ID

22409

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00612183

Nyckelord

Versioner (1)
  1. 2017-06-02 2017-06-02 -
Uppladdad den

2 juni 2017

DOI

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Licens

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

Engelsk

Eligibility Non-Hodgkin's Lymphoma NCT00612183

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

non-hodgkin lymphoma, prior therapy

Datatyp

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.
Beskrivning

indolent b cell non-hodgkin lymphoma, mantle cell kymphoma

Datatyp

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.
Beskrivning

prior therapy, non responder

Datatyp

boolean

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

age

Datatyp

boolean

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

performance status

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

exclusion criteria

Datatyp

boolean

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

infection

Datatyp

boolean

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

hepatic failure or renal failure

Datatyp

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).
Beskrivning

heart failure, cardiac infarction, ischemic heart disease

Datatyp

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).
Beskrivning

serious digestive symptoms (nausea/ vomiting/ diarrhea)

Datatyp

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.
Beskrivning

hbv, hcv, hiv

Datatyp

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.
Beskrivning

other investigational drugs

Datatyp

boolean

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

allogenic bone-marrow transplant

Datatyp

boolean

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

pregnancy, childbearing potential, breast feeding

Datatyp

boolean

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

contraceptive methods

Datatyp

boolean

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

unsuitable

Datatyp

boolean

Alias
UMLS CUI [1]
C3844399
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Similar models

Eligibility Non-Hodgkin's Lymphoma NCT00612183

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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