ID

14319

Beschrijving

Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00003910

Link

https://clinicaltrials.gov/show/NCT00003910

Trefwoorden

Versies (1)
  1. 10-04-16 10-04-16 -
Geüploaded op

10 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT00003910

Engels

Eligibility Leukemia NCT00003910

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00003910
Criteria
Beschrijving

Criteria

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
Beschrijving

Cd3+, cd57+, cd8+ cells

Datatype

boolean

Alias
UMLS CUI [1]
C1267816
UMLS CUI [2]
C0054965
UMLS CUI [3]
C0085358
evidence for clonal t-cell receptor gene rearrangement within one year prior to registration
Beschrijving

Clonal t-cell receptor gene rearrangement

Datatype

boolean

Alias
UMLS CUI [1]
C1516680
at least one of the following: severe neutropenia less than 500/mm3, neutropenia associated with recurrent infections, symptomatic anemia, or transfusion-dependent anemia
Beschrijving

Neutrophile count, recurrent infections, anemia or transfusion-dependent anemia

Datatype

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0239998
UMLS CUI [3]
C0002871
UMLS CUI [4]
C3666003
bilirubin ≤ 2.0 mg/dl, sgot(ast) ≤ 1.5 times normal, and creatinine ≤ 2.0 mg/dl within 4 weeks prior to registration
Beschrijving

bilirubin, ast and creatinine measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201975
ecog performance status of 0-2
Beschrijving

Ecog performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
at least 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent
Beschrijving

Written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
exclusion:
Beschrijving

Exclusion criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
prior therapy with oral mtx or oral cy
Beschrijving

Oral mtx or oral cy

Datatype

boolean

Alias
UMLS CUI [1]
C3238745
UMLS CUI [2]
C1271102
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
Beschrijving

Further malignancies

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007114
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C2216722
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0242793
pregnant or breast-feeding for female patients
Beschrijving

Gynaecological status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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
Beschrijving

Comorbidity and informed consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0004936
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.
Beschrijving

Disease response

Datatype

boolean

Alias
UMLS CUI [1]
C1704632
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Similar models

Eligibility Leukemia NCT00003910

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00003910
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
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])
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