Cd3+, cd57+, cd8+ cells
Item
phenotypic studies from peripheral blood showing cd3+, cd57+ cells greater than 400/mm3 or cd8+ cells greater than 650/mm3 within eight weeks prior to registration
boolean
C1267816 (UMLS CUI [1])
C0054965 (UMLS CUI [2])
C0085358 (UMLS CUI [3])
Clonal t-cell receptor gene rearrangement
Item
evidence for clonal t-cell receptor gene rearrangement within one year prior to registration
boolean
C1516680 (UMLS CUI [1])
Neutrophile count, recurrent infections, anemia or transfusion-dependent anemia
Item
at least one of the following: severe neutropenia less than 500/mm3, neutropenia associated with recurrent infections, symptomatic anemia, or transfusion-dependent anemia
boolean
C0200633 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
C0002871 (UMLS CUI [3])
C3666003 (UMLS CUI [4])
bilirubin, ast and creatinine measurement
Item
bilirubin ≤ 2.0 mg/dl, sgot(ast) ≤ 1.5 times normal, and creatinine ≤ 2.0 mg/dl within 4 weeks prior to registration
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201975 (UMLS CUI [3])
Ecog performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion criteria
Item
exclusion:
boolean
C0680251 (UMLS CUI [1])
Oral mtx or oral cy
Item
prior therapy with oral mtx or oral cy
boolean
C3238745 (UMLS CUI [1])
C1271102 (UMLS CUI [2])
Further malignancies
Item
previous or concurrent malignancies except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease free for over 5 years
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007114 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2216722 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0242793 (UMLS CUI [3,3])
Gynaecological status
Item
pregnant or breast-feeding for female patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity and informed consent
Item
serious medical illness, other than that treated by the study, which would limit survival to less than 2 years, or psychiatric condition which would prevent informed consent
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0004936 (UMLS CUI [2,3])
Disease response
Item
note: to be eligible for step 2 of this study, patients were required to have no response after at least 4 months of methotrexate treatment.
boolean
C1704632 (UMLS CUI [1])