T-Cell Acute Lymphoblastic Leukemia | Lymphoblastic T-cell lymphoma
Item
histologic or cytogenetic documented diagnosis of t-all or t-lbl.
boolean
C1961099 (UMLS CUI [1])
C2853920 (UMLS CUI [2])
Chemotherapy Regimen Quantity | Refractory Disease | Recurrent disease Post Complete remission
Item
disease that is refractory to at least one prior chemotherapy regimen, or has relapsed following complete remission to at least one prior chemotherapy regimen.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1514815 (UMLS CUI [2])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0677874 (UMLS CUI [3,3])
Chemotherapy Last Time last dose | Therapeutic radiology procedure | 506U78 | Blast Cells Growth
Item
at least 4 weeks since the last dose of prior last chemotherapy, or radiotherapy before beginning treatment with 506u78 (2 weeks is permitted if growth of blast cells is significant).
boolean
C0392920 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2])
C0759671 (UMLS CUI [3])
C0368761 (UMLS CUI [4,1])
C0220844 (UMLS CUI [4,2])
Organ system function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Transaminases Hepatic | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Serum total bilirubin measurement T-ALL Related | Serum total bilirubin measurement T-LBL Related
Item
adequate function of other organ systems as measured as follows.serum creatinine is less than 1.5 times of upper limit of normal and estimated creatinine clearance >=50 ml/min. hepatic transaminases (sgpt and sgot) <=3 x upper limit of normal, bilirubin is less than 1.5 times of upper limit of normal(<=5 x upper limit of normal if it is related by t-all or t-lbl).
boolean
C0460002 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0002594 (UMLS CUI [4,1])
C0205054 (UMLS CUI [4,2])
C0201836 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C1278039 (UMLS CUI [8,1])
C1961099 (UMLS CUI [8,2])
C0439849 (UMLS CUI [8,3])
C1278039 (UMLS CUI [9,1])
C2853920 (UMLS CUI [9,2])
C0439849 (UMLS CUI [9,3])
ECOG performance status
Item
adequate performance status (ecog-ps<=2).
boolean
C1520224 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Hospitalization Willing | Blood sampling Pharmacokinetics Measurement
Item
patient is willing to accept hospitalization during the blood sampling for pharmacokinetic measurement (i.e., cohort 1: for pharmacokinetic sample collection during both cycle 1 and 2; and cohort 2: for pharmacokinetic sample collection during cycle 1).
boolean
C0019993 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0031328 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods | Female infertility | Postmenopausal state | Menstruation absent Duration
Item
female subjects who are of child-bearing potential must have a negative pregnancy test at the screening visit and agree to utilize contraceptive methods during participation in the study and for at least six months following the last dose of 506u78 injection. female subjects may be defined as of non-child-bearing potential if they are physiologically incapable of becoming pregnant, including any female who is post-menopausal. for purposes of this study, postmenopausal is defined as one year without menses.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0021361 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0497456 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
Communicable Disease
Item
active infection at time of treatment.
boolean
C0009450 (UMLS CUI [1])
Comorbidity Study Subject Participation Status Inappropriate
Item
concurrent disease or condition that would make the subject inappropriate for study participation.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Antineoplastic Agents | Study Subject Participation Status | Investigational New Drugs
Item
receiving any other anticancer agents or enrolled on any investigational study during the course of the study.
boolean
C0003392 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Chemotherapy | CTCAE Grades Patient recovered
Item
patients must have recovered to grade i or less toxicity of all previous chemotherapy prior to treatment.
boolean
C0392920 (UMLS CUI [1])
C1516728 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
Seizures
Item
history of seizure disorder within one year prior to the date of informed consent.
boolean
C0036572 (UMLS CUI [1])
Pregnancy Pregnancy test positive | Breast Feeding | Fertility Contraceptive methods
Item
pregnancy (as demonstrated by a positive pregnancy test at pre-study/screening) or breastfeeding. fertile women and men must practice adequate contraception throughout the study and at least 6 month after the last dose of study drug.
boolean
C0032961 (UMLS CUI [1,1])
C0240802 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0015895 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])