ID

27836

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 Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

Englisch

Screening Inclusion criteria GOAL Trial B-cell Lymphoma NCT02499003

1 Formulare  
Admininstrative data
Beschreibung

Admininstrative data

Subject ID
Beschreibung

Subject ID

Datentyp

text

Inclusion Criteria
Beschreibung

Inclusion Criteria

1. Patients aged >=18 years
Beschreibung

Age

Datentyp

boolean

Trial Protocol Version 1.0: 2. CD20 positive disease
Beschreibung

Trial Protocol Version 2.0: Criterion 2 removed.

Datentyp

boolean

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)
Beschreibung

Diagnosis of lymphoma

Datentyp

boolean

4. Relapsed disease
Beschreibung

Relapsed disease

Datentyp

boolean

5. ECOG performance status =< 2, unless tumor associated
Beschreibung

ECOG performance status

Datentyp

boolean

Trial protocol version 1.0: 6. LVEF >= 45% and normal serum troponin
Beschreibung

LVEF

Datentyp

boolean

Trial protocol Version 2.0: 6. Adequate cardiac reserve
Beschreibung

Serum troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease

Datentyp

boolean

7. No curative option available
Beschreibung

No curative option available

Datentyp

boolean

8. At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
Beschreibung

tumor mass

Datentyp

boolean

9. Signed informed consent
Beschreibung

Signed informed consent

Datentyp

boolean

10. Adequate bone marrow reserve / hepatic and renal function
Beschreibung

Adequate bone marrow reserve: - Platelets of at least 100.000/μl (in case of extensive BM-Infiltration 75.000/μl may be acceptable after discussion with the coordinating investigator); - absolute neutrophil count of at least 1000/μl . Adequate hepatic and renal function: - ALT < 2.5 x upper limit of normal (ULN); - AST < 2.5 x ULN; - total Bilirubin < 1.5 x ULN.

Datentyp

boolean

11. No active Hepatitis B or C or HIV-infection
Beschreibung

Infections

Datentyp

boolean

12. Measured or calculated creatinine clearance > 30 ml/min
Beschreibung

creatinine clearance

Datentyp

boolean

13. Fresh tumor biopsy or archived tissue available
Beschreibung

Fresh tumor biopsy or archived tissue

Datentyp

boolean

14. Ability of patient to understand nature, importance and individual consequences of clinical trial
Beschreibung

Understanding patient

Datentyp

boolean

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.
Beschreibung

Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms /intrauterine devices (IUP) with spermicide.

Datentyp

boolean

16. Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
Beschreibung

contraception male patients

Datentyp

boolean

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Ähnliche Modelle

Screening Inclusion 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
Inclusion Criteria
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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