ID

27837

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

30. November 2017

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

Subject ID
Beschreibung

Subject ID

Datentyp

text

Exclusion criteria
Beschreibung

Exclusion criteria

1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
Beschreibung

Other lymphoma

Datentyp

boolean

2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
Beschreibung

CNS involvement

Datentyp

boolean

3. Pregnant or breastfeeding women
Beschreibung

Pregnancy

Datentyp

boolean

4. Severe concomitant disease
Beschreibung

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

Datentyp

boolean

5. Myocardial infarction within the last 6 months
Beschreibung

Myocardial infarction within the last 6 months

Datentyp

boolean

6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
Beschreibung

Active uncontrolled infections

Datentyp

boolean

7. Vaccination with live vaccine within last 4 weeks
Beschreibung

Vaccination

Datentyp

boolean

8. Mental status precluding patient's compliance
Beschreibung

Mental status

Datentyp

boolean

9. Known CD20 negativity
Beschreibung

CD20 negativity

Datentyp

boolean

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

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

12. Prior exposition to Obinutuzumab or Pixantrone
Beschreibung

exposition to Obinutuzumab or Pixantrone

Datentyp

boolean

13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
Beschreibung

hypersensitivity to medicinal products

Datentyp

boolean

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

15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
Beschreibung

Medical or psychological conditions

Datentyp

boolean

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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
Subject ID
Item
Subject ID
text
Item Group
Exclusion criteria
Other lymphoma
Item
1. Lymphoma other than DLBCL, FL IIIB, transfomed indolent NHL
boolean
CNS involvement
Item
2. CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
boolean
Pregnancy
Item
3. Pregnant or breastfeeding women
boolean
Severe concomitant disease
Item
4. Severe concomitant disease
boolean
Myocardial infarction within the last 6 months
Item
5. Myocardial infarction within the last 6 months
boolean
Active uncontrolled infections
Item
6. Active uncontrolled infections incl. HIV-positivity, active Hepatitis B or C
boolean
Vaccination
Item
7. Vaccination with live vaccine within last 4 weeks
boolean
Mental status
Item
8. Mental status precluding patient's compliance
boolean
CD20 negativity
Item
9. Known CD20 negativity
boolean
malignancy other than NHL
Item
10. Diagnosed or treated for a malignancy other than NHL
boolean
Treatment with anticancer agent
Item
11. Treatment with any approved anticancer agent within last 2 weeks
boolean
exposition to Obinutuzumab or Pixantrone
Item
12. Prior exposition to Obinutuzumab or Pixantrone
boolean
hypersensitivity to medicinal products
Item
13. History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
boolean
participation in other interventional clinical trials
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
Medical or psychological conditions
Item
15. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
boolean
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