ID

28335

Beschreibung

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Stichworte

Versionen (2)
  1. 30.11.17 30.11.17 -
  2. 04.01.18 04.01.18 -
Rechteinhaber

Prof. Dr. med. Georg Heß

Hochgeladen am

4. Januar 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Englisch

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 Formulare  
Admininstrative data
Beschreibung

Admininstrative data

Alias
UMLS CUI-1
C1320722
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI-1
C0680251
1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
Beschreibung

Lymphoma other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0205394
2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
Beschreibung

CNS involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C0449389
3. Pregnant or breastfeeding women
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
4. Severe concomitant disease
Beschreibung

e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinaemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243087
UMLS CUI [1,2]
C0205082
5. Myocardial infarction within the last 6 months
Beschreibung

Myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
Beschreibung

Hepatitis B Hepatitis C HIV-positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0019196
UMLS CUI [1,3]
C0019682
7. Vaccination with live vaccine within last 4 weeks
Beschreibung

Vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0042196
8. Mental status precluding patient's compliance
Beschreibung

Mental status compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0278060
UMLS CUI [1,2]
C1321605
9. Known CD20 negativity
Beschreibung

CD20 negativity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0054946
UMLS CUI [1,2]
C0205160
10. Diagnosed or treated for a malignancy other than NHL
Beschreibung

Except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the Cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >3 years, or prostate cancer with a life expectancy of more than 2 years

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
11. Treatment with any approved anticancer agent within last 2 weeks
Beschreibung

Any agents must have been stoppped at least 2 weeks prior to day 1 of GOAL treatment and all treatment-related adverse events must have returned to Grade 1.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0003392
12. Prior exposition to Obinutuzumab or Pixantrone
Beschreibung

therapy Obinutuzumab Pixantrone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2742503
UMLS CUI [1,3]
C0253355
13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
Beschreibung

Concurrent participation in non-treatment studies is not excluded.

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
Beschreibung

Compliance behavior Limited (extensiveness) Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Ähnliche Modelle

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Admininstrative data
C1320722 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Lymphoma other
Item
1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
boolean
C0024299 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
CNS involvement
Item
2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
boolean
C0449389 (UMLS CUI [1])
Pregnancy
Item
3. Pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
Severe concomitant disease
Item
4. Severe concomitant disease
boolean
C0243087 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Myocardial infarction
Item
5. Myocardial infarction within the last 6 months
boolean
C0027051 (UMLS CUI [1])
Hepatitis B Hepatitis C HIV-positive
Item
6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
boolean
C0019163 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0019682 (UMLS CUI [1,3])
Vaccination
Item
7. Vaccination with live vaccine within last 4 weeks
boolean
C0042196 (UMLS CUI [1])
Mental status compliance
Item
8. Mental status precluding patient's compliance
boolean
C0278060 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
CD20 negativity
Item
9. Known CD20 negativity
boolean
C0054946 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
comorbidity Malignant Neoplasms
Item
10. Diagnosed or treated for a malignancy other than NHL
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Treatment anticancer agent
Item
11. Treatment with any approved anticancer agent within last 2 weeks
boolean
C0920425 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
therapy Obinutuzumab Pixantrone
Item
12. Prior exposition to Obinutuzumab or Pixantrone
boolean
C0087111 (UMLS CUI [1,1])
C2742503 (UMLS CUI [1,2])
C0253355 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs
Item
13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
study subject participation status
Item
14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
boolean
C2348568 (UMLS CUI [1])
Compliance behavior Limited (extensiveness) Comorbidity
Item
15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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