ID

22409

Description

Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00612183

Link

https://clinicaltrials.gov/show/NCT00612183

Keywords

Versions (1)
  1. 6/2/17 6/2/17 -
Uploaded on

June 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00612183

English

Eligibility Non-Hodgkin's Lymphoma NCT00612183

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. no restrictions regarding gender.
Description

non-hodgkin lymphoma, prior therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1514463
patients with histologically or cytologically confirmed indolent b cell non-hodgkin's lymphoma or mantle cell lymphoma.
Description

indolent b cell non-hodgkin lymphoma, mantle cell kymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C0079731
UMLS CUI [1,3]
C0024305
UMLS CUI [2]
C0334634
patients who had not received treatment for at least 4 weeks (for at least 12 weeks in the case of antibody therapy) after completion of prior therapy and who are judged to carry no effect from the prior therapy.
Description

prior therapy, non responder

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0919875
patients aged from 20 to less than 75 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status (p.s.): 0 or 1.
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions).
Description

organ function bone marrow, heart, lung, liver, and kidney

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0005953
UMLS CUI [2]
C0232164
UMLS CUI [3]
C0231921
UMLS CUI [4]
C0232741
UMLS CUI [5]
C0232804
patients from whom written consent to participate in this study has been obtained.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any of the following criteria will be excluded.
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
patients with apparent infections.
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C3714514
patients with serious complications (hepatic failure or renal failure).
Description

hepatic failure or renal failure

Data type

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0035078
patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
Description

heart failure, cardiac infarction, ischemic heart disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0027051
UMLS CUI [1,3]
C0151744
patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
Description

serious digestive symptoms (nausea/ vomiting/ diarrhea)

Data type

boolean

Alias
UMLS CUI [1,1]
C0205404
UMLS CUI [1,2]
C0476288
UMLS CUI [1,3]
C0027497
UMLS CUI [1,4]
C0042963
UMLS CUI [1,5]
C0011991
patients who are known to be positive for hbv, hcv or hiv.
Description

hbv, hcv, hiv

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0019196
UMLS CUI [1,3]
C0019682
patients receiving other investigational drugs within 3 months before registration in the study.
Description

other investigational drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients with allogenic bone-marrow transplant.
Description

allogenic bone-marrow transplant

Data type

boolean

Alias
UMLS CUI [1]
C0149615
women who are pregnant, of childbearing potential, or lactating.
Description

pregnancy, childbearing potential, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
patients who do not agree to contraception.
Description

contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
Description

unsuitable

Data type

boolean

Alias
UMLS CUI [1]
C3844399
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00612183

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
non-hodgkin lymphoma, prior therapy
Item
non-hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. no restrictions regarding gender.
boolean
C0024305 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
indolent b cell non-hodgkin lymphoma, mantle cell kymphoma
Item
patients with histologically or cytologically confirmed indolent b cell non-hodgkin's lymphoma or mantle cell lymphoma.
boolean
C1334170 (UMLS CUI [1,1])
C0079731 (UMLS CUI [1,2])
C0024305 (UMLS CUI [1,3])
C0334634 (UMLS CUI [2])
prior therapy, non responder
Item
patients who had not received treatment for at least 4 weeks (for at least 12 weeks in the case of antibody therapy) after completion of prior therapy and who are judged to carry no effect from the prior therapy.
boolean
C1514463 (UMLS CUI [1,1])
C0919875 (UMLS CUI [1,2])
age
Item
patients aged from 20 to less than 75 years.
boolean
C0001779 (UMLS CUI [1])
performance status
Item
performance status (p.s.): 0 or 1.
boolean
C1518965 (UMLS CUI [1])
organ function bone marrow, heart, lung, liver, and kidney
Item
patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions).
boolean
C0678852 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0232164 (UMLS CUI [2])
C0231921 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
informed consent
Item
patients from whom written consent to participate in this study has been obtained.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exclusion criteria
Item
patients who meet any of the following criteria will be excluded.
boolean
C0680251 (UMLS CUI [1])
infection
Item
patients with apparent infections.
boolean
C3714514 (UMLS CUI [1])
hepatic failure or renal failure
Item
patients with serious complications (hepatic failure or renal failure).
boolean
C0085605 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
heart failure, cardiac infarction, ischemic heart disease
Item
patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
boolean
C0018801 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0151744 (UMLS CUI [1,3])
serious digestive symptoms (nausea/ vomiting/ diarrhea)
Item
patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
boolean
C0205404 (UMLS CUI [1,1])
C0476288 (UMLS CUI [1,2])
C0027497 (UMLS CUI [1,3])
C0042963 (UMLS CUI [1,4])
C0011991 (UMLS CUI [1,5])
hbv, hcv, hiv
Item
patients who are known to be positive for hbv, hcv or hiv.
boolean
C0019163 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0019682 (UMLS CUI [1,3])
other investigational drugs
Item
patients receiving other investigational drugs within 3 months before registration in the study.
boolean
C0013230 (UMLS CUI [1])
allogenic bone-marrow transplant
Item
patients with allogenic bone-marrow transplant.
boolean
C0149615 (UMLS CUI [1])
pregnancy, childbearing potential, breast feeding
Item
women who are pregnant, of childbearing potential, or lactating.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
contraceptive methods
Item
patients who do not agree to contraception.
boolean
C0700589 (UMLS CUI [1])
unsuitable
Item
otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
boolean
C3844399 (UMLS CUI [1])
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