Age | Acute lymphocytic leukemia recurrent | Acute lymphocytic leukemia refractory | Status post Prior Therapy | Acute biphenotypic leukemia in relapse CD22 Positive | Acute biphenotypic leukemia refractory CD22 Positive
Item
1. patients age 18 years or older with previously treated all (relapsed and/or refractory after prior therapy); patients with relapsed/refractory biphenotypic leukemia expressing the appropriate antigen (cd22) are also eligible to participate, pediatric patients younger than 18 may be considered with sponsor approval once the mtd has been established in the adult population.
boolean
C0001779 (UMLS CUI [1])
C1504403 (UMLS CUI [2])
C4049242 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C1514463 (UMLS CUI [4,2])
C4067209 (UMLS CUI [5,1])
C4329508 (UMLS CUI [5,2])
C0023464 (UMLS CUI [6,1])
C0205269 (UMLS CUI [6,2])
C4329508 (UMLS CUI [6,3])
ECOG performance status
Item
2. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Due to Neoplasm | Exception Due to Hemolysis | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Serum total bilirubin measurement | Exception Due to Hemolysis | Exception Due to Gilbert Disease
Item
3. adequate liver function (bilirubin less than or equal to 1.5 mg/dl and sgpt or sgot less than or equal 2.5 x upper limit of normal [uln], unless considered due to tumor or hemolysis), and renal function ( calculated crcl of greater than or equal to 50 or serum creatinine less than 2 x uln.) even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is less than or equal to 2.0 mg/dl (unless due to hemolysis or gilbert's disease, i.e. mainly indirect bilirubin) and creatinine less than or equal 2 mg/dl
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0027651 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C0019054 (UMLS CUI [6,3])
C0232804 (UMLS CUI [7])
C2711451 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
C1278039 (UMLS CUI [10])
C1705847 (UMLS CUI [11,1])
C0678226 (UMLS CUI [11,2])
C0019054 (UMLS CUI [11,3])
C1705847 (UMLS CUI [12,1])
C0678226 (UMLS CUI [12,2])
C0017551 (UMLS CUI [12,3])
Informed Consent
Item
4. provision of written informed consent.
boolean
C0021430 (UMLS CUI [1])
Heart Disease New York Heart Association Classification
Item
1. patient with active heart disease (nyha class greater than or equal to 2 as assessed by history and physical examination).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiac ejection fraction MUGA scan | Cardiac ejection fraction Echocardiography
Item
2. patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) less than 40%
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Hepatitis
Item
3. patients with active hepatitis
boolean
C0019158 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
4. pregnant or breast-feeding women. women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
Radioimmunotherapy
Item
5. prior radioimmunotherapy within 3 years of enrollment
boolean
C0085101 (UMLS CUI [1])
Serum albumin measurement
Item
6. serum albumin less than 2g/dl
boolean
C0523465 (UMLS CUI [1])
Oxygen saturation by pulse oximetry, resting | PaO2 measurement
Item
7. oxygen saturation at rest by pulse oximetry less than 88% or pao2 less than or equal to 55mm hg
boolean
C4736814 (UMLS CUI [1])
C1283004 (UMLS CUI [2])
Other Coding | Microangiopathic hemolytic anemia | Purpura, Thrombotic Thrombocytopenic | Hemolytic-Uremic Syndrome
Item
8. history of microangiopathic hemolysis, ttp or hus.
boolean
C3846158 (UMLS CUI [1])
C0221021 (UMLS CUI [2])
C0034155 (UMLS CUI [3])
C0019061 (UMLS CUI [4])
Central Nervous System Involvement Symptomatic
Item
9. symptomatic cns involvement
boolean
C4050309 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Status post Transplantation | Graft-vs-Host Disease
Item
10. less than 100 days post -transplant or any evidence of active gvhd
boolean
C0231290 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0018133 (UMLS CUI [2])
Systemic Chemotherapy
Item
11. systemic chemotherapy less than 14 days prior; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigator
boolean
C1883256 (UMLS CUI [1])
Monoclonal Antibody Therapy
Item
12. monoclonal antibody therapy less than 1 month
boolean
C0279694 (UMLS CUI [1])
Investigational New Drugs
Item
13. investigational agents within 28 days of dosing; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the principal investigator
boolean
C0013230 (UMLS CUI [1])
HIV Seropositivity | AIDS
Item
14. hiv+/aids
boolean
C0019699 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Exposure to Pseudomonas exotoxin Containing Molecule
Item
15. history of exposure to pseudomonas exotoxin containing molecule
boolean
C0332157 (UMLS CUI [1,1])
C0072544 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0567416 (UMLS CUI [1,4])
Infectious Lung Disorder | Pulmonary Edema
Item
16. patients with active lung infection or active pulmonary edema.
boolean
C0876973 (UMLS CUI [1])
C0034063 (UMLS CUI [2])
Laboratory test finding Consistent with Disseminated Intravascular Coagulation Grade | Disseminated Intravascular Coagulation Grade
Item
17. patients with laboratory findings consistent with grade equal to greater than 3 disseminated intravascular coagulation (dic) or any grade 2 dic that does not correct.
boolean
C0587081 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0012739 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
C0012739 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Ophthalmological test finding Clinical Significance
Item
18. patients with clinically significant ophthalmologic findings (as determined by an ophthalmologist) during screening should be excluded from the trial
boolean
C0429488 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Prolonged QTc interval
Item
19. pre-treatment greater than qtc interval of 490 ms
boolean
C1560305 (UMLS CUI [1])