ID

22100

Beschreibung

A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-Cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00389051

Link

https://clinicaltrials.gov/show/NCT00389051

Stichworte

Versionen (1)
  1. 19.05.17 19.05.17 -
Hochgeladen am

19. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Hodgkin's Lymphoma NCT00389051

Englisch

Eligibility Non-Hodgkin's Lymphoma NCT00389051

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

B-Cell Lymphoma indolent | Prior Therapy | Gender

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C0234227
UMLS CUI [2]
C1514463
UMLS CUI [3]
C0079399
patients with histologically or cytologically confirmed indolent b cell non-hodgkin's lymphoma.
Beschreibung

B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0079731
patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.
Beschreibung

Therapeutic procedure Absent | Chemotherapy | antibody therapy | Therapeutic radiology procedure | Prior Therapy Effects of Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0281176
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C1514463
UMLS CUI [5,2]
C1704420
UMLS CUI [5,3]
C0332268
patients aged from 20 to less than 75 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients who had agreed in-patient during first course therapy.
Beschreibung

First line treatment Inpatient Agree

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0021562
UMLS CUI [1,3]
C3641827
patients from whom written consent to participate in this study has been obtained.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
exclusion criteria:patients who meet any of the following criteria will be excluded.
Beschreibung

Exclusion Criteria

Datentyp

boolean

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

Communicable Diseases apparent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0750489
patients with serious complications (hepatic failure or renal failure).
Beschreibung

Complication Serious | Liver Failure | Kidney Failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0085605
UMLS CUI [3]
C0035078
patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
Beschreibung

Heart failure Serious Complication | Heart failure Serious | Myocardial Infarction | Myocardial Ischemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0009566
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0151744
patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
Beschreibung

Digestive symptom Serious | Nausea | Vomiting | Diarrhea

Datentyp

boolean

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

Hepatitis B positive | Hepatitis C positive | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699
patients receiving other investigational drugs within 3 months before registration in the study.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
patients with allogenic transplant.
Beschreibung

Transplantation, Homologous

Datentyp

boolean

Alias
UMLS CUI [1]
C0040739
women who are pregnant, of childbearing potential, or lactating.
Beschreibung

Pregnancy | Childbearing Potential | Breast Feeding

Datentyp

boolean

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

Contraceptive methods Disagree

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3641828
otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Non-Hodgkin's Lymphoma NCT00389051

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphoma indolent | Prior Therapy | Gender
Item
indolent b cell non-hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. no restrictions regarding gender.
boolean
C0079731 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
B-Cell Lymphoma
Item
patients with histologically or cytologically confirmed indolent b cell non-hodgkin's lymphoma.
boolean
C0079731 (UMLS CUI [1])
Therapeutic procedure Absent | Chemotherapy | antibody therapy | Therapeutic radiology procedure | Prior Therapy Effects of Lacking
Item
patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.
boolean
C0087111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0281176 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C1514463 (UMLS CUI [5,1])
C1704420 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
Age
Item
patients aged from 20 to less than 75 years.
boolean
C0001779 (UMLS CUI [1])
First line treatment Inpatient Agree
Item
patients who had agreed in-patient during first course therapy.
boolean
C1708063 (UMLS CUI [1,1])
C0021562 (UMLS CUI [1,2])
C3641827 (UMLS CUI [1,3])
Informed Consent
Item
patients from whom written consent to participate in this study has been obtained.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion criteria:patients who meet any of the following criteria will be excluded.
boolean
C0680251 (UMLS CUI [1])
Communicable Diseases apparent
Item
patients with apparent infections.
boolean
C0009450 (UMLS CUI [1,1])
C0750489 (UMLS CUI [1,2])
Complication Serious | Liver Failure | Kidney Failure
Item
patients with serious complications (hepatic failure or renal failure).
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
Heart failure Serious Complication | Heart failure Serious | Myocardial Infarction | Myocardial Ischemia
Item
patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
boolean
C0018801 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
Digestive symptom Serious | Nausea | Vomiting | Diarrhea
Item
patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
boolean
C0476288 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0027497 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
C0011991 (UMLS CUI [4])
Hepatitis B positive | Hepatitis C positive | HIV Seropositivity
Item
patients who are known to be positive for hbv, hcv or hic.
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Investigational New Drugs
Item
patients receiving other investigational drugs within 3 months before registration in the study.
boolean
C0013230 (UMLS CUI [1])
Transplantation, Homologous
Item
patients with allogenic transplant.
boolean
C0040739 (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 Disagree
Item
patients who do not agree to contraception.
boolean
C0700589 (UMLS CUI [1,1])
C3641828 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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