ID

27837

Descrizione

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

Keywords

versioni (2)
  1. 30/11/17 30/11/17 -
  2. 04/01/18 04/01/18 -
Titolare del copyright

Prof. Dr. med. Georg Heß

Caricato su

30 novembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

  • i più nuovi
  • i più vecchi
  • Popolare
  • i più nuovi
    • i più nuovi
    • i più vecchi
    • Popolare

Non ci sono commenti

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Inglese

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 moduli  
Admininstrative data
Descrizione

Admininstrative data

Subject ID
Descrizione

Subject ID

Tipo di dati

text

Exclusion criteria
Descrizione

Exclusion criteria

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

Other lymphoma

Tipo di dati

boolean

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

CNS involvement

Tipo di dati

boolean

3. Pregnant or breastfeeding women
Descrizione

Pregnancy

Tipo di dati

boolean

4. Severe concomitant disease
Descrizione

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

Tipo di dati

boolean

5. Myocardial infarction within the last 6 months
Descrizione

Myocardial infarction within the last 6 months

Tipo di dati

boolean

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

Active uncontrolled infections

Tipo di dati

boolean

7. Vaccination with live vaccine within last 4 weeks
Descrizione

Vaccination

Tipo di dati

boolean

8. Mental status precluding patient's compliance
Descrizione

Mental status

Tipo di dati

boolean

9. Known CD20 negativity
Descrizione

CD20 negativity

Tipo di dati

boolean

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

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 di dati

boolean

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

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 di dati

boolean

12. Prior exposition to Obinutuzumab or Pixantrone
Descrizione

exposition to Obinutuzumab or Pixantrone

Tipo di dati

boolean

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

hypersensitivity to medicinal products

Tipo di dati

boolean

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

Concurrent participation in non-treatment studies is not excluded.

Tipo di dati

boolean

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

Medical or psychological conditions

Tipo di dati

boolean

Ritorna all'inizio della pagina

Similar models

Screening Exclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
Ritorna all'inizio della pagina 

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial