ID

27837

Descrição

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

Palavras-chave

Versões (2)
  1. 30/11/2017 30/11/2017 -
  2. 04/01/2018 04/01/2018 -
Titular dos direitos

Prof. Dr. med. Georg Heß

Transferido a

30 de novembro de 2017

DOI

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Licença

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

Inglês

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 Formulários  
Admininstrative data
Descrição

Admininstrative data

Subject ID
Descrição

Subject ID

Tipo de dados

text

Exclusion criteria
Descrição

Exclusion criteria

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

Other lymphoma

Tipo de dados

boolean

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

CNS involvement

Tipo de dados

boolean

3. Pregnant or breastfeeding women
Descrição

Pregnancy

Tipo de dados

boolean

4. Severe concomitant disease
Descrição

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

Tipo de dados

boolean

5. Myocardial infarction within the last 6 months
Descrição

Myocardial infarction within the last 6 months

Tipo de dados

boolean

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

Active uncontrolled infections

Tipo de dados

boolean

7. Vaccination with live vaccine within last 4 weeks
Descrição

Vaccination

Tipo de dados

boolean

8. Mental status precluding patient's compliance
Descrição

Mental status

Tipo de dados

boolean

9. Known CD20 negativity
Descrição

CD20 negativity

Tipo de dados

boolean

10. Diagnosed or treated for a malignancy other than NHL
Descrição

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

Tipo de dados

boolean

11. Treatment with any approved anticancer agent within last 2 weeks
Descrição

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.

Tipo de dados

boolean

12. Prior exposition to Obinutuzumab or Pixantrone
Descrição

exposition to Obinutuzumab or Pixantrone

Tipo de dados

boolean

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

hypersensitivity to medicinal products

Tipo de dados

boolean

14. Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation
Descrição

Concurrent participation in non-treatment studies is not excluded.

Tipo de dados

boolean

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

Medical or psychological conditions

Tipo de dados

boolean

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Similar models

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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