60 years) with relapsed/refractory disease; chronic lymphocytic leukemia (cll) with relapsed disease following a fludarabine-based regimen or relapsed disease following an alkylator-based regimen
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0278787 (UMLS CUI [4,1])
C0332293 (UMLS CUI [4,2])
C0059985 (UMLS CUI [4,3])
C0023434 (UMLS CUI [5,1])
C0332293 (UMLS CUI [5,2])
C0002073 (UMLS CUI [5,3])
Recovery from ; Alopecia Adverse Event | Neuropathy; Adverse event
Item
are recovered from the acute adverse effects of prior therapies (excluding alopecia and grade ≤2 neuropathy).
boolean
C2004454 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C0002170 (UMLS CUI [2])
C0442874 (UMLS CUI [3])
Blast cell count measurement; Controlled by; hydroxyurea
Item
have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000 mg daily).
boolean
C0427541 (UMLS CUI [1,1])
C0332298 (UMLS CUI [1,2])
C0020402 (UMLS CUI [1,3])
adequate hepatic function; renal function
Item
have adequate hepatic function and renal function
boolean
C1848676 (UMLS CUI [1])
C0232805 (UMLS CUI [2])
life expectancy
Item
have an estimated life expectancy of >3 months
boolean
C0023671 (UMLS CUI [1])
Contraception status | serum pregnancy test
Item
female subject must have a negative serum pregnancy result within 7 days before the start of the study; both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for 3 months after discontinuation of treatment
boolean
C0420837 (UMLS CUI [1])
C0430064 (UMLS CUI [2])
Eligibility for lifesaving or life-prolonging standard therapy
Item
are eligible for any standard therapy known to be life prolonging or life saving
boolean
FAB type M3
Item
have diagnosis of aml french-american-british (fab) classification (fab) m3 (acute promyelocytic leukemia (apl))
boolean
C0457329 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Biological treatment | Hormone Therapy
Item
are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or hormonal treatment for cancer.
boolean
C3665472 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
Chemotherapy | Hormone Therapy | Immunotherapy | hydroxyurea
Item
have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of other investigational agents within 4 weeks before study entry.
boolean
C3665472 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0020402 (UMLS CUI [4])
Therapeutic radiology procedure; Bone Marrow; Percent (qualifier value)
Item
prior radiation therapy with volume of bone marrow treated over 25%.
boolean
C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
History of immunosuppressive therapy | Steroid therapy
Item
use of immunosuppressive therapy, including systemic steroids within 7 days before the first dose of sg2000.
boolean
C0455630 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
hyperleukocytosis
Item
hyperleukocytosis (blast counts >30 000/mm3).
boolean
C3805210 (UMLS CUI [1])
Organ Transplantation | Allogeneic Stem Cell Transplantation
Item
history of allogeneic stem cell or solid organ transplantation.
boolean
C0029216 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
HIV Seropositivity | hepatitis b serology | hepatitis C serology test | Acquired Immunodeficiency Syndrome
Item
positive serology for human immunodeficiency virus (hiv), hepatitis b or hepatitis c or have hiv-aids, or active hepatitis b or c.
boolean
C0019699 (UMLS CUI [1])
C0744837 (UMLS CUI [2])
C0850489 (UMLS CUI [3])
C0001175 (UMLS CUI [4])
invasive cancer | Carcinoma in Situ | Malignant neoplasm of skin; Nonmelanomatous
Item
history of other invasive malignancy within 3 years except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured.
boolean
C0677898 (UMLS CUI [1])
C0007099 (UMLS CUI [2])
C0007114 (UMLS CUI [3,1])
C1518408 (UMLS CUI [3,2])
Study Subject Participation Status; limited by - ActRelationshipType; Disease
Item
have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1549479 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Informed Consent; limited by - ActRelationshipType; Mental disorders
Item
have psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies.
boolean
C0021430 (UMLS CUI [1,1])
C1549479 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
Toxicity Grade | Alopecia | Peripheral Neuropathy
Item
have persistent grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).
boolean
C2826262 (UMLS CUI [1])
C0002170 (UMLS CUI [2])
C0031117 (UMLS CUI [3])
Patient currently pregnant | Breast Feeding
Item
are pregnant or breast-feeding.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])