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ID
27836
Descripción
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
Palabras clave
Versiones (2)
- 30/11/17 30/11/17 -
- 4/1/18 4/1/18 -
Titular de derechos de autor
Prof. Dr. med. Georg Heß
Subido en
30 de noviembre de 2017
DOI
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Licencia
Creative Commons BY-NC 3.0
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Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003
Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003
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Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Subject ID
Item
Subject ID
text
Age
Item
1. Patients aged >=18 years
boolean
CD20 positive disease
Item
Trial Protocol Version 1.0: 2. CD20 positive disease
boolean
Diagnosis of lymphoma
Item
3. Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
boolean
Relapsed disease
Item
4. Relapsed disease
boolean
ECOG performance status
Item
5. ECOG performance status =< 2, unless tumor associated
boolean
LVEF
Item
Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
boolean
Adequate cardiac reserve
Item
Trial protocol Version 2.0: 6. Adequate cardiac reserve
boolean
No curative option available
Item
7. No curative option available
boolean
tumor mass
Item
8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
boolean
Signed informed consent
Item
9. Signed informed consent
boolean
bone marrow reserve hepatic and renal function
Item
10. Adequate bone marrow reserve / hepatic and renal function
boolean
Infections
Item
11. No active Hepatitis B or C or HIV-infection
boolean
creatinine clearance
Item
12. Measured or calculated creatinine clearance > 30 ml/min
boolean
Fresh tumor biopsy or archived tissue
Item
13. Fresh tumor biopsy or archived tissue available
boolean
Understanding patient
Item
14. Ability of patient to understand nature, importance and individual consequences of clinical trial
boolean
Pregnancy ruled out
Item
15. Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (Serum or Urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment.
boolean
contraception male patients
Item
16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
boolean
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